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Trial registered on ANZCTR


Registration number
ACTRN12625000108415p
Ethics application status
Submitted, not yet approved
Date submitted
24/12/2024
Date registered
30/01/2025
Date last updated
30/01/2025
Date data sharing statement initially provided
30/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the acceptability of a therapist-assisted, online parenting program (‘PiP-TEx’) to support parents of adolescents who are experiencing anxious and/or depressive symptoms following a traumatic event.
Scientific title
An open-label, uncontrolled acceptability trial of a therapist-assisted, online parenting program (‘PiP-Trauma Exposure’) to support parents of adolescents who are experiencing anxious and/or depressive symptoms following a traumatic event.
Secondary ID [1] 313572 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent mental health 336091 0
Parental self-efficacy 336092 0
Carer burden 336093 0
Adolescent trauma 336094 0
Condition category
Condition code
Mental Health 332648 332648 0 0
Anxiety
Mental Health 332649 332649 0 0
Depression
Public Health 332650 332650 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, ‘Partners in Parenting-Trauma Exposure’ (PiP-TEx), 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-TEx has been adapted to empower parents to support their adolescent who have experienced a traumatic event.

The PiP-TEx intervention has two components:
1) a web-based program drawn from the Partners in Parenting intervention (refer to ACTRN12623000266662 and ACTRN12615000328572 and ACTRN12619001781134) which includes a parenting self-assessment with tailored feedback about the parent's current parenting practices and up to 12 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 12 self-directed online modules covering topics related to parenting an adolescent who experience anxious and/or depressive symptoms after a traumatic event: 1) understanding anxiety and depression, 2) parent-teen relationships, 3) breaking the anxiety cycle, 4) understanding trauma, 5) supporting teen trauma recovery, 6) minimising conflict, 7) establishing family rules, 8) encouraging good habits, 9) problem-solving, 10) parental involvement and autonomy granting, 11) encouraging supportive relationship, 12) relapse prevention.

Parents will attend up to 8, one-hour coaching sessions, over a 12-week period. Parents will be encouraged to complete coaching session weekly. The first coaching session includes an orientation component before educational materials. The coaching will be held with a PiP-TEx 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-TEx coaches are provisional psychologists completing a PhD (Clinical Psychology) at Monash University. All coaches will receive an intensive training program which will include online learning materials and live and/or recorded role-play exercises with feedback. Training will be completed at least one month prior to commencing the intervention and will be provided by a clinical psychologist within the research team. 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). Coaching sessions are manualised to ensure standardised delivery of the intervention.

Parents will receive the following as part of the PiP-TEx 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-TEx program). Parents are also emailed a link to access a PDF copy of the Guidelines.

3) Parents will receive at least 8 core modules but are recommended up to 12 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 experienced a traumatic event: 1) understanding anxiety and depression, 2) parent-teen relationships, 3) breaking the anxiety cycle, 4) understanding trauma, 5) supporting teen trauma recovery, 6) minimising conflict, 7) establishing family rules, 8) relapse prevention.
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 experience anxious and/or depressive symptoms following a traumatic event. Parents can further tailor their program by selecting additional modules or de-selecting optional modules recommended to them. Therefore in addition to the 8 core modules, parents can select up to 4 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 12 weeks to complete a maximum of 8 coaching sessions and will be encouraged to attend weekly. The eight topics which offer both coaching session and associated modules are: 1) understanding anxiety and depression, 2) parent-teen relationships, 3) breaking the anxiety cycle, 4) understanding trauma, 5) supporting teen trauma recovery, 6) minimising conflict, 7) establishing family rules, 8) relapse prevention.

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.

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

Note. Adolescents will not participate within this study included in coaching sessions or have access to the modules.

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] 330206 0
Behaviour
Comparator / control treatment
This is an initial, exploratory study, and thus there is no comparator or control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340233 0
Intervention acceptability (quantitative).
Timepoint [1] 340233 0
Post-Intervention: 3-months (90 days) from baseline assessment completion date (primary timepoint).
Secondary outcome [1] 443439 0
Parental self-efficacy about responding to trauma (quantitative).
Timepoint [1] 443439 0
Post-intervention: 3-months (90 days) from baseline assessment completion date.
Secondary outcome [2] 443441 0
Intervention feasibility (quantitative)
Timepoint [2] 443441 0
Post-intervention: 3 months (90 days) from parent baseline completion date.
Secondary outcome [3] 443446 0
Validity of the intervention design (qualitative).
Timepoint [3] 443446 0
Post-intervention: 3-months (90 days) from baseline assessment completion date.
Secondary outcome [4] 443447 0
Risk and protective factors for adolescent depression and anxiety disorders that parents can potentially modify (quantitative).
Timepoint [4] 443447 0
Post-intervention: 3-months (90 days) from baseline assessment completion date.
Secondary outcome [5] 443449 0
Intervention acceptability (qualitative).
Timepoint [5] 443449 0
Post-intervention: 3-months (90 days) from baseline assessment completion date
Secondary outcome [6] 444180 0
Intervention feasibility (quantitative)
Timepoint [6] 444180 0
Post-intervention: 3-months (90 days) from baseline assessment completion date.

Eligibility
Key inclusion criteria
Participants must be parents and/or guardians who:
(1) Have an adolescent aged 12-18 years who:
- Has experienced a traumatic event at least 1 month, and no more than 3 years ago.
- Has experienced the onset, or worsening, of anxious and/or depressive symptoms following this traumatic event.
(2) Live in Australia
(3) Can read, write, speak, and hear in English
(4) Have regular access to the Internet, a telephone, and email
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Parents of an adolescent who is currently in an unsafe environment related to their trauma, for example living with the perpetrator of their abuse.
2. Parents who are the perpetrator of their teen’s trauma.
3. Parents of an adolescent with a principal mental health condition of sufficient severity to require immediate clinical prioritisation (e.g. current alcohol/substance dependence, acute mental health crisis, acute crisis related to the trauma, recent suicide attempt or inpatient treatment).
4. Parents whose adolescent is engaged in treatment that involves parenting work or family therapy.

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
A sample size of 5-10 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 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 and feasibility 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 other outcome measures (Parental Self-Efficacy to Support Teens After a Potentially Traumatic Event, PSES, PRADAS, K-6, RCADS - Parent).

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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318037 0
University
Name [1] 318037 0
Monash University
Country [1] 318037 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320381 0
None
Name [1] 320381 0
Address [1] 320381 0
Country [1] 320381 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316692 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 316692 0
Ethics committee country [1] 316692 0
Australia
Date submitted for ethics approval [1] 316692 0
17/12/2024
Approval date [1] 316692 0
Ethics approval number [1] 316692 0

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

Contacts
Principal investigator
Name 138686 0
A/Prof Marie Yap
Address 138686 0
School of Psychological SciencesBuilding 17, 18 Innovation Walk, Monash University, Clayton, Victoria, 3800
Country 138686 0
Australia
Phone 138686 0
+61 3 9905 0723
Fax 138686 0
Email 138686 0
marie.yap@monash.edu
Contact person for public queries
Name 138687 0
Caitlyn King
Address 138687 0
School of Psychological Sciences Building 17 18 Innovation Walk Monash University Clayton Victoria 3800
Country 138687 0
Australia
Phone 138687 0
+61 3 9905 0723
Fax 138687 0
Email 138687 0
caitlyn.king@monash.edu
Contact person for scientific queries
Name 138688 0
Marie Yap
Address 138688 0
School of Psychological SciencesBuilding 17, 18 Innovation Walk, Monash University, Clayton, Victoria, 3800
Country 138688 0
Australia
Phone 138688 0
+61 3 9905 0723
Fax 138688 0
Email 138688 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.