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Trial registered on ANZCTR
Registration number
ACTRN12625000972426
Ethics application status
Approved
Date submitted
10/08/2025
Date registered
3/09/2025
Date last updated
3/09/2025
Date data sharing statement initially provided
3/09/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluating the effect of 'Partners in Parenting-Peer-to-Parent' (PiP-P2P) program for parents of adolescents with anxiety and depression on parenting skills and adolescent anxiety and depression symptoms
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Scientific title
Prospective, parallel-group intention-to-treat randomised-controlled trial (RCT) to examine the effect of a peer-coach supported, online parenting program (‘Partners in Parenting-Peer-to-Parent; PiP-P2P’) for parents of adolescents with anxiety and depression, on parenting skills and adolescent anxiety and depression symptoms
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Secondary ID [1]
314692
0
Nil known
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Universal Trial Number (UTN)
U1111-1321-1351
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parenting risk and protective factors for adolescent depression and anxiety disorders
337868
0
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Parental self-efficacy
337869
0
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Adolescent depression
337870
0
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Adolescent anxiety
337871
0
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Carer burden
337872
0
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Condition category
Condition code
Public Health
334197
334197
0
0
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Health promotion/education
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Public Health
334198
334198
0
0
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Health service research
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Mental Health
334199
334199
0
0
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Anxiety
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Mental Health
334200
334200
0
0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention, ‘Partners in Parenting-Peer-to-Parent (PiP-P2P)’, is a newly adapted version of a therapist-coach assisted online parenting program, Partners in Parenting Plus (PiP+; formerly known as the Therapist-assisted Online Parenting Strategies [TOPS] program; refer to ACTRN12618000290291). The original PiP+ program is an online parenting program designed to equip parents (refers to any adult in a regular caregiving role) with evidence-based parenting strategies to respond to anxiety or depression in their 12-18-year-old adolescent. Adaptations of PiP+ have since been developed to address specific areas of concern, including school refusal (Partners in Parenting Plus-Education [PiP-Ed+], refer to ACTRN12622000977774) and suicide prevention (Partners in Parenting Plus-Suicide Prevention [PiP-SP+], refer to ACTRN12623000266662).
In PiP-P2P, the coaching support that is provided by trained clinicians in PiP+ is instead provided by family/carer peer coaches, who are family/carer peer support workers with lived experience (FCWLE) of caring for an adolescent with mental health difficulties.
This intervention has two components:
1) a web-based program drawn from the Partners in Parenting intervention (refer to ACTRN12615000328572 and ACTRN12619001781134) which includes a parenting self-assessment with tailored feedback about the parent's current parenting practices and up to 10 web-based modules); and,
2) a coaching component (refer to ACTRN12618000290291) delivered via videoconference, henceforth referred to as ‘PiP-P2P coaching sessions’.
The web-based program includes 10 self-directed online modules covering topics related to parenting an adolescent with anxiety and/or depression: 1) understanding anxiety and depression, 2) parent-teen relationships, 3) minimising conflict in the home, 4) parental involvement and autonomy granting, 5) problem-solving, 6) breaking the anxiety cycle, 7) establishing family rules, 8) encouraging good habits, 9) encouraging supportive relationships, and 10) relapse prevention.
The coaching component involves parents attending a maximum of 10 PiP-P2P coaching sessions with a PiP-P2P coach via online videoconference. Prior to their first session, parents will receive a phone call from a member of the coaching team. The purpose of the phone call will be to introduce the coach and the program to the parent, and confirm the first coaching session.
Parents will be encouraged to complete their PiP-P2P coaching sessions weekly, and will have a maximum of 14 weeks to complete up to 10 coaching sessions. The PiP-P2P coaching sessions will expand on the content of the modules, and peer coaches will draw on their own lived experience to support the parent to apply the content to their own circumstances. Discussions around goal setting and enabling goal attainment are also a focus of these sessions. PiP-P2P coaching sessions are manualised to ensure standardised delivery of the intervention. Each session takes approximately 50-minutes.
PiP-P2P coaches will all be family/carer peer workers with lived experience (FCWLE), who have experience working as a family peer worker at a headspace centre or equivalent setting in Australia. headspace is Australia’s National Youth Mental Health Foundation, providing early intervention mental health services to 12-25 year olds and their families. Coaches will receive standardised training and regular supervision to deliver the manualised PiP-P2P coaching sessions.
Note: Adolescents will not participate in PiP-P2P coaching sessions. It will be recommended that the adolescent receives standard psychological care externally to the intervention as required. Non-participant co-parents of the participating parent will be permitted to join PiP-P2P coaching sessions if requested.
Parents will receive the following as part of the PiP-P2P intervention:
1) Parents first complete an online self-assessment of their parenting practices associated with risk of adolescent depression and anxiety disorders (the Parenting to Reduce Adolescent Depression and Anxiety Scale [PRADAS]). The PRADAS assesses parenting practices in relation to the recommendations in the evidence-base parenting guidelines "How to Prevent Depression and Clinical Anxiety in your Teenager: Strategies for Parents" (Parenting Strategies Program, 2013; henceforth the Guidelines), which form the basis of the program content.
2) Based on their responses to the PRADAS, parents receive an individually-tailored feedback report. The feedback highlights areas of parenting strength and/or confidence, and provides practical strategies for identified areas for improvement. The feedback report is displayed to parents online (via their 'personal dashboard' as part of the PiP website).
3) Parents are recommended up to 10 interactive online modules.
All parents in the current trial will be required to select the following modules, regardless of PRADAS responses, as these are considered critical foundational topics for the program: 1) understanding anxiety and depression, and 2) relapse prevention. Similarly, the parent-teen relationships module will always be recommended, regardless of PRADAS responses. The remaining modules will be recommended based on identified areas for improvement (scores on corresponding PRADAS subscales).
The modules provide practical strategies to support parents to make changes to their parenting, in order to align more closely with the parenting recommendations in the Guidelines. Parents can further tailor their program by selecting additional modules or de-selecting optional modules recommended to them. In addition to the 2 mandatory modules, parents can select between 1 to 8 additional modules to comprise their personalised program. By default, modules will ‘unlock’ (i.e. become available for parents to complete) at a rate of one module per week, until all selected modules have been unlocked. Parents are notified by email and SMS (if they opt in to SMS notifications) when a new module unlocks. If they prefer, parents can choose to override the default unlock date, and unlock modules at an earlier date. After all initially-selected modules have been unlocked, all remaining modules, including those not initially selected, will automatically become available for parents to complete if they wish. Parents can revisit any modules they have already completed at any time.
The interactive modules can be accessed online, from any device with internet access (including smartphones). The modules include educational materials, illustrations, audio clips, videos, vignettes, interactive activities, goal-setting exercises, and an end-of-module quiz with immediate feedback to consolidate learning. Each module takes approximately 20-35 minutes to complete, depending on the topic and how parents engage with the module. Parents are invited to complete their first module immediately after they have completed their baseline survey and received their personalised feedback report.
4) In parallel, parents will attend a maximum of 10 one-on-one PiP-P2P coaching sessions with a PiP-P2P coach via online videoconference. Parents will have a maximum of 14 weeks to complete the 10 PiP-P2P coaching sessions and be encouraged to attend weekly. In each session parents will be guided by their coach through a check-in, a review of the module content, completion of an activity, and a goal-setting exercise, with a view to work towards their selected module goal between PiP-P2P coaching sessions.
Intervention adherence will be monitored through website analytics (e.g., module completion) and attendance records (coaching sessions). Intervention engagement will be explored through: 1) percentage of selected modules completed; and 2) percentage of selected module goals completed.
Modules are considered completed if 80% of pre-specified mandatory activities are completed.
Goal completion will be defined as: a user (the parent, or coach, if applicable) indicates that the selected module goal was ‘attempted’.
Intervention outcomes will be assessed through parent and adolescent online surveys completed at two timepoints: baseline and at post-intervention (120 days/4 months after the parent baseline assessment); and a post-intervention interview with a subgroup of n~15 parents.
Reference:
Cardamone-Breen, M. C., Jorm, A. F., Lawrence, K. A., Mackinnon, A. J., & Yap, M. B. (2017). The Parenting to Reduce Adolescent Depression and Anxiety Scale: Assessing parental concordance with parenting guidelines for the prevention of adolescent depression and anxiety disorders. PeerJ, 5, e3825.
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Intervention code [1]
331297
0
Behaviour
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Comparator / control treatment
Self-guided PiP - Parents will receive the self-guided version of PiP, as described below.
1) Parents first complete an online self-assessment of their parenting practices associated with risk of adolescent depression and anxiety disorders (the PRADAS). The PRADAS assesses parenting practices in relation to the recommendations in the evidence-base parenting guidelines, the Guidelines, which form the basis of the program content.
2) Based on their responses to the PRADAS, parents receive an individually-tailored feedback report. The feedback highlights areas of parenting strength and/or confidence, and provides practical strategies for identified areas for improvement. The feedback report is displayed to parents online (via their 'personal dashboard' as part of the PiP website).
3) Parents are recommended up to 10 interactive online modules.
All parents in the current trial will be required to select the following modules, regardless of PRADAS responses, as these are considered critical foundational topics for the program: 1) understanding anxiety and depression, and 2) relapse prevention. Similarly, the parent-teen relationships module will always be recommended, regardless of PRADAS responses. The remaining modules will be recommended based on identified areas for improvement (scores on corresponding PRADAS subscales).
The modules provide practical strategies to support parents to make changes to their parenting, in order to align more closely with the parenting recommendations in the Guidelines. Parents can further tailor their program by selecting additional modules or de-selecting optional modules recommended to them. In addition to the 2 mandatory modules, parents can select between 1 to 8 additional modules to comprise their personalised program. By default, modules will ‘unlock’ (i.e. become available for parents to complete) at a rate of one module per week, until all selected modules have been unlocked. Parents are notified by email and SMS (if they opt in to SMS notifications) when a new module unlocks. If they prefer, parents can choose to override the default unlock date, and unlock modules at an earlier date. After all initially-selected modules have been unlocked, all remaining modules, including those not initially selected, will automatically become available for parents to complete if they wish. Parents can revisit any modules they have already completed at any time.
The interactive modules can be accessed online, from any device with internet access (including smartphones). The modules include educational materials, illustrations, audio clips, videos, vignettes, interactive activities, goal-setting exercises, and an end-of-module quiz with immediate feedback to consolidate learning. Each module takes approximately 20-35 minutes to complete, depending on the topic and how parents engage with the module. Parents are invited to complete their first module immediately after they have completed their baseline survey and received their personalised feedback report.
Intervention adherence will be monitored through website analytics (e.g., module completion). Intervention engagement will be explored through: 1) percentage of selected modules completed; and 2) percentage of selected module goals completed.
Modules are considered completed if 80% of pre-specified mandatory activities are completed.
Goal completion will be defined as: a user (the parent, or coach, if applicable) indicates that the selected module goal was ‘attempted’.
Intervention outcomes will be assessed through parent and adolescent online surveys completed at two timepoints: baseline and at post-intervention (120 days/4 months after the parent baseline assessment).
Reference:
Cardamone-Breen, M. C., Jorm, A. F., Lawrence, K. A., Mackinnon, A. J., & Yap, M. B. (2017). The Parenting to Reduce Adolescent Depression and Anxiety Scale: Assessing parental concordance with parenting guidelines for the prevention of adolescent depression and anxiety disorders. PeerJ, 5, e3825.
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Control group
Active
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Outcomes
Primary outcome [1]
342432
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Parenting risk and protective factors for adolescent depression and anxiety disorders (henceforth ‘parenting skills’; quantitative)
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Assessment method [1]
342432
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Parenting skills that parents can potentially modify will be assessed as a composite outcome. This will be measured by the total score on the Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS; Cardamone-Breen et al., 2017). The PRADAS is a composite measure of several parenting skills, hence the total score is the outcome of interest. The PRADAS contains 79 items across nine subscales (with 6-12 items each): Parent-child relationship, Involvement, Relationships with others, Family rules, Home environment, Health habits, Dealing with problems, Coping with anxiety, and Professional help-seeking. Each subscale corresponds with a section of the Guidelines. Items are scored as either 0 (response non-concordant with Guidelines) or 1 (response concordant with Guidelines). The Relationships with others subscale is excluded from the PRADAS total score when used as an outcome measure. Items are then summed to obtain an overall score ranging from 0 to 73. Higher scores indicate higher levels of concordance with the Guidelines. Reference: Cardamone-Breen, M. C., Jorm, A. F., Lawrence, K. A., Mackinnon, A. J., & Yap, M. B. H. (2017). The Parenting to Reduce Adolescent Depression and Anxiety Scale: Assessing parental concordance with parenting guidelines for the prevention of adolescent depression and anxiety disorders. PeerJ, 5, e3825.
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Timepoint [1]
342432
0
1) Pre-intervention (baseline survey package). 2) Post-intervention: 4-months (120 days, primary timepoint) from baseline assessment completion date. 3) Follow-up: 12-months (360 days) from baseline assessment completion date.
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Secondary outcome [1]
450789
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Parental self-efficacy for managing the risk of adolescent depression and anxiety (quantitative)
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Assessment method [1]
450789
0
Parents’ self-efficacy in their ability to engage in behaviours that can reduce the risk or impact of adolescent depression and anxiety disorders will be assessed as a composite outcome. This will be measured by the total score on the Parental Self-Efficacy for reducing the risk of adolescent depression and anxiety Scale (PSES; Nicolas et al., 2020). The PSES contains 9 items that align with the nine PRADAS subscales, scored on a 4-point Likert scale. One item (relating to the Coping with anxiety subscale of the PRADAS) is excluded from the PSES total score when it is used as an outcome measure. Items are then summed to obtain a total score ranging from 8 to 32. Higher scores indicate higher levels of parental self-efficacy for preventing or reducing the risk of adolescent depression and anxiety. Reference: Nicolas, C. C., Jorm, A. F., Cardamone-Breen, M. C., Lawrence, K. A., & Yap, M. B. (2020). Parental self-efficacy for reducing the risk of adolescent depression and anxiety: scale development and validation. Journal of Research on Adolescence, 30(1), 249-265.
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Timepoint [1]
450789
0
1) Pre-intervention (baseline survey package). 2) Post-intervention: 4-months (120 days) from baseline assessment completion date. 3) Follow-up: 12-months (360 days) from baseline assessment completion date.
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Secondary outcome [2]
450790
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Parent anxiety symptoms (quantitative)
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Assessment method [2]
450790
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Changes to symptoms of anxiety experienced by the parent will be measured by the General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006). The GAD-7 contains 7 items, which are scored on a 4-point Likert scale, and summed to obtain an overall score ranging from 0 to 21. Higher scores indicate higher levels of anxiety. Reference: Spitzer, R. L., Kroenke, K., Williams, J. B. W., & Löwe, B. (2006). A brief measure for assessing generalized anxiety disorder: The GAD-7. Arch Intern Med, 166(10), 1092-1097.
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Timepoint [2]
450790
0
1) Pre-intervention (baseline survey package). 2) Post-intervention: 4-months (120 days) from baseline assessment completion date. 3) Follow-up: 12-months (360 days) from baseline assessment completion date.
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Secondary outcome [3]
450791
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Parent depressive symptoms (quantitative)
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Assessment method [3]
450791
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Changes to symptoms of depression experienced by the parent will be measured by the Patient Health Questionnaire-8 (PHQ-8; Kroenke et al., 2009). The PHQ-8 contains 8 items, which are scored on a 4-point Likert scale, and summed to obtain an overall score ranging from 0 to 24. Higher scores indicate higher levels of depression. Reference: Kroenke, K., Strine, T. W., Spitzer, R. L., Williams, J. B., Berry, J. T., Mokdad, A. H. The PHQ-8 as a measure of current depression in the general population. J Affect Disord, 114(1-3), 163-173.
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Timepoint [3]
450791
0
1) Pre-intervention (baseline survey package). 2) Post-intervention: 4-months (120 days) from baseline assessment completion date. 3) Follow-up: 12-months (360 days) from baseline assessment completion date.
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Secondary outcome [4]
450792
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Carer burden (quantitative)
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Assessment method [4]
450792
0
Changes to carer burden experienced by the parent as objective and subjective consequences will be measured by the Caregiver Strain Questionnaire-Short Form 11 (CGSQ-SF11; Brennan et al., 2022). The CGSQ-SF11 contains 11 items across three subscales (with 3-4 items each): Objective strain, Subjective externalized strain, and Subjective internalized strain. Items are scored on a 5-point Likert scale, and scores for items of each subscale are averaged to calculate subscale scores. Subscale scores are summed to obtain a global score. Higher scores indicate higher levels of carer burden. Reference: Brennan, G. M., Babinski, D. E., & Waschbusch, D. A. (2022). Caregiver Strain Questionnaire–Short Form 11 (CGSQ-SF11): A Validation Study. Assessment, 29(7), 1351-1370.
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Timepoint [4]
450792
0
1) Pre-intervention (baseline survey package). 2) Post-intervention: 4-months (120 days) from baseline assessment completion date. 3) Follow-up: 12-months (360 days) from baseline assessment completion date.
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Secondary outcome [5]
450793
0
Carer gains (quantitative)
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Assessment method [5]
450793
0
Changes to parent gratifications and positive psychological states arising from caregiving (henceforth ‘carer gains’) will be measured by the Uplifts subscale of the Revised Burden Measure (Montgomery & Kosloski, 2006). The Uplifts subscale contains 6 items, scored on a 5-point Likert scale. A subscale score is obtained by calculating the mean of the items, with higher scores indicating higher levels of carer gains. Reference: Montgomery, R. J. V., & Kosloski, K. (2006). The league of experienced family caregivers: measure development. University of Wisconsin-Milwaukee.
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Timepoint [5]
450793
0
1) Pre-intervention (baseline survey package). 2) Post-intervention: 4-months (120 days) from baseline assessment completion date. 3) Follow-up: 12-months (360 days) from baseline assessment completion date.
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Secondary outcome [6]
450794
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Adolescent anxiety symptoms by parent report (quantitative)
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Assessment method [6]
450794
0
To measure changes in adolescent anxiety symptoms by parent report, the Revised Child Anxiety and Depression Scale 25-Parent Version (RCADS-P-25; Ebesutani et al., 2017) will be administered. The RCADS-25-P contains 25 items across two subscales: Total Anxiety (15 items) and Total Depression (10 items). Items are scored on a 4-point Likert scale. Scores on the 15 Total Anxiety subscale items are summed to obtain raw scores (ranging from 0 to 45), which are then converted to T-scores ranging from 32 to >80. Higher scores indicate higher levels of anxiety. References: Ebesutani, C., Reise, S. P., Chorpita, B. F., Ale, C., Regan, J., Young, J., Higa-McMillan, C., & Weisz, J. R. (2012). The Revised Child Anxiety and Depression Scale-Short Version: Scale reduction via exploratory bifactor modeling of the broad anxiety factor. Psychological Assessment, 24(4), 833-845. Chorpita, B. F., Yim, L. M., Moffitt, C. E., Umemoto L. A., & Francis, S. E. (2000). Assessment of symptoms of DSM-IV anxiety and depression in children: A Revised Child Anxiety and Depression Scale. Behaviour Research and Therapy, 38, 835-855.
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Timepoint [6]
450794
0
1) Pre-intervention (baseline survey package). 2) Post-intervention: 4-months (120 days) from baseline assessment completion date. 3) Follow-up: 12-months (360 days) from baseline assessment completion date.
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Secondary outcome [7]
450795
0
Adolescent depression symptoms by parent report (quantitative)
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Assessment method [7]
450795
0
To measure changes in adolescent depression symptoms by parent report, the Revised Child Anxiety and Depression Scale 25-Parent Version (RCADS-P-25; Ebesutani et al., 2017) will be administered. The RCADS-25-P contains 25 items across two subscales: Total Anxiety (15 items) and Total Depression (10 items). Items are scored on a 4-point Likert scale. Scores on the 10 Total Depression subscale items are summed to obtain raw scores (ranging from 0 to 30), which are then converted to T-scores ranging from 35 to >80. Higher scores indicate higher levels of depression. References: Ebesutani, C., Reise, S. P., Chorpita, B. F., Ale, C., Regan, J., Young, J., Higa-McMillan, C., & Weisz, J. R. (2012). The Revised Child Anxiety and Depression Scale-Short Version: Scale reduction via exploratory bifactor modeling of the broad anxiety factor. Psychological Assessment, 24(4), 833-845. Chorpita, B. F., Yim, L. M., Moffitt, C. E., Umemoto L. A., & Francis, S. E. (2000). Assessment of symptoms of DSM-IV anxiety and depression in children: A Revised Child Anxiety and Depression Scale. Behaviour Research and Therapy, 38, 835-855.
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Timepoint [7]
450795
0
1) Pre-intervention (baseline survey package). 2) Post-intervention: 4-months (120 days) from baseline assessment completion date. 3) Follow-up: 12-months (360 days) from baseline assessment completion date.
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Secondary outcome [8]
450796
0
Adolescent anxiety symptoms by adolescent report (quantitative)
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Assessment method [8]
450796
0
To measure changes in adolescent anxiety symptoms by adolescent report, the Revised Child Anxiety and Depression Scale 25 (RCADS-25; Ebesutani et al., 2012) will be administered. The RCADS-25 contains 25 items across two subscales: Total Anxiety (15 items) and Total Depression (10 items). Items are scored on a 4-point Likert scale. Scores on the 15 Total Anxiety subscale items are summed to obtain raw scores (ranging from 0 to 45), which are then converted to T-scores ranging from 27 to >80. Higher scores indicate higher levels of anxiety. References: Ebesutani, C., Reise, S. P., Chorpita, B. F., Ale, C., Regan, J., Young, J., Higa-McMillan, C., & Weisz, J. R. (2012). The Revised Child Anxiety and Depression Scale-Short Version: Scale reduction via exploratory bifactor modeling of the broad anxiety factor. Psychological Assessment, 24(4), 833-845. Chorpita, B. F., Yim, L. M., Moffitt, C. E., Umemoto L. A., & Francis, S. E. (2000). Assessment of symptoms of DSM-IV anxiety and depression in children: A Revised Child Anxiety and Depression Scale. Behaviour Research and Therapy, 38, 835-855.
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Timepoint [8]
450796
0
1) Pre-intervention (baseline survey package). 2) Post-intervention: 4-months (120 days) from parent baseline assessment completion date. 3) Follow-up: 12-months (360 days) from baseline assessment completion date.
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Secondary outcome [9]
450797
0
Adolescent depression symptoms by adolescent report (quantitative)
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Assessment method [9]
450797
0
To measure changes in adolescent anxiety symptoms by adolescent report, the Revised Child Anxiety and Depression Scale 25 (RCADS-25; Ebesutani et al., 2012) will be administered. The RCADS-25 contains 25 items across two subscales: Total Anxiety (15 items) and Total Depression (10 items). Items are scored on a 4-point Likert scale. Scores on the 10 Total Depression subscale items are summed to obtain raw scores (ranging from 0 to 30), which are then converted to T-scores ranging from 27 to >80. Higher scores indicate higher levels of depression. References: Ebesutani, C., Reise, S. P., Chorpita, B. F., Ale, C., Regan, J., Young, J., Higa-McMillan, C., & Weisz, J. R. (2012). The Revised Child Anxiety and Depression Scale-Short Version: Scale reduction via exploratory bifactor modeling of the broad anxiety factor. Psychological Assessment, 24(4), 833-845. Chorpita, B. F., Yim, L. M., Moffitt, C. E., Umemoto L. A., & Francis, S. E. (2000). Assessment of symptoms of DSM-IV anxiety and depression in children: A Revised Child Anxiety and Depression Scale. Behaviour Research and Therapy, 38, 835-855.
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Timepoint [9]
450797
0
1) Pre-intervention (baseline survey package). 2) Post-intervention: 4-months (120 days) from parent baseline assessment completion date. 3) Follow-up: 12-months (360 days) from baseline assessment completion date.
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Secondary outcome [10]
450798
0
Adolescent perceived quality of parental support (quantitative)
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Assessment method [10]
450798
0
To measure changes in adolescent reports of perceived quality of mental health parental support provided by their parent, the Mental Health Support Scale-Provided, Adapted (MHSS-P Adapted) will be administered. All items will be used with adapted phrasing to be self-report of mental health support received, excluding 1 item about thoughts of self-harm that will not be included. The 11 items are scored on a dichotomous Yes (1) / No (0) response scale (including 3 items that are reverse-scored) and summed to obtain an overall score ranging from 0 to 11, with higher scores indicating higher quality of mental health support. Reference: Morgan, A. J., Wright, J., Mackinnon, A. J., Reavley, N. J., Rossetto, A., & Jorm, A. F. (2022). Development of the Mental Health Support Scale: A New Measure of Mental Health First Aid Behaviors. Assessment. https://doi.org/10.1177/10731911221106767
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Timepoint [10]
450798
0
1) Pre-intervention (baseline survey package). 2) Post-intervention: 4-months (120 days) from parent baseline assessment completion date. 3) Follow-up: 12-months (360 days) from baseline assessment completion date.
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Secondary outcome [11]
450799
0
Parent satisfaction with the program (quantitative)
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Assessment method [11]
450799
0
Parent satisfaction with the program received will be measured using the Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982; Larsen et al., 1979). The CSQ-8 contains 8 items, scored on 4-point Likert scales. Items are summed to obtain an overall score ranging from 8 to 32, with higher scores indicating higher levels of overall satisfaction with the service. In this questionnaire, service is defined for participants as the PiP program, which “may include any of the following: online modules, personalised feedback, email and phone contact, coaching support, etc.” Reference: Attkisson, C. C., & Zwick, R. (1982). Client Satisfaction Questionnaire-8 (CSQ-8) [Database record]. APA PsycTests. Larsen, D. L., Attkisson, C. C., Hargreaves, W. A., & Nguyen, T. D. (1979). Assessment of client/patient satisfaction: development of a general scale. Evaluation and program planning, 2(3), 197-207.
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Timepoint [11]
450799
0
1) Post-intervention: 4-months (120 days) from baseline assessment completion date.
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Secondary outcome [12]
450800
0
Process evaluation: Intervention Group only (qualitative)
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Assessment method [12]
450800
0
In-depth qualitative data about the acceptability and appropriateness of parent coaching, (2) effectiveness and perceived behavioural changes resulting from PiP-P2P, and (3) contextual factors that may have influenced parents’ engagement with PiP-P2P will be collected through semi-structured interviews. Approximately 20 participating parents and their adolescents (if the adolescent consents) will be interviewed. Parents will be purposively sampled, by a research team member not involved in interviews or analysis, from those with higher and lower levels of engagement with PiP-P2P, and a range of sample characteristics (e.g. parent or adolescent mental health, sociodemographics).
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Timepoint [12]
450800
0
1) Post-intervention: Approximately 4-months (120 days) from baseline assessment completion date.
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Eligibility
Key inclusion criteria
Group 1:
Parents and/or guardians of adolescents aged 12-17 years who:
- Are concerned about their adolescent’s anxiety and/or depression
- Have sought professional support for their adolescent’s mental health problems (i.e., depression or anxiety) within the past 6 months
- Have regular contact with their adolescent
- Can read, write, speak, and hear in English
- Have regular access to the internet (including email) and a device with video-conferencing capabilities
- Live in Victoria
Group 2:
Adolescents (aged 12-17 years) of participating parents who:
- Are the identified adolescent of the parent participant
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Group 1: Parents
1. Parents of an adolescent with a principal mental health condition of sufficient severity to require immediate clinical prioritisation (e.g. current alcohol/substance dependence, acute mental health crisis, recent suicide attempt or inpatient treatment) will not be eligible to participate in the trial.
Justification: The intensity of the program is unlikely to be sufficient for families with such complexities, who would likely require more targeted and multidisciplinary treatment.
2. Parents who are already engaged in another form of parenting intervention (e.g., parenting program, family therapy) with or without their adolescent.
Justification: The PiP intervention involves parenting work, hence it may be contra-indicated alongside other parenting or family therapy treatment.
3. Parents who are experiencing a crisis or ongoing, high level of distress.
Justification: The focus and intensity of the program is not sufficient for parents who are in crisis and likely require targeted support for their own mental health and wellbeing. The program is focused on their adolescent's emerging anxiety and depression.
Group 2: Adolescents
There are no additional exclusion criteria beyond the above mentioned criteria for parents. All adolescents of parents deemed eligible will be eligible to participate.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Stratified permuted block randomisation will be used to conceal allocation.
When parents submit their baseline assessment on the trial website, they will be automatically allocated to the intervention or active-control group through stratified permuted block randomisation, through the website. Parents find out their allocation immediately thereafter: both groups receive their tailored feedback, the Parenting Guidelines, and the online parenting program as described above. The intervention group will be contacted by a member of the coaching team to introduce the coach and the coaching program to the parent, and confirm their first session. As such, allocation is concealed from both participants and researchers prior to random assignment.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified permuted block randomisation. The random sequence generation will be automated within the dedicated trial website. Each parent will be assigned to the intervention or active-control condition in a 1:1 ratio via stratified permuted block randomisation, using pre-generated lists of blocks of 4 or 6 for each strata. Parents will be stratified on two variables:
1. Adolescent age on parent date of registration
2. Whether the adolescent is elevated on either or both of the RCADS-P subscales
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/02/2026
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Actual
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Date of last participant enrolment
Anticipated
1/09/2026
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Actual
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Date of last data collection
Anticipated
31/12/2027
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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The Medical Research Future Fund (MRFF), Department of Health
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
321708
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.monash.edu/researchoffice/ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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21/01/2025
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Approval date [1]
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04/03/2025
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Ethics approval number [1]
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46221
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Summary
Brief summary
The purpose of this study is to evaluate the effectiveness of an evidence-based peer coaching online parenting intervention (PiP-P2P) as compared to the non-coached self-guided online parenting intervention (PiP) in parents of adolescents aged 12-17 years with emerging mental health problems. The program aims to build parenting skills and confidence by equipping parents with evidence-based parenting strategies that are associated with reduced risk and impact of depression and anxiety disorders in adolescents. The PiP program comprises up to 10 self-guided, online modules covering different topics related to parenting and adolescent mental health. In this trial, we aim to evaluate: 1) the effectiveness of PiP-P2P compared to self-guided PiP in improving parenting skills, parental self-efficacy, parental anxiety and depression symptoms, caregiver strain, carer burden, carer gains, adolescent depression and anxiety symptoms, and adolescent perceived quality of parental support, and 2) whether intervention engagement (percentage of PiP modules and PiP goals completed) mediates the effects of the intervention on parent and adolescent outcomes. We hypothesise that compared to PiP, PiP-P2P will produce greater improvements in parent and adolescent outcomes from pre- to post-intervention and at follow-up. It is also hypothesised that greater improvements in outcomes from PiP-P2P compared to PiP will be explained by greater intervention engagement in PiP-P2P.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Marie Yap
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Address
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School of Psychological Sciences, Building 17, 18 Innovation Walk, Monash University, Clayton, Victoria 3800
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Country
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Australia
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Phone
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+61 3 9905 0723
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Marie Yap
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Address
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School of Psychological Sciences, Building 17, 18 Innovation Walk, Monash University, Clayton, Victoria 3800
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Country
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Australia
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Phone
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+61 3 9903 4042
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Marie Yap
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Address
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School of Psychological Sciences, Building 17, 18 Innovation Walk, Monash University, Clayton, Victoria 3800
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Country
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Australia
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Phone
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+61 3 9905 0723
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Fax
142260
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
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Anyone
Conditions for requesting access:
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Available to anyone based on Primary Investigator discretion.
What individual participant data might be shared?
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De-identified individual participant data:
What types of analyses could be done with individual participant data?
•
Any purpose approved by the Primary Investigator.
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Access subject to approval by Principal Investigator, Prof Marie Yap -
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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