Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000977774
Ethics application status
Approved
Date submitted
23/06/2022
Date registered
11/07/2022
Date last updated
4/08/2023
Date data sharing statement initially provided
11/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the acceptability of a therapist-assisted, online parenting program (‘PiP-Education’) to support parents of adolescents who refuse school in the context of anxiety and/or depression.
Scientific title
An open-label, uncontrolled acceptability trial of a therapist-assisted, online parenting program (‘PiP-Education’) to support parents of adolescents who refuse school in the context of anxiety and/or depression.
Secondary ID [1] 307393 0
NIL
Universal Trial Number (UTN)
U1111-1277-3180
Trial acronym
Linked study record


Health condition
Health condition(s) or problem(s) studied:
Parental self-efficacy 326720 0
Carer burden 326722 0
Adolescent school refusal 326723 0
Condition category
Condition code
Public Health 323956 323956 0 0
Health promotion/education
Mental Health 323957 323957 0 0
Anxiety
Mental Health 323958 323958 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, ‘Partners in Parenting-Education’ (PiP-Ed), is a newly adapted version of the therapist-assisted online parenting strategies program (formerly known as 'TOPS' - refer to ACTRN12618000290291). The original TOPS 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-Ed has been optimised to support parents of adolescents who refuse school in the context of depression or anxiety disorders. School refusal is defined as persistent difficulty attending school due to significant emotional distress associated with attendance.

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

The web-based program includes 13, self-directed online modules covering topics related to parenting an adolescent who is refusing school due to anxiety and/or depression: 1) understanding anxiety and depression, 2) parent-teen relationships, 3) breaking the anxiety cycle, 4) understanding school refusal, 5) working together to respond to school refusal, 6) minimising conflict in the home, 7) establishing family rules, 8) parental involvement and autonomy granting, 9) encouraging supportive relationships, 10) encouraging good health habits, 11) problem-solving, 12) parenting through the pandemic, and 13) relapse prevention.

The coaching component involves parents attending a maximum of 8 PiP-Ed coaching sessions with a PiP-Ed coach via online videoconference. PiP-Ed coaches are all registered psychologists or provisional psychologists completing a PhD (Clinical Psychology) at Monash University. Each session takes 50-minutes. Parents will be encouraged to complete PiP-Ed coaching sessions weekly. PiP-Ed coaching sessions are manualised to ensure standardised delivery of the intervention.

Parents will receive the following as part of the PiP-Ed 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 (on their 'personal dashboard' as part of the PiP-Ed program). Parents are also emailed a PDF copy of the Guidelines.

3) Parents are recommended up to 12 interactive online modules.
All parents in the current trial will be recommended the following modules regardless of PRADAS responses, as these are considered critical topics for parents of adolescents with school refusal: 1) understanding anxiety and depression, 2) parent-teen relationships, 3) breaking the anxiety cycle, 4) understanding school refusal, 5) working together to respond to school refusal, 13) relapse prevention.
The remaining modules will be recommended based on identified areas for improvement (PRADAS scores), with the exception of the module 'Parenting through the pandemic' which will be optional for all parents.
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, and new school refusal-specific parenting recommendations developed in a Delphi Consensus Study. Parents can further tailor their program by selecting additional modules or de-selecting optional modules recommended to them. Parents can select between 1 and 13 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.

In parallel, parents will attend a maximum of 8 one-on-one PiP-Ed coaching sessions with a PiP coach via online videoconference. Parents will have a maximum of 3 months to complete their 8 PiP-Ed 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 goal between PiP-Ed coaching sessions. Post-session, parents will have access to an online summary of the session prepared by the coach, including key highlights from the session (e.g., important reflections, learnings, new skills, completed goals), accessible via a unique URL sent via email. Intervention adherence will be monitored through website analytics (module completion) and attendance records (coaching sessions).

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.

Lovibond, S.H. & Lovibond, P.F. (1995). Manual for the Depression Anxiety Stress Scales.

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.

Ebesutani, C., Korathu-Larson, P., Nakamura, B., Higa-McMillan, C., and 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
Intervention code [1] 323828 0
Behaviour
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331751 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).

NOTE: Measures of acceptability and feasibility will be used as as indicators of the safety of the new PiP-Ed intervention (efficacy is not a primary outcome of interest due to small sample size).
Timepoint [1] 331751 0
Post-intervention: 3-months (90 days) from baseline assessment completion date.
Secondary outcome [1] 411019 0
Parental self-efficacy about responding to school refusal (quantitative)

Change in parental self-efficacy to respond to school refusal will be measured using the total score on the Parental Self-efficacy Scale - School Refusal (PSES-SR). This scale was developed as part of the intervention development, and will be validated in a separate study concurrent to this trial; it is thus unpublished at the time of trial registration. The PSES-SR consists of 18 items which assess a parent's current level of confidence in responding to their teen's school refusal, measured on a four-point Likert scale (0 = 'not at all confident', 1 = 'a little confident', 2 = 'somewhat confident', 3 = 'very confident'). Higher scores indicate higher levels of parental self-efficacy.
Timepoint [1] 411019 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 3-months (90 days) from baseline assessment completion date (primary timepoint)
Secondary outcome [2] 411020 0
Intervention feasibility (quantitative)

The feasibility of the program will be assessed by:

1. Program completion rates: Percentage of selected online modules and coaching sessions completed by parents. Only the 8 topics which include both online modules and corresponding TOPS-Ed 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 OR coaching sessions] completed by parent, as determined by website analytics (modules) or audit of session attendance records (coaching sessions)
Intended usage = total number of [modules OR coaching sessions] selected by parent, as determined by website analytics

A completion rate of 75% or higher will be considered feasible.

2. Adherence to program requirements: The percentage of participants who complete the 6 required online modules and corresponding PiP-Ed coaching sessions. Percentages will be calculated separately for online modules and coaching sessions, as: 100% x [(number of participants whose observed usage equals their intended usage) / (number of participants who received the intervention)].

Observed usage = total number of [modules OR coaching sessions] completed by parent, as determined by website analytics (modules) or audit of session attendance records (coaching sessions)
Intended usage = total number of [modules OR coaching sessions] selected by parent. as determined by website analytics

Successful adherence will be defined as participant completion of 5 out of 6 online modules, and 5 out of 6 corresponding PiP-Ed coaching sessions.

NOTE: Measures of acceptability and feasibility will be used as as indicators of the safety of the new PiP-Ed intervention (efficacy is not a primary outcome of interest due to small sample size).
Timepoint [2] 411020 0
Post-intervention: 3-months (90 days) from baseline assessment completion date
Secondary outcome [3] 411021 0
Validity of the intervention design (qualitative) The validity of the intervention design will be explored in semi-structured qualitative interviews with parents. Interview questions will be designed to assess how program design features (such as program content, software, and features) influenced their self-efficacy to respond to school refusal (as measured by the PSES-SR) and experience of program acceptability (as measured by the CSQ-8 and the TFA acceptability questionnaire). Parents' suggestions about how the validity of the intervention design could be enhanced will also be explored.
Timepoint [3] 411021 0
Post-intervention: 3-months (90 days) from baseline assessment completion date
Secondary outcome [4] 411022 0
Adolescent school attendance rates (quantitative)

Change in adolescent school attendance rates as measured by parent self-report. Parents will respond to a single item 'How many days of school has your child refused to attend over the most recent 10 school days?'.
Timepoint [4] 411022 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 3-months (90 days) from baseline assessment completion date (primary timepoint)
Secondary outcome [5] 411023 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] 411023 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 3-months (90 days) from baseline assessment completion date (primary timepoint)
Secondary outcome [6] 411024 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 [6] 411024 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 3-months (90 days) from baseline assessment completion date (primary timepoint)
Secondary outcome [7] 411025 0
Intervention acceptability (qualitative).

Acceptability of the intervention will be assessed qualitatively via semi-structured qualitative interview (parents). The interview schedule will be based on items included in the Theoretical Framework of Acceptability (TFA) questionnaire (Sekhon et al. 2022). The generic version of the questionnaire items are 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.

References:
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
Timepoint [7] 411025 0
Post-intervention: 3-months (90 days) from baseline assessment completion date

Eligibility
Key inclusion criteria
Group 1: Parents and/or guardians of adolescents aged 12-18 years who:
- are refusing school due to anxiety and/or depression
- live in Australia
- are proficient in English
- have regular internet access
Minimum age
18 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 who experienced first onset of school refusal prior to the current school year (2022).
2. Parents of an adolescent who experiences a physical illness that precludes their school
attendance, or are refusing school for any reason other than due to anxiety/depression related to attendance.
3. Parents of an adolescent who has a principal mental health condition that is of sufficient severity to require immediate clinical prioritisation (e.g. suicidality, current alcohol/substance dependence, acute mental health crisis)
4. Parents of an adolescent who has Autism Spectrum Disorder (ASD) or an intellectual disability.

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
Statistical methods / analysis
Group 1: Parents
A sample size of 10-15 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).

Analysis of quantitative program acceptability and feasibility outcomes will be largely descriptive. Program acceptability, as measured quantitatively via the Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979), will be analysed individually for each participant. Scores of individual items in the CSQ-8 will be summed to yield a global rating of program satisfaction out of 32 for each participant. Quantitative program feasibility outcomes will be calculated as percentages (e.g., percentages of required online modules and TOPS-Ed coaching sessions completed, percentage of the sample who adhered to program requirements) at 3-months post intervention commencement.

Qualitative data collected via semi-structured interviews pertaining to program acceptability, feasibility, and validity will be analysed with thematic analysis, adhering to the 6 phases outlined by Braun & Clarke (2006) with themes identified inductively.

To assess preliminary indications of intervention response, paired samples t-tests will be conducted between pre- and post-treatment scores on all other secondary outcome measures (PSES-SR, BAS, PRADAS, school attendance).

References:
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

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.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2022
Actual
19/08/2022
Date of last participant enrolment
Anticipated
Actual
21/09/2022
Date of last data collection
Anticipated
Actual
17/02/2023
Sample size
Target
10
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311669 0
University
Name [1] 311669 0
Monash University
Country [1] 311669 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] 313123 0
None
Name [1] 313123 0
Address [1] 313123 0
Country [1] 313123 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311125 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 311125 0
Ethics committee country [1] 311125 0
Australia
Date submitted for ethics approval [1] 311125 0
08/06/2022
Approval date [1] 311125 0
27/07/2022
Ethics approval number [1] 311125 0
32704

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

Contacts
Principal investigator
Name 120026 0
A/Prof Marie Yap
Address 120026 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 120026 0
Australia
Phone 120026 0
+61 3 9905 0723
Fax 120026 0
Email 120026 0
[email protected]
Contact person for public queries
Name 120027 0
Anna Smout
Address 120027 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 120027 0
Australia
Phone 120027 0
+61 3 99051250
Fax 120027 0
Email 120027 0
[email protected]
Contact person for scientific queries
Name 120028 0
Marie Yap
Address 120028 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 120028 0
Australia
Phone 120028 0
+61 3 9905 0723
Fax 120028 0
Email 120028 0
[email protected]

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.