Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001365752
Ethics application status
Approved
Date submitted
16/10/2022
Date registered
25/10/2022
Date last updated
25/10/2022
Date data sharing statement initially provided
25/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the acceptability of a self-guided online parenting program (‘PiP-Ed’) 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 self-guided, online parenting program (‘PiP-Ed’) to support parents of adolescents who refuse school in the context of anxiety and/or depression.
Secondary ID [1] 308194 0
None
Universal Trial Number (UTN)
U1111-1283-9499
Trial acronym
Linked study record
ACTRN12622000977774
UTN: U1111-1277-3180
The current trial is a parallel trial evaluating a self-guided version of the coach-supported PiP-Ed program being evaluated in trial ACTRN12622000977774. As the online program in these trials is the same, we consider this to be a sub-study.

Health condition
Health condition(s) or problem(s) studied:
Parental self-efficacy 327935 0
Adolescent school refusal 327936 0
Condition category
Condition code
Public Health 325003 325003 0 0
Health promotion/education
Mental Health 325004 325004 0 0
Anxiety
Mental Health 325005 325005 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 online Partners in Parenting (PiP) program (see previous trials: ACTRN12615000247572, ACTRN12615000328572, ACTRN12619001781134, ACTRN12621000854831). The original PiP program is designed to equip parents with evidence-based parenting strategies to reduce the risk or impact of anxiety or depression in their adolescent. The version of PiP evaluated in the current trial is a self-guided version of the coach-supported PiP-Ed program (see ACTRN12622000977774). PiP-Ed has been adapted 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.

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.

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 link to access a PDF copy of the Guidelines.

3) Parents are then recommended up to 12 of the interactive online modules.
All parents in the current trial will be recommended the following 6 modules regardless of PRADAS responses, as these are considered critical topics for parents of adolescents with school refusal (the “core” modules of the PiP-Ed program): 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, and 6) 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 Expert-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 receive 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.

Please see secondary outcome 2 for details of how program completion will be calculated. Module completion will be monitored using website analytics.

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.

Parenting Strategies Program (2013). How to prevent depression and clinical anxiety in your teenager: Strategies for parents. Melbourne: beyondblue.
Intervention code [1] 324647 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332814 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 intervention (efficacy is not a primary outcome of interest in this trial).

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] 332814 0
Post-intervention: 3-months (90 days) from baseline assessment completion date.
Secondary outcome [1] 414767 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] 414767 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 3-months (90 days) from baseline assessment completion date
Secondary outcome [2] 414768 0
Intervention feasibility (quantitative).
The feasibility of the program will be assessed by the number of modules completed.
We will consider the intervention feasible if 40% or more of the sample (for N= 200, 95% CI [33.2, 47.2]) complete 2 or more of the core modules.
See the section 'Description of intervention(s) / exposure' for explanation of the core program modules.
Module completion data will be captured via website analytics.
Timepoint [2] 414768 0
Post-intervention: 3-months (90 days) from baseline assessment completion date.
Secondary outcome [3] 414769 0
Validity of the intervention design (qualitative).
The validity of the intervention design will be explored with a subset of participants (10-15) 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 Theoretical Framework of Acceptability (TFA) questionnaire (Sekhon et al. 2022).

Reference:
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 [3] 414769 0
Post-intervention: 3-months (90 days) from baseline assessment completion date.
Secondary outcome [4] 414770 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] 414770 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 3-months (90 days) from baseline assessment completion date
Secondary outcome [5] 414771 0
Risk and protective factors for adolescent depression and anxiety disorders that parents can potentially modify (quantitative).
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] 414771 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 3-months (90 days) from baseline assessment completion date
Secondary outcome [6] 414772 0
Intervention acceptability (qualitative).
Acceptability of the intervention will be assessed qualitatively via semi-structured qualitative interviews with a subset of participants (10-15 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 [6] 414772 0
Post-intervention: 3-months (90 days) from baseline assessment completion date

Eligibility
Key inclusion criteria
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
None

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
Because this is an acceptability trial, no strict lower or upper limit on sample size has been set.
We aim to recruit 200 parents, which will enable us to assess intervention feasibility, as defined above (for N=200, feasibility cut-off of 40% or more of sample completing at least 2 modules, with 95 Confidence Interval [33.2, 47.2]).

For qualitative interviews, we will recruit 10-15 parents from the full sample. This 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 completed, percentage of the sample who adhered to program requirements) at 3-months post-intervention.

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-intervention scores on all other secondary outcome measures (PSES-SR, 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
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/10/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312449 0
University
Name [1] 312449 0
Monash University
Country [1] 312449 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] 314027 0
None
Name [1] 314027 0
Address [1] 314027 0
Country [1] 314027 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311795 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 311795 0
Ethics committee country [1] 311795 0
Australia
Date submitted for ethics approval [1] 311795 0
27/09/2022
Approval date [1] 311795 0
28/09/2022
Ethics approval number [1] 311795 0
32704

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

Contacts
Principal investigator
Name 122394 0
A/Prof Marie Yap
Address 122394 0
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Building 17, 18 Innovation Walk Clayton Campus, Clayton VIC 3800 Australia
Country 122394 0
Australia
Phone 122394 0
+61 3 9905 0723
Fax 122394 0
Email 122394 0
marie.yap@monash.edu
Contact person for public queries
Name 122395 0
Mairead Cardamone-Breen
Address 122395 0
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Building 17, 18 Innovation Walk Clayton Campus, Clayton VIC 3800 Australia
Country 122395 0
Australia
Phone 122395 0
+61 3 9905 1250
Fax 122395 0
Email 122395 0
mairead.cardamone-breen@monash.edu
Contact person for scientific queries
Name 122396 0
Mairead Cardamone-Breen
Address 122396 0
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Building 17, 18 Innovation Walk Clayton Campus, Clayton VIC 3800 Australia
Country 122396 0
Australia
Phone 122396 0
+61 3 9905 1250
Fax 122396 0
Email 122396 0
mairead.cardamone-breen@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
No additional documents have been identified.