Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000266662
Ethics application status
Approved
Date submitted
28/02/2023
Date registered
13/03/2023
Date last updated
23/02/2024
Date data sharing statement initially provided
13/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the acceptability, feasibility, and short-term effects of a coach-supported, online parenting program (‘PiP-SP+’) to empower parents whose adolescents have suicidal thoughts and/or behaviours.
Scientific title
An open-label, uncontrolled trial of a therapist-assisted, online parenting program (‘PiP-Suicide Prevention’) to empower parents to support their adolescent who have suicidal thoughts and/or behaviours.
Secondary ID [1] 309097 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent suicide risk 329171 0
Adolescent anxiety 329172 0
Adolescent depression 329173 0
Condition category
Condition code
Public Health 326142 326142 0 0
Health promotion/education
Mental Health 326143 326143 0 0
Suicide
Mental Health 326144 326144 0 0
Anxiety
Mental Health 326145 326145 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, ‘Partners in Parenting-Suicide Prevention’ (PiP-SP+), is a newly adapted version of the Partners in Parenting-Plus (PiP+) program (formerly known as Therapist-Assisted Online Parenting Strategies [TOPS] - refer to ACTRN12618000290291). The original PiP+ program is an online parenting program designed to equip parents with evidence-based parenting strategies to respond to anxiety or depression in their 12-18-year-old adolescent. PiP-SP+ has been adapted to empower parents to support their adolescent who have suicidal thoughts and/or behaviours.


The PiP-SP+ 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 13 web-based modules); and,
2) a coaching component (refer to ACTRN12618000290291) delivered via videoconference, henceforth referred to as ‘coaching sessions’.


The web-based program includes 13 self-directed online modules covering topics related to parenting an adolescent who have suicidal thoughts and/or behaviours in the context of anxiety and/or depression: 1) understanding anxiety and depression, 2) parent-teen relationships, 3) talking about suicide and responding to suicide risk, 4) managing ongoing suicide risk, 5) understanding non-suicidal self-injury, 6) establishing family rules, 7) problem-solving, 8) minimising conflict, 9) breaking the anxiety cycle, 10) parental involvement and autonomy granting, 11) encouraging supportive relationship, 12) encouraging good habits, 13) relapse prevention.




The coaching component involves parents attending up to 9 sessions, of which the first includes an orientation component before educational materials. The coaching will be held with a PiP-SP+ coach via videoconference. The aim of the orientation component is to discuss the program objectives and boundaries with the parent, build rapport, conduct an initial assessment of the parent and teen’s situation, and collaboratively decide the order of the remaining coaching session topics. PiP-SP+ coaches are provisional psychologists completing a PhD (Clinical Psychology) at Monash University or registered psychologists. All coaches will receive an intensive training program which will include online learning materials and live and/or recorded role-play exercises with feedback. Additionally, coaches will be provided with ongoing support and development through regular supervision with a registered clinical psychologist (frequency dependant on coach level of training, e.g. weekly for provisional psychologists, fortnightly for registered psychologists). Each session takes approximately 50-60 minutes. Parents will be encouraged to complete coaching sessions weekly. Coaching sessions are manualised to ensure standardised delivery of the intervention.


Parents will receive the following as part of the PiP-SP+ 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-based 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 original PiP+ 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 further development. The feedback report is displayed to parents online (on their 'personal dashboard' as part of the PiP-SP+ program). Parents are also emailed a link to access a PDF copy of the Guidelines.


3) Parents will receive at least 5 core modules but are recommended up to 13 interactive online modules.
All parents in the current trial will receive the following core modules, as these are considered the most important topics for parents of adolescents who have increased suicide risk: 1) understanding anxiety and depression, 2) parent-teen relationships), 3) talking about suicide and responding to suicide risk, 4) managing ongoing suicide risk, 5) relapse prevention. Additionally, all parents will be recommended the non-suicidal self-injury module, however selection of this module will remain optional.
The remaining modules will be recommended based on each parent’s identified areas for further development (PRADAS scores), but remain optional.
The modules provide practical strategies to support parents to make changes to their parenting to align more closely with the parenting recommendations in the Guidelines, and evidence-based content curated to support adolescents who have suicidal thoughts/behaviours and non-suicidal self-injury (NSSI). Parents can further tailor their program by selecting additional modules or de-selecting optional modules recommended to them. Therefore in addition to the 5 core modules, parents can select up to 8 other online modules to add to 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 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 about 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) Parents will receive coaching sessions with a PiP coach via video-conference. After completing each selected online module, parents will attend a coaching session associated with the completed module content. Parents will have a maximum of 14 weeks to complete a maximum of 9 coaching sessions and will be encouraged to attend weekly. The nine topics which include offer both coaching session and associated modules are: 1) understanding anxiety and depression, 2) parent-teen relationships), 3) talking about suicide and responding to suicide risk, 4) managing ongoing suicide risk, 5) relapse prevention, with the option of additional coaching sessions to include 6) understanding non-suicidal self-injury, 7) problem-solving, 8) minimising conflict, and 9) parental involvement and autonomy granting.


In each session parents will be guided by their coach through a check-in, a review of the online-module content, completion of an activity, and a goal-setting exercise, with a view to work towards their selected goal between sessions. Post-session, parents will have access to a collaborative coach-parent document housed on Google Documents (accessible via a unique URL sent via email), akin to a guided reflection, learning record, and summary page. Additionally, the collaborative coach-parent document will include a personalised tool to help parents to respond to their teen’s risk of NSSI or suicide.


Intervention adherence will be monitored through website analytics (module completion) and attendance records (coaching sessions).


Note. Adolescents will not participate in coaching sessions or have access to the modules. The intervention period is anticipated to run for 4 months while the adolescent continues to receive standard external psychological care.


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.
Intervention code [1] 325544 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334019 0
Parental self-efficacy about responding to adolescent suicidal thoughts/behaviours (quantitative).


The primary outcome will be measured using the total score of an adapted version of the Parental Self-Efficacy to Support Teens During a Suicidal Crisis and Future Adolescent Emergency Department Visits and Suicide Attempts (Czyz et al., 2018).

Adaptations include: (i) using neutral gender terms (they/their/them as opposed to he/him or she/her), (ii) the removal of the item “obtain a commitment from your child not to attempt suicide, (iii) the removal of the item “how confident are you that your child will NOT attempt suicide in the future?”
Therefore, a total of 10 items are included.

Answer choices range from 0 (not at all confident) to 10 (completely confident) with an anchor of 5 (somewhat confident). Scores of individual items will be summed to provide an overall measure of the parent’s self-efficacy to support their adolescent in suicide prevention behaviours. Scores can range from 0 to 100.
Timepoint [1] 334019 0
1) Pre-intervention (baseline survey package).
2) Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [1] 419091 0
Intervention acceptability (quantitative).
Program acceptability will be conceptualised as satisfaction with the intervention and measured using the Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). Scores of individual items in the CSQ-8 will be summed to yield a global rating of program satisfaction for each participant. Scores range from 8 to 32, with higher values indicating higher satisfaction (acceptability).


Reference:
Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., and Nguyen, T.D. (1979). Assessment of client/patient satisfaction: Development of a general scale, Evaluation and Program Planning, 2, 197-207.
Timepoint [1] 419091 0
Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [2] 419092 0
Module program completion percentage (quantitative):

Program completion will be measured as the percentage of selected online modules completed by parents. Module completion will be defined as viewing at least 80% of the module pages and selecting a goal.
Module program completion percentage will be used as indicators of program feasibility. Only the 9 topics which include both online modules and corresponding coaching sessions in this trial will be included in program completion calculations. Percentages will be calculated individually for online modules and coaching sessions, as: 100% x [(observed usage of the program] / (intended usage of the program)].


Observed usage = total number of [modules] completed by parent, as determined by website analytics (modules).
Intended usage = total number of [modules selected by parent, as determined by website analytics.
Timepoint [2] 419092 0
Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [3] 419093 0
Program adherence (quantitative)

Program adherence will be defined as the percentage of participants from the overall sample who complete the core program (the 5 required online modules and 6 coaching sessions). Program adherence will be calculated as a percentage, as defined by: 100% x [(number of participants who completed the required 5 online modules and 6 coaching sessions) / (total number of participants who received the intervention)].
Timepoint [3] 419093 0
Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [4] 419094 0
Parental self-efficacy about responding to adolescent NSSI (quantitative).

Changes to parent’s self-efficacy in responding to adolescent NSSI will be measured by parent self-report, consisting of 5 item:
1. Ask your child if they are experiencing thoughts of self-injury or have self-injured
2. Respond in a helpful manner if your child discloses self-injury
3. Identify indicators or signs of self-injury in your child?
4. If your child has thoughts of injuring themselves in the future, how confident are you that they will tell you?
5. If your child has thoughts of injuring themselves in the future, how confident are you that you can reduce their risk of self-injury?


Answer choices range from 0 (not at all confident) to 10 (completely confident) with an anchor of 5 (somewhat confident). Scores of individual items will be summed to provide a overall measure of the parent’s self-efficacy to support their adolescent in suicide prevention to NSSI behaviour. Scores can range from 0 to 50. The scale was developed for use in this trial.
Timepoint [4] 419094 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [5] 419095 0
Risk and protective factors for adolescent depression and anxiety disorders that parents can potentially modify (quantitative) 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).


The PRADAS is a composite measure of several risk and protective factors, hence the total score is the outcome of interest. Higher scores indicate higher levels of concordance with the Guidelines.
Timepoint [5] 419095 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [6] 419096 0
Parental self-efficacy for reducing the risk of adolescent depression and anxiety (quantitative)

Parents’ self-efficacy in their ability to engage in behaviours that can reduce the risk 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).


References:
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.
Timepoint [6] 419096 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [7] 419097 0
Carer burden (quantitative)

Changes to carer burden experienced by the parent as objective or subjective consequences, as measured by the Burden Assessment Scale (BAS; Reinhard & Horwitz, 1992).
The BAS contains 19 items; 10 items assess objective (observable) burden including financial problems or distress, limitations to social interaction and personal activity; 9 items measure subjective feelings, attitudes, and emotions expressed about the caregiving experiences. Items are scored on 4-point Likert scale and summed to obtain an overall score ranging from 19 to 76, with higher scores indicating greater levels of burden.


References:
Reinhard, S. C., Gubman, G. D., Horwitz, A. V., & Minsky, S. (1994). Burden assessment scale for families of the seriously mentally ill. Evaluation and program planning, 17(3), 261-269.
Timepoint [7] 419097 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [8] 419098 0
Parent Psychological Distress (quantitative)

Changes to distress experienced by the parent will be measured by the total score of the Kessler-6 scale (K6; Kessler et al., 2003). The K6 contains 6 items, items are scored on a 5-point Likert scale and summed to obtain an overall score ranging from 6 to 30, with higher scores indicating greater levels of psychological distress.


Reference:
Kessler, R.C., Barker, P.R., Colpe, L.J., Epstein, J.F., Gfroerer, J.C., Hiripi, E., Howes, M.J, Normand, S-L.T., Manderscheid, R.W., Walters, E.E., Zaslavsky, A.M. (2003). Screening for serious mental illness in the general population. Archives of General Psychiatry, 60(2), 184-189.
Timepoint [8] 419098 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [9] 419099 0
Family Functioning (quantitative)

Changes to general family functioning will be measured by the General Functioning subscale of the McMaster Family Assessment Device (FAD-GF) as reported by the parent.


The FAD-GF is a 12-item subscale that measures general functioning of the family across the six dimensions of the McMaster Model of family functioning (Epstein, Baldwin, & Bishop, 1983). Participants use a 4-point response scale (strongly agree, agree, disagree and strongly disagree) to describe how well each statement describes their family. The mean score of the 14 items is calculated, after reversing scores for negatively worded items to give an overall scale score of 1 (best functioning) to 4 (worse functioning). Scores range from 12-48.


References:
Epstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster family assessment device. Journal of marital and family therapy, 9(2), 171-180.
Timepoint [9] 419099 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [10] 419100 0
Quality of Mental Health Support (quantitative)

Changes to quality of mental health support which parents intend to provide to their adolescent will be measured by items of the Mental Health Support Scale Intended (MHSS-I). All items will be used excluding 3 items on the psychotic symptoms subscale and 2 items on the reluctance to seek help subscale, totalling 18 items.
Answer choices range from Very unlikely (1), Unlikely (2), Neither likely nor unlikely (3), Likely (4), Very likely (5). Scores of individual items will be summed to provide a global rating of quality of mental health support parents intend to provide, with scores ranging from 18 to 90.


References:
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
Timepoint [10] 419100 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [11] 419101 0
Adolescent anxiety symptoms reported by parent report (quantitative)


Changes to adolescent anxiety symptoms will be reported by the parents via the 25-item Revised Child Anxiety and Depression Scale-Parent report (RCADS-25-Parent report; Ebesitani et al., 2017). A global anxiety symptom score will be obtained by totalling the 15 anxiety disorder items. Item scores range from 0 to 3, and will be summed to yield a global anxiety symptom severity ranging from 0 to 45.


References:
Ebesitani, C., Korathu-Larson, P., Nakamura, B., Higa-McMillan, C., & Chorpita, B. (2017). The Revised Child Anxiety and Depression Scale 25-Parent Version: Scale Development and Validation in a School-Based and Clinical Sample. Assessment, 24(6), 712-728.
Timepoint [11] 419101 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [12] 419102 0
Adolescent depressive symptoms by parent report (quantitative)


Changes to adolescent depressive symptoms will be reported by parents, via the 25-item Revised Child Anxiety and Depression Scale-Parent report (RCADS-25-Parent report; Ebesitani et al., 2017). An overall depression symptom score will be obtained by totalling the 10 depression items. Item scores range from 0 to 3, and will be summed to yield a global depression symptom severity ranging from 0 to 30.




References:
Ebesitani, C., Korathu-Larson, P., Nakamura, B., Higa-McMillan, C., & Chorpita, B. (2017). The Revised Child Anxiety and Depression Scale 25-Parent Version: Scale Development and Validation in a School-Based and Clinical Sample. Assessment, 24(6), 712-728.
Timepoint [12] 419102 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date
Secondary outcome [13] 419104 0
Perceived Parental Emotional Support if Suicidal or Self-Injuring (quantitative)

Changes to perceived parental emotional support will be measured by adolescent self-report. This scale consists of 4 items designed to measure adolescent’s perception of parental emotional support if they were suicidal or self-injuring. Items included are:
1. If I had thoughts of killing myself, I would feel comfortable talking to my [mum/dad] about it
2. If I had thoughts of hurting myself on purpose, I would feel comfortable talking to my [mum/dad] about it
3. If I had thoughts of killing myself, my [mum/dad] would provide the emotional support I need
4. If I had thoughts of hurting myself on purpose, my [mum/dad] would provide the emotional support I need

Responses are indicated on a four-point Likert scale (0 = ‘Strongly disagree’, 1 = ‘Disagree’, 2 = ‘Neither agree nor disagree’, 3 = ‘Agree’, 4= ‘Strongly agree’. The scores will be summed to form a total score from 0 to 16. Higher scores indicate greater perceived parental emotional support. The scale was developed for use in this trial.
Timepoint [13] 419104 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [14] 419105 0
Validity of the intervention (qualitative)

Validity of the intervention will be assessed, that is, parents’ perception of whether the program design features (such as program content, delivery, software, and features) improved parents’ self-efficacy to respond to their adolescent’s suicidal thoughts/behaviours and self-injury. The validity of the intervention will be explored in a semi-structured qualitative interview with parents. The interview will be semi-structured, one-on-one, and occur via videoconferencing with a member of the research team who was not the coach of the interviewed parent.
Timepoint [14] 419105 0
Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [15] 419106 0
Intervention acceptability (qualitative).

Acceptability of the intervention to parents will be assessed qualitatively via semi-structured interviews. All parents who participated will be invited to the semi-structured interview. Parent interview schedules will be based on items included in the Theoretical Framework of Acceptability (TFA) questionnaire (Sekhon et al. 2022) and theories which have informed the PiP-SP+ intervention design (e.g., the supportive accountability model and persuasive system design model; Mohr et al., 2011; Oinas-Kukkonen, H., & Harjumaa, M., 2009; Yap et al., 2017). The generic version of the questionnaire items was designed to be tailored to the specific intervention being evaluated. Each item in the questionnaire assesses a theory-informed domain of program acceptability (Sekhon et al., 2017). Interviews will be conducted with parents to understand how acceptable the program was to receive, and how the acceptability of the intervention could be enhanced.


Additionally, acceptability of the intervention to both parents and adolescents will be assessed via an open-text question in the post-intervention survey package for both adolescent and parent participants. The post-intervention survey for parents will include an open-text field for parents to provide written feedback via the question “Do you have any other comments or suggestions to improve the PiP-SP+ program? We welcome any feedback.” Additionally, the post-intervention survey for adolescents will include an open-text field for adolescents to provide written feedback via the question “Do you have any comments or suggestions about the PiP-SP+ program and any changes you may have noticed in your parent or your relationship with them? We welcome any feedback."

References:
Mohr, D., Cuijpers, P., & Lehman, K. (2011). Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions. Journal of medical Internet research, 13(1), e1602.

Oinas-Kukkonen, H., & Harjumaa, M. (2009). Persuasive systems design: Key issues, process model, and system features. Communications of the association for Information Systems, 24(1), 28.

Sekhon, M., Cartwright, M., Francis, J. J. (2022). Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Services Research, 22(279). https://doi.org/10.1186/s12913-022-07577-3.

Sekhon, M., Cartwright, M., & Francis, J. J. (2017). Acceptability of healthcare interventions: An overview of reviews and development of a theoretical framework. BMC Health Services Research, 17(1). https://doi.org/10.1186/s12913-017-2031-8

Yap, M. B., Lawrence, K. A., Rapee, R. M., Cardamone-Breen, M. C., Green, J., & Jorm, A. F.. (2017). Partners in Parenting: A Multi-Level Web-Based Approach to Support Parents in Prevention and Early Intervention for Adolescent Depression and Anxiety. JMIR Mental Health, 4(4), e59. https://doi.org/10.2196/mental.8492
Timepoint [15] 419106 0
Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [16] 419429 0
Coaching program completion percentage (quantitative):

Coaching program completion will be measured as the percentage of coaching sessions completed by parents.
Coaching program completion percentages will be used as indicators of program feasibility. Only the 9 topics which include both online modules and corresponding coaching sessions in this trial will be included in program completion calculations. Percentages will be calculated individually for coaching sessions, as: 100% x [(observed usage of the program] / (intended usage of the program)].


Observed usage = total number of coaching sessions completed by parent, as determined by audit of session attendance records (coaching sessions).
Intended usage = total number of coaching sessions selected by parent, as determined by audit of sessions scheduled (coaching sessions).
Timepoint [16] 419429 0
Post-intervention: 4-months (120 days) from parent baseline completion date.
Secondary outcome [17] 419431 0
Adolescent anxiety symptoms reported by adolescent report (quantitative)


Changes to adolescent anxiety symptoms will be reported by adolescents, via the 25-item Revised Child Anxiety and Depression Scale (RCADS-25 Ebesutani et al., 2012). A global anxiety symptom score will be obtained by totalling the 15 anxiety disorder items. Item scores range from 0 to 3, and will be summed to yield a global anxiety symptom severity ranging from 0 to 45.


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, 833–45
Timepoint [17] 419431 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date
Secondary outcome [18] 419432 0
Adolescent depressive symptoms by adolescent report (quantitative)


Changes to adolescent depressive symptoms will be reported by adolescent, via the 25-item Revised Child Anxiety and Depression Scale (RCADS-25; Ebesitani et al., 2012). An overall depression symptom score will be obtained by totalling the 10 depression items. Item scores range from 0 to 3, and will be summed to yield a global depression symptom severity ranging from 0 to 30.




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, 833–45
Timepoint [18] 419432 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 4-months (120 days) from parent baseline completion date

Eligibility
Key inclusion criteria
Group 1: Parents and/or guardians:
- of adolescents aged 12-18 years
- who are concerned about their adolescent's suicidal thoughts and/or behaviours
- whose adolescents are currently engaged with a health professional for treatment of mental health problems (i.e., depression or anxiety). For the purposes of this trial, a health professional is a treating health professional in which the adolescent can seek mental health support from if the adolescent experiences deterioration in their mental health.
- live in Australia
- can read, write, speak, and communicate in spoken English
- Have regular access to the Internet, a telephone, and email.


Group 2: Adolescents (aged 12-18 years) who:
- are the identified adolescent of the parent participant
- are currently engaged with a health professional for treatment and support of mental health problems (i.e., depression or anxiety)
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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. acute mental health crisis, recent suicide attempt or inpatient treatment) will not be eligible to participate in the trial.

2. Parents whose adolescent is engaged in treatment that involves parenting work or family therapy.


3. Parents whose adolescent is not currently engaged with a health professional for treatment of their mental health problem.

Group 2: Adolescents (12-18 years)
There are no additional exclusion criteria beyond the above mentioned criteria for parents. All adolescents of eligible parents will be eligible to participate.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Group 1: Parents
A sample size of 15-18 parents will be recruited to receive the intervention. A sample size of 10 has been found to be appropriate for pilot studies estimating sample size (Birkett & Day, 1994) and is in alignment with guidance for evaluating interventions published by the Medical Research Council (Craig et al., 2008). The recruitment of 15-18 parent-adolescent dyads will account for the anticipated lower rates of adolescent participants (i.e. given that parents can participate without their adolescent also participating), and will allow for at least 50% attrition.

To assess short-term effects in primary and secondary outcomes, paired samples t-tests or appropriate non-parametric tests will be conducted for each measure (Adapted Parental Self-Efficacy to Support Teens During a Suicidal Crisis and Future Adolescent Emergency Department Visits and Suicide Attempts Scale, PRADAS, PSES, BAS, K6, RCADS-P-25, RCADS-P-25 anxiety subscale, RCADS-P-25 depression subscale, FAD - General Functioning Subscale, MHSS-I).


Analysis of quantitative program acceptability and feasibility outcomes will be largely descriptive. Program acceptability will be measured qualitatively and quantitatively. Qualitative data will be collected via semi-structured interviews for parents pertaining to program acceptability, feasibility, and validity. The qualitative data will be then analysed with thematic analysis, adhering to the 6 phases outlined by Braun & Clarke (2006) with themes identified deductively against Theoretical Framework of Acceptability (TFA) questionnaire (Sekhon et al. 2022) and theories which have informed the PiP-SP+ intervention design (e.g., the supportive accountability model and persuasive system design model; Mohr et al., 2011; Oinas-Kukkonen, H., & Harjumaa, M., 2009; Yap et al., 2017).


Quantitative program feasibility outcomes will be calculated as percentages (e.g., percentages of required online modules and coaching sessions completed, percentage of the sample who adhered to program requirements) at 4-months post intervention commencement.


Group 2: Adolescents
A sample of up to 18 adolescents of participating parents will be recruited to assess short-term effects related to adolescent outcomes, namely adolescent anxiety symptoms, depressive symptoms, and perceived parental emotional support regarding suicidality and NSSI. To assess short-term effects of adolescent-report secondary outcomes, paired samples t-tests (or single factor repeated measures mixed model ANOVA depending on amount of missing data) will be conducted between pre- and post-intervention scores (RCADS-25 anxiety subscale, RCADS-25 depression subscale, Perceived parental emotional support).


Additionally, qualitative responses to open-text questions for both parent and adolescent post-intervention surveys will be analysed with qualitative content analysis (Stemler, 2001).

References:


Birkett, M. A., & Day, S. J. (1994). Internal pilot studies for estimating sample size. Statistics in Medicine, 13, p2455-2463.


Braun, V. & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101.


Craig, P., Dieppe, P., Macintyre, S., Michie, S., Nazareth, I., & Petticrew, M. (2008). Developing and evaluating complex interventions: The new Medical Research Council guidance. BMJ, a1655. https://doi.org/10.1136/bmj.a1655


Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., and Nguyen, T.D. (1979). Assessment of client/patient satisfaction: Development of a general scale, Evaluation and Program Planning, 2, 197-207.


Sekhon, M., Cartwright, M., & Francis, J. J. (2017). Acceptability of healthcare interventions: An overview of reviews and development of a theoretical framework. BMC Health Services Research, 17(1). https://doi.org/10.1186/s12913-017-2031-8


Stemler, S. E. (2001). An overview of content analysis. Practical Assessment, Research, and Evaluation, 7(17). Retrieved from http://pareonline.net/getvn.asp?v=7&n=17.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2023
Actual
7/04/2023
Date of last participant enrolment
Anticipated
28/07/2023
Actual
24/08/2023
Date of last data collection
Anticipated
31/12/2023
Actual
18/01/2024
Sample size
Target
36
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313301 0
Charities/Societies/Foundations
Name [1] 313301 0
Suicide Prevention Australia
Country [1] 313301 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk Clayton Campus, Clayton VIC 3800 Australia
Country
Australia
Secondary sponsor category [1] 315042 0
None
Name [1] 315042 0
Address [1] 315042 0
Country [1] 315042 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312526 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 312526 0
Ethics committee country [1] 312526 0
Australia
Date submitted for ethics approval [1] 312526 0
Approval date [1] 312526 0
27/02/2023
Ethics approval number [1] 312526 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124978 0
A/Prof Marie Yap
Address 124978 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 124978 0
Australia
Phone 124978 0
+61 3 9905 0723
Fax 124978 0
Email 124978 0
marie.yap@monash.edu
Contact person for public queries
Name 124979 0
Alice Cao
Address 124979 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 124979 0
Australia
Phone 124979 0
+61 3 9903 4042
Fax 124979 0
Email 124979 0
alice.cao@monash.edu
Contact person for scientific queries
Name 124980 0
Marie Yap
Address 124980 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 124980 0
Australia
Phone 124980 0
+61 3 9905 0723
Fax 124980 0
Email 124980 0
marie.yap@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Unable to share individual participant data due to the small sample, and privacy and confidentiality reasons per ethics application. Participants have only consented to data being deidentified and aggregated if disseminated to the public. Individual data will only be available to personnel who have been approved on the ethics application for this trial.


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.