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Trial registered on ANZCTR


Registration number
ACTRN12618000290291
Ethics application status
Approved
Date submitted
6/02/2018
Date registered
26/02/2018
Date last updated
20/03/2020
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Therapist-assisted Online Parenting Strategies (TOPS) program on anxiety, depression and sleep in adolescents aged 12 to 18 years.
Scientific title
Effects of an online parenting program with telephone coaching (Therapist-assisted Online Parenting Strategies) on anxiety, depression and sleep outcomes of 12-18 year-olds with anxiety and depression: A single-armed uncontrolled open-label trial.
Secondary ID [1] 293566 0
NIL
Universal Trial Number (UTN)
U1111-1206-3980
Trial acronym
Linked study record
ACTRN12615000247572

Health condition
Health condition(s) or problem(s) studied:
Anxiety 305798 0
Depression 305799 0
Sleep problems 306193 0
Suicidal ideation 306302 0
Condition category
Condition code
Mental Health 305017 305017 0 0
Anxiety
Mental Health 305018 305018 0 0
Depression
Public Health 305382 305382 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This individualized intervention is comprised of two parts:
1) a web-based component drawn from the Partners in Parenting intervention (refer to ACTRN12615000247572) which includes a once-off individually-tailored feedback report on the parent's parenting practices and up to nine weekly web-based modules (each taking 15-25 minutes to complete); and, 2) a coaching component delivered via web-conference or telephone, henceforth known as Therapist-assisted Online Parenting Strategies (TOPS) sessions, one session accompanying each web-based module, each taking 30-45 minutes.

The web-based component will be composed of 9-modules, covering areas of 1) the parent’s relationship with their teen, 2) parental involvement, 3) encouraging their teen to develop supportive relationships with friends, 4) establishing family rules, 5) minimising conflict in the home environment, 6) health habits covering diet, physical activity, sleep habits and abstinence from alcohol and drugs, 7) strategies for parents to help deal with their teen’s problems, 8) strategies for parents to help their teen manage their anxiety, and 9) seeking additional professional help.

Supplemented TOPS sessions will be run in the trial, aligned with material from the Partners in Parenting program. The TOPS sessions contain more expansive content for parents to reinforce learning and allow them the opportunity to clarify the material provided on the website. Discussions around goal setting and enabling goal attainment are also a focus of these sessions. The material developed to enhance the online-content is visually presented through online teleconferencing during the TOPS coaching session. Annotated copies of the presentation will be provided as soft-copy and emailed to the parent at the end of the TOPS session. TOPS sessions are manualised so that coaches standardize delivery of the protocol. TOPS coaches are at minimum post-graduate psychology students undertaking training in a Doctorate or Masters in Psychology (Clinical or Educational and Developmental).

Parents will first complete two baseline surveys of the Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS; Cardamone-Breen, Jorm, Lawrence, Mackinnon, & Yap, 2017) that assesses their current parenting practices against the recommendations in the Guidelines 'How to reduce your child's risk of depression and clinical anxiety in your teenager' (Yap, Martin, & Jorm, 2017; henceforth the Guidelines). Based on their responses to the second baseline survey that is completed approximately 1 month after registration, parents in the intervention group will then (1) receive an individually-tailored feedback report that highlights areas where they are doing well (i.e., concordant with the Guidelines) and areas where they can improve (i.e., not concordant with the Guidelines), and (2) be given access to the web-based parenting intervention (up to 9 modules) to support them in making changes to the identified areas of weakness in their parenting. Specific modules are recommended to parents based on their responses to the Parent Survey. Feedback messages will be brief, with practical strategies provided in dot point form, and are designed to motivate behaviour change. All participating parents will view their feedback report online and will also be emailed a copy of their feedback report.

The participating parent will be invited to attend an orientation session within 1 month of registering but prior to completion of the second baseline survey. This session is aimed at enabling the parent participant to log-in to the intervention website, to engage with the online modules and to become familiarised with the web-conference coaching process. No intervention material or psychoeducation content will be presented to participants at this stage.

Immediately after the parent participant completes the second baseline survey, he/she will be emailed instructions for accessing the interactive parenting program. When parents log in to their parenting program, he/she will see their recommended modules as well as the remaining modules that have not been allocated. Parents can further tailor their parenting program at this stage by deselecting recommended modules and/or selecting additional modules. They then confirm their selection and can commence their personalised program.

The 9 modules comprising the intervention are derived from topics covered in the Guidelines. Modules include illustrations, vignettes, interactive activities, goal-setting exercises, and an end-of-module quiz with immediate feedback to consolidate learning. The module topics include:
1) Establishing and maintaining a good relationship with your teenager
2) Being involved and supporting increasing autonomy
3) Encouraging supportive relationships
4) Establishing family rules and consequences
5) Minimising conflict in the home
6) Encouraging good health habits (diet, physical activity, sleep and abstinence from alcohol or drugs)
7) Helping your teenager to deal with problems
8) Helping your teenager to deal with anxiety
9) Professional help-seeking when needed

Trained coaches will unlock online modules progressively for parents after they have completed the previous module and received a follow-up TOPS coaching session at a time appointed by the parent. Online modules will take approximately 15 to 25 minutes to complete while the conference call-coaching sessions are anticipated to take between 30 and 45 minutes. TOPS-coaches will review goal setting or the successful application of new skills, respond to questions, and provide encouragement. Adolescents will not participate in coaching calls or access the website. The intervention period is anticipated to run for 4 months while the adolescent continues to receive standard psychological care externally. Although the online component consists of only 9-modules, up to 13 telephone coaching sessions will be offered to parents through an expanded "Encouraging good health habits" module, covering each health habit of diet, physical activity, sleep and abstinence from alcohol or drugs, over 4 weeks. Parents are encouraged to complete one module per week. Once parents have completed all the modules in their personalised program, they have ongoing access to all 12 modules in the program. Their access to their parenting program will remain open indefinitely.

Retention of participants will be aided by follow-up phone calls to parents who have not booked in their TOPS session within a 2-week period. Trained research assistants with currently enrolment status in an undergraduate degree majoring in Psychology will follow-up calls using a standardised script.

Outcomes will be assessed through parent and adolescent online surveys completed at the two baseline timepoints (at enrolment, Day 0; and on Day 30), at post-intervention (4 months from the parent commencing the intervention) and at follow-up (12 months from the parent commencing the intervention).

Consent for adolescent participation will be provided by parents during registration or if adolescents turn 18 during the trial, consent will be obtained from the teen separately prior to their continued participation in the trial. Research assistants will then contact adolescents by phone to initiate completion of the adolescent-version surveys where they will be provided with separate logins and passwords. Adolescents will be guided through using Qualtrics to complete the survey and encouraged to complete this survey (except for the sleep diary component) in one sitting. Where they are unable to do so in one sitting, reminder emails or SMS will be sent to the adolescent, if required follow-up by another phone call within a 7-day period. At all time points, adolescents will be requested to complete the survey (or opt out of doing so if they do not wish to participate) before the parents are asked to do the same, with a maximum period of a one-week difference allowed between parent and adolescent survey completion.

References:
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.

Yap, M. B. H., Martin, P. D., & Jorm, A. F. (2017). Online parenting guidelines to prevent adolescent depression and anxiety: Evaluating user characteristics and usefulness. Early Intervention in Psychiatry.
Intervention code [1] 299810 0
Lifestyle
Intervention code [2] 299811 0
Behaviour
Intervention code [3] 299812 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304182 0
Change in parental concordance with the Parenting Guidelines scores measured by parent-report on the Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS) from baseline to post-intervention, and follow-up. The survey consists of 83 questions and is a criterion-referenced measure assessing parents' current parenting knowledge and behaviours against specific recommendations in the Guidelines.

References:
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.
Timepoint [1] 304182 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention; primary timepoint)
4) 12-months from the intervention commencement date (Follow-up)
Primary outcome [2] 304553 0
Adolescent depression

Change in depression levels measured by total scores on adolescent-report version of the 13-item Short Mood and Feelings Questionnaire (SMFQ; Angold, Costello, Messer, & Pickles, 1995). Items are based on the respondents' experiences in the past two weeks, scored on a scale of 0 to 2, “not true”, “sometimes” and “always” respectively. The total score is the sum of all 13 items. Higher scores indicate higher levels of depressive symptoms.

Reference:
Angold, A., Costello, E. J., Messer, S. C., & Pickles, A. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. International Journal of Methods in Psychiatric Research, 5(4), 237-249.

Timepoint [2] 304553 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up; primary timepoint)
Primary outcome [3] 304554 0
Adolescent Anxiety
Changes in anxiety levels measured by adolescent-report version of the Spence Children's Anxiety Scale (SCAS). The SCAS (Spence, 1998) is a 44-item questionnaire that measures anxiety symptoms across 6 disorders described in the DSM-IV-TR (American Psychiatric Association, 2000); generalised anxiety disorder (6 items; e.g. “I worry about things”); separation anxiety disorder (6 items; e.g. “I would feel afraid of being on my own at home”); social phobia (6 items; e.g. “I worry what other people think of me”); panic disorder and agoraphobia (9 items; “I suddenly feel as if I can’t breathe when there is no reason for this”); and, obsessive-compulsive disorder (6 items; e.g. “I have to think of special thoughts to stop bad things from happening (like numbers or words)”). Fear of physical injury replaces specific phobias in this questionnaire and is composed of 5 items, e.g. “I am scared of dogs”. Six remaining items do not contribute to overall scoring, and serve as fillers to reduce negative response bias. Items are scored on a scale of 0 to 3; “never”, “sometimes”, “often”, or “always” respectively. Sum scores of relevant items form individual subscale scores and a total anxiety score is computed by summing all items in the questionnaire (range = [0, 114]). Higher scores indicate higher levels of anxiety.

Reference:
Spence, S. H. (1998). A measure of anxiety symptoms among children. Behaviour Research And Therapy, 36(5), 545-566. doi:10.1016/S0005-7967(98)00034-5
Timepoint [3] 304554 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up; primary timepoint)
Secondary outcome [1] 341153 0
Changes to carer burden experienced by the parent as objective or subjective consequences, through the Burden of 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 [1] 341153 0
1) At recruitment (Baseline 1)
2) 1 month after recruitment (Baseline 2)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [2] 341155 0
Changes to general family functioning will be measured by the General Functioning subscale of the McMaster Family Assessment Device (FAD-GF), reported independently by parent and adolescent.

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).

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 [2] 341155 0
1) At recruitment (Baseline 1)
2) 1 month after recruitment (Baseline 2)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [3] 341156 0
Changes to parent-adolescent attachment measured by the Inventory of Parent and Peer Attachment (IPPA) across three domains; mutual trust, communication quality and extent of relationship alienation (Armsden & Greenberg, 1987). Only the parent-attachment section of the survey will be completed, with reports from both parent and adolescent.

Subscales for the three domains are calculated by summing the domain-relevant items, after reversing scores for negatively worded statements. The total score for the parent attachment scale is calculated by adding the trust and communication subscale scores and then subtracting the alienation subscale score, with higher scores indicating higher attachment security.

Armsden, G. C., & Greenberg, M. T. (1987). The Inventory of Parent and Peer Attachment: Individual differences and their relationship to psychological well-being in adolescence. Journal of Youth and Adolescence, 16(5), 427-454.
Timepoint [3] 341156 0
1) At recruitment (Baseline 1)
2) 1 month after recruitment (Baseline 2)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [4] 341157 0
Changes to the quality of sleep measured by adolescent report of the PROMIS® Pediatric Sleep Disturbance SF-8 (PROMIS-D).

The PROMIS-D assesses perceptions of sleep quality, sleep depth and restoration associated with sleep, over the past 7 days. It consists of 8 items, is non-disease specific and only assesses for sleep quality outcomes. Items are scored on a Likert scale of 1 (never) to 5 (always) except for one item, “I slept through the night”, which is reversed scored. The total raw scores are calculated for each measure and converted to a T-score (M=50, SD =10) using a table of normed scores (Meltzer, personal communication, July 7, 2017).
Timepoint [4] 341157 0
1) At recruitment (Baseline 1)
2) 1 month after recruitment (Baseline 2)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [5] 341158 0
Changes to sleep hygiene or sleep practices known to affect the quality of sleep measured by adolescent report of a modified PROMIS® Pediatric Sleep Practices (PROMIS-P). Seven questions around bedtime regulation and use of technology before bed are asked; all items unrelated to bedtime regulation scored on a 5-point Likert scale of 1 (never) to 5 (always) and items related to bedtime regulation are reversed scored.

To account for other known sleep hygiene factors associated with poor sleep, additional questions will be asked about caffeine, alcohol and medication use, as well as their napping practices. Scoring for these questions will initially be dichotomised 0 (No) and 1 (Yes). When all items are summed, higher scores indicate poorer sleep practices.

Timepoint [5] 341158 0
1) At recruitment (Baseline 1)
2) 1 month after recruitment (Baseline 2)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [6] 341276 0
Changes to chronotype or sleep phase measured by the Composite of Morningness scale as reported by adolescents (CSM).

The CSM consist of 13 questions to assess the individual’s optimal time-of-day functioning preferences for physical and mental activity, and subjective alertness; 3 items (1, 2 and 7) are scored on a scale of 1 to 5 with remaining questions scored from 1 to 4. All items except for 3, 4, 5 and 11 are reversed scored. Items are summed to give a total score ranging from 13 (extreme eveningness) to 55 (extreme morningness; Smith, Reilly, & Midkiff, 1989).

Reference:
Smith, C. S., Reilly, C., & Midkiff, K. (1989). Evaluation of three circadian rhythm questionnaires with suggestions for an improved measure of morningness. Journal of Applied Psychology, 74(5), 728-738. doi:10.1037/0021-9010.74.5.728
Timepoint [6] 341276 0
1) At recruitment (Baseline 1)
2) 1 month after recruitment (Baseline 2)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [7] 342259 0
Changes to adolescent self-report scores of the Suicidal Ideation Questionnaire-Junior High School Version (SIQ-JR). This is a 15 item self-report questionnaire designed to measure current suicidal ideation. The measure uses a seven-point scale, ranging from “I never had this thought” to “Almost every day”, to assess the frequency of suicidal thoughts. Scores range from 0 to 90 and a score of 31 or above has been found to be indicative of a significant level of suicidal ideation and worthy of further evaluation (Reynolds, 1988).

Reynolds, W. M. (1988). SIQ, Suicidal ideation questionnaire: Professional manual. Psychological Assessment Resources.
Timepoint [7] 342259 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [8] 342831 0
Changes to parent-reported scores of the Family Accommodation Scale for Anxiety (Lebowitz, et al., 2013). This is a 9-item questionnaire measuring the level of behavioural changes made by the parent to help their teen diminish or avoid the distress caused by a disorder. Items are coded on a 5-point Likert-type scale from 0 (Never) to 4 (Daily). The overall mean score is obtained from these responses, with higher scores indicating greater levels of accommodation made by the parent.

Lebowitz, E. R., Woolston, J., Bar-Haim, Y., Calvocoressi, L., Dauser, C., Warnick, E., ... & Vitulano, L. A. (2013). Family accommodation in pediatric anxiety disorders. Depression and Anxiety, 30(1), 47-54.
Timepoint [8] 342831 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [9] 343237 0
Sleep outcomes

Changes to weekday and weekend total sleep duration, sleep onset latency and sleep timing measured by adolescent-report from the Consensus Sleep Diary (CSD). This will be measured over 7 continuous days during the school-term. The CSD is composed of 9 items and requests participants over a minimum 1-week period to record daily their (1) time into bed, (2) time of sleep attempted, (3) time it took to fall asleep, (4) the number of night awakenings during the main sleep period, (5) total estimated duration of awakenings, (6) time of final awakening, (7) rise time, (8) subjective report of sleep quality, and (9) any other information pertaining to their sleep (e.g. medical condition) that night. Of these items, bedtimes and waketimes are taken directly from items 1 and 6 respectively while sleep onset latency (SOL) and wakefulness after sleep onset (WASO) is taken from items 3 and 5 respectively. Terminal wakefulness after sleep onset (TWASO) is calculated by subtracting time of final awakening (item 6) from rise time (item 7). This is then used to calculate the total wake time (TWT), which is the sum of SOL, WASO and TWASO. TIB is calculated by obtaining the difference between time into bed and rise time (item 1 and 7). Total sleep duration is then calculated by subtracting TWT from TIB.

References:
Carney, C. E., Buysse, D. J., Ancoli-Israel, S., Edinger, J. D., Krystal, A. D., Lichstein, K. L., & Morin, C. M. (2012). The consensus sleep diary: Standardizing prospective sleep self-monitoring. Sleep, 35(2), 287-302. doi:10.5665/sleep.1642
Timepoint [9] 343237 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [10] 343436 0
Changes to the quality of sleep measured by parent report of the PROMIS® Pediatric Sleep Disturbance SF-8 (PROMIS-D).

The PROMIS-D assesses perceptions of sleep quality, sleep depth and restoration associated with sleep over the past 7 days. It consists of 8 items, is non-disease specific and only assesses for sleep quality outcomes. Items are scored on a Likert scale of 1 (never) to 5 (always) except for one item, “I slept through the night”, which is reversed scored. The total raw scores are calculated for each measure and converted to a T-score (M=50, SD =10) using a table of normed scores (Meltzer, personal communication, July 7, 2017).
Timepoint [10] 343436 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [11] 343437 0
Changes to the quality of sleep measured by parent report of the PROMIS® Pediatric Sleep Related Impairment SF-8 (PROMIS®-RI).

The PROMIS-RI assesses perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness covering a period over the past 7 days. It consists of 8 items, is non-disease specific and only assesses for sleep quality outcomes. Items are scored on a Likert scale of 1 (never) to 5 (always). The total raw scores are calculated for each measure and converted to a T-score (M=50, SD =10) using a table of normed scores (Meltzer, personal communication, July 7, 2017).
Timepoint [11] 343437 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [12] 343438 0
Changes to the quality of sleep measured by adolescent report of the PROMIS® Pediatric Sleep Related Impairment SF-8 (PROMIS®-RI).

The PROMIS-RI assesses perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness covering a period over the past 7 days. It consists of 8 items, is non-disease specific and only assesses for sleep quality outcomes. Items are scored on a Likert scale of 1 (never) to 5 (always). The total raw scores are calculated for each measure and converted to a T-score (M=50, SD =10) using a table of normed scores (Meltzer, personal communication, July 7, 2017).
Timepoint [12] 343438 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [13] 343439 0
Changes to sleep hygiene or sleep practices known to affect the quality of sleep measured by parent report of a modified PROMIS® Pediatric Sleep Practices (PROMIS-P). Seven questions around bedtime regulation and use of technology before bed are asked; all items unrelated to bedtime regulation scored on a 5-point Likert scale of 1 (never) to 5 (always) and items related to bedtime regulation are reversed scored.

To account for other known sleep hygiene factors associated with poor sleep, additional questions will be asked about caffeine, alcohol and medication use, as well as their napping practices. Scoring for these questions will initially be dichotomised 0 (No) and 1 (Yes). When all items are summed, higher scores indicate poorer sleep practices.
Timepoint [13] 343439 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [14] 343440 0
Adolescent depression

Change in depression levels measured by total scores on parent report version of the 13-item Short Mood and Feelings Questionnaire (SMFQ; Angold, Costello, Messer, & Pickles, 1995). Items are based on the adolescent's experiences in the past two weeks, scored on a scale of 0 to 2, “not true”, “sometimes” and “always” respectively. The total score is the sum of all 13 items. Higher scores indicate higher levels of depressive symptoms.

Reference:
Angold, A., Costello, E. J., Messer, S. C., & Pickles, A. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. International Journal of Methods in Psychiatric Research, 5(4), 237-249.
Timepoint [14] 343440 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)
Secondary outcome [15] 343441 0
Adolescent Anxiety
Changes in anxiety levels measured by parent-report version of the Spence Children's Anxiety Scale (SCAS). The SCAS (Spence, 1998) is a 44-item questionnaire that measures anxiety symptoms across 6 disorders described in the DSM-IV-TR (American Psychiatric Association, 2000); generalised anxiety disorder (6 items; e.g. “My child worries about things”); separation anxiety disorder (6 items; e.g. “My child would feel afraid of being on his/her own at home”); social phobia (6 items; e.g. “My child worries what other people think of him/her”); panic disorder and agoraphobia (9 items; “My child suddenly feel as if he/she can’t breathe when there is no reason for this”); and, obsessive-compulsive disorder (6 items; e.g. “My child has to think of special thoughts (like numbers or words) to stop bad things from happening”). Fear of physical injury replaces specific phobias in this questionnaire and is composed of 5 items, e.g. “My child is scared of dogs”. Six remaining items do not contribute to overall scoring, and serve as fillers to reduce negative response bias. Items are scored on a scale of 0 to 3; “never”, “sometimes”, “often”, or “always” respectively. Sum scores of relevant items form individual subscale scores and a total anxiety score is computed by summing all items in the questionnaire (range = [0, 114]). Higher scores indicate higher levels of anxiety.

Reference:
Spence, S. H. (1998). A measure of anxiety symptoms among children. Behaviour Research And Therapy, 36(5), 545-566. doi:10.1016/S0005-7967(98)00034-5
Timepoint [15] 343441 0
1) At recruitment (Baseline 1; Pre-intervention)
2) 1 month after recruitment (Baseline 2; Pre-intervention)
3) 4-months from the intervention commencement date (Post-intervention)
4) 12-months from the intervention commencement date (Follow-up)

Eligibility
Key inclusion criteria
1) Parents-adolescent dyads - only one parent and one adolescent per family can participate in the trial.
2) Parents of adolescents aged 12- to 18-years
3) Upon entry to the trial, adolescents are receiving professional treatment for anxiety and depression (for example by general practitioners, school counsellors, clinical psychologists). No anxiety or depression threshold criteria will apply to the parent for participation in the intervention. However, adolescent levels of anxiety, depression or sleep problems (by the SMFQ, SCAS, PROMIS sleep questionnaires) and details of the treatment process and progress will be measured as a potential covariate.
4) Parent and adolescent are proficient in the English language
5) Parent and adolescent have telephone, internet and email access
6) Consent provided by parent for their own and their adolescent to participate; verbal assent provided by adolescent to participate (consent from the adolescent if they have turned 18 by follow-up assessments)
7) Parent and adolescents reside in Australia
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
NA

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
To address some limitations of a single-arm design, this trial employs a double-baseline whereby the participating parent-adolescent dyad completes pre-intervention measures twice, separated by a 1-month interval. In measuring changes to adolescent anxiety, depression and sleep outcomes between two time-points prior to parents receiving the TOPS intervention, the confounding effects of concurrent adolescent treatment during the parenting intervention can be accounted for through the analysis methods used (i.e. mixed models methods; refer to Statistical methods/analysis section below). Noted also is that, irrespective of the number of modules parents choose to engage with during the course of the intervention, post-intervention assessments will be measured 4-months after intervention commencement.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of N equal to 70 is required to meet a minimum effect size of Cohen’s d equal to 0.35, at alpha less than .05 and power equal to .80 accounting for an attrition rate of 15% using a repeated t-test measure. The sample size derived was based on the smallest expected effects size across all primary outcomes.

Standard descriptives and bivariate correlations would be generated for preliminary analysis and to provide baseline data. Sample characteristics will be evaluated by comparing against relevant population data that are available (e.g. Australian Bureau of Statistics).

Rates of participant recruitment, and attrition will be calculated using frequency statistics. Intervention adherence will be summarized through examining number of completed intervention sessions and drop-out rate. Descriptive statistics will be used to summarize mean ratings of intervention satisfaction and adherence.

Changes in parenting outcomes at pre-intervention to post-intervention and changes in anxiety, depression and sleep outcomes in adolescents from pre-intervention to 12-month follow-up will be examined using multilevel modelling via the Mplus software, which detects change over time and accounts for the nested data structure, retains all available data, and accommodates for missing data. All other secondary outcomes will also be similarly tested in accordance to their stipulated primary timepoints.

Prior to model testing, Pearson correlations and independent sample t-tests will be used to assess whether intervention outcomes varied by pre-intervention variables, to identify possible covariates to include in outcome analyses. Repeated measures t-test and effect size (Cohen’s d) will calculated to describe changes in each variable at the different time points.

Following this, the longitudinal mixed models method, either through latent growth curve modelling or latent change score modelling (Grimm, Zhang, Hamagami, & Mazzocco, 2013) will be employed to analyse changes to primary outcome at pre- and post-intervention, and secondary outcomes at pre-intervention and followup. This analysis will enable comparison between the magnitude of change to outcomes observed between the two baselines that may be attributed to factors external to the parenting intervention and the magnitude of change arising from the parenting intervention (inclusive of any ongoing adolescent intervention) administered after the double-baseline at post-treatment and then again at 12-month follow-up. For the intervention to be considered effective the magnitude of change to outcomes at post-treatment or follow-up must be significantly larger than the rate of change observed at baseline. Models will be fitted initially unadjusted, and followed up with adjustments of potential covariates.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2018
Actual
28/03/2018
Date of last participant enrolment
Anticipated
17/05/2019
Actual
21/05/2019
Date of last data collection
Anticipated
12/05/2020
Actual
Sample size
Target
70
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 298181 0
University
Name [1] 298181 0
Monash University
Country [1] 298181 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Psychological Sciences,
Monash University,
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Australia
Country
Australia
Secondary sponsor category [1] 297569 0
None
Name [1] 297569 0
Address [1] 297569 0
Country [1] 297569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299218 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 299218 0
Ethics committee country [1] 299218 0
Australia
Date submitted for ethics approval [1] 299218 0
25/10/2017
Approval date [1] 299218 0
18/12/2017
Ethics approval number [1] 299218 0
Project-11095

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2276 2276 0 0
/AnzctrAttachments/368031-Project 11095- Certificate of Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 55182 0
A/Prof Marie Yap
Address 55182 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 55182 0
Australia
Phone 55182 0
+61 3 9905 0723
Fax 55182 0
Email 55182 0
marie.yap@monash.edu
Contact person for public queries
Name 55183 0
Sarah Khor
Address 55183 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 55183 0
Australia
Phone 55183 0
+61 3 9905 1250
Fax 55183 0
Email 55183 0
med-tops.coach@monash.edu
Contact person for scientific queries
Name 55184 0
Marie Yap
Address 55184 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 55184 0
Australia
Phone 55184 0
+61 3 9905 0723
Fax 55184 0
Email 55184 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 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
SourceTitleYear of PublicationDOI
EmbaseShort-term outcomes of the Therapist-assisted Online Parenting Strategies intervention for parents of adolescents treated for anxiety and/or depression: A single-arm double-baseline trial.2022https://dx.doi.org/10.1177/00048674211025695
N.B. These documents automatically identified may not have been verified by the study sponsor.