Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000684628p
Ethics application status
Submitted, not yet approved
Date submitted
9/06/2023
Date registered
26/06/2023
Date last updated
26/06/2023
Date data sharing statement initially provided
26/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Family Life Skills Triple P for Carers of Young People with Challenging Mental Health Problems: A Feasibility Trial
Scientific title
Family Life Skills Triple P for Carers of Young People with Severe and Complex Mental Health Problems: A Feasibility Trial
Secondary ID [1] 309839 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent Mental Health 330268 0
Parenting adolescents with mental health problems 330269 0
Parenting adolescents with severe and complex mental health 330402 0
Condition category
Condition code
Mental Health 327136 327136 0 0
Other mental health disorders
Mental Health 327176 327176 0 0
Depression
Mental Health 327177 327177 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study seeks to determine the effectiveness of the Family Life Skills Triple P Program and Group Teen Triple P, when compared to the delivery of Group Teen Triple P alone. All participants in the study will receive 4 x 90 min sessions of the Group Teen Triple P programme, which has an established evidence base for adolescents (see notes in comparator/control treatment). All participants will also receive 3 x 30 min individual phone calls with a clinician at the end of the group sessions to support application of the skills to their individual family context circumstances. This will be provided for both the active control (GTTP), and the intervention group (FLSTP + GTTP). We anticipate that the groups will be between 8-10 parents in a group, with a max. of 10 people in each group. Every group will have two practitioner facilitators per group.

The intervention:
Family Life Skills Triple P (FLSTP) is an enhanced version of Group Teen Triple P (GTTP). For this project, FLSTP will be an additional 6 x 90-minute session program that encourages parents to apply the self-regulatory skills they learn during the 4 sessions of Group Teen Triple P parenting program (e.g., goal-setting, planning ahead, self-monitoring, self-reflection) to broader life skills they need to function as healthy, well-adjusted and contributing members of the community. The FLSTP group sessions will focus on a range of life domains: coping with emotions, taking care of relationships, taking care of oneself, dealing with the past, developing healthy habits, and looking to the future.

Participants in the intervention arm will receive parenting skills training through four group sessions of GTTP followed by six FLSTP group sessions all facilitated via weekly videoconference by accredited Triple P practitioners employed by Children's Health Queensland Health & Hospital Service (CHQ HHS). The FLSTP group sessions will be conducted with parents/carers only; there will be no direct contact with young people during this study. The study will not involve participants incurring any costs – all materials will be provided to them as part of the research. All participants will also receive 3 x 30 min individual phone calls with a clinician at the end of the group sessions to support application of the skills to their individual family context circumstances.

The content of these 6 sessions is summarised below:
Family Life Skills Triple P
Module 2
5. Coping with emotions
• Recognising unpleasant emotions
• How emotions affect parenting
• Dealing with unpleasant emotions
• How emotions work
• Coping statements
• Personal coping plans

Module 3
6. Taking care of relationships
• Importance of relationships to wellbeing and family life
• Effective communication skills (positive and negative communication habits)
• Casual conversations
• Problem solving
• Improving relationship happiness

Module 4
7. Taking care of yourself
• Why focus on taking care of yourself?
• What is compassion and why is it important?
• How the mind works
• Mindfulness
• Building your compassionate self
• Future goals


Module 5
8. Dealing with the past
• What we bring to parenting
• What are negative life events and how do they affect us?
• Dealing with difficult memories
• Breaking the cycle
• Personal coping plans

Module 6
9. Developing Healthy Habits
• What are habits?
• Addictive behaviours
• Recognising unhelpful habits
• Evaluating unhelpful habits
• Motivation to change
• Understanding unhelpful habits
• Changing a habit, developing a personal habit breaking plan
• When to seek help

Module 7
10. Looking to the future
• Phasing out the program
• Progress review (reviewing goals attained)
• Keeping up the good changes
• 10-point action plan for a healthy lifestyle
• Making lifestyle changes
• Future goals
• Wrap up and final assessment

Parents receive a workbook delivered to them via postal service which provides content, exercises for completion and their homework tasks. Group sessions are delivered by a multi-disciplinary team which may include nurses, psychologists, social workers, speech pathologists, psychiatrists and occupational therapists. All practitioners are trained to criterion. These practitioners will also conduct the individual consultations.

Participants who miss sessions may receive instructions on workbook exercises to complete, and a follow-up phone call from their practitioners to ensure that the session has been sufficiently completed.

To maintain fidelity, and reduce drift over time, practitioners will participate in a cumulative 8-day training, use a manual, attend weekly supervision sessions and complete post-session adherence checklists. A random selection of sessions will be recorded and reviewed for program adherence by an independent practitioner outside of the service delivery team.
Intervention code [1] 326268 0
Behaviour
Comparator / control treatment
The study makes use of an active control, and compares the intervention (i.e. the Family Life Skills Program and Group teen Triple P described previously) to the delivery of Group Teen Triple P alone. Group Teen Triple P is an evidence-based parenting intervention that already has sound support for parents of adolescents. We anticipate that the groups will be between 8-10 parents in a group, with a max. of 10 people in each group. Every group will have two practitioner facilitators per group.

The Control:
Participants in the control arm of the study will receive 4 x 90 min sessions of the Group Teen Triple P programme. All participants will also receive 3 x 30 min individual phone calls with a clinician at the end of the group sessions to support application of the skills to their individual family context circumstances. These groups are facilitated by weekly videoconference by accredited Triple P practitioners who are employed by CHQ HHS. The GTTP sessions will provide participants with information, activities and resources on the principles of positive parenting, encouraging appropriate behaviour, teaching new skills, managing problem behaviour, planning ahead for risky situations, and raising confident, capable teenagers.

The content of these 6 sessions is summarised below:

Module 1
1 Positive Parenting
• Ensuring a safe, engaging environment
• Creating a positive learning environment
• Using assertive discipline
• Having realistic expectations
• Taking care of yourself as a parent
• Factors influencing teenagers’ behaviour
• Genetic make-up
• The family environment
• Influences outside the home
• Goals for change and Keeping track

2 Encouraging Appropriate Behaviour
• Developing positive relationships with teenagers
• Increasing desirable behaviour
• Teaching new skills and behaviours
• Behaviour contract guidelines
• Family meetings

3 Managing Problem Behaviour
• Establishing clear family rules
• Using directed discussion to deal with rule-breaking
• Making clear, calm requests
• Backing up your requests with logical consequences
• Acknowledging teenagers' emotions
• Using a behaviour contract to manage problem behaviour

4 Dealing with Risky Behaviour
• Imposed Prevention
• Routine for dealing with emotional behaviour
• Principle of rules for teenagers
• Group A and B behaviour
• Back-up Consequences
• Family Survival Tips
• Monitoring teen activity
• Preparing for telephone sessions

Parents receive a workbook delivered to them via postal service which provides content, exercises for completion and their homework tasks. Group sessions are delivered by a multi-disciplinary team which may include nurses, psychologists, social workers, speech pathologists, psychiatrists and occupational therapists. All practitioners are trained to criterion. These practitioners will also conduct the individual consultations.

Participants who miss sessions may receive instructions on workbook exercises to complete, and a follow-up phone call from their practitioners to ensure that the session has been sufficiently completed.

To maintain fidelity, and reduce drift over time, practitioners will participate in a cumulative 8-day training, use a manual, attend weekly supervision sessions and complete post-session adherence checklists. A random selection of sessions will be recorded and reviewed for program adherence by an independent practitioner outside of the service delivery team.

Control group
Active

Outcomes
Primary outcome [1] 335012 0
Parent Measure
Construct: General Self-Regulation
Measured by: Scores on the Brief Self Control Survey (BSCS)
Timepoint [1] 335012 0
At two timepoints, these will be compared to significant % changes relative to their baseline scores:
-within 7 days of the group sessions ending
-at 6 months (26 weeks) follow-up after the group sessions have ended
Primary outcome [2] 335123 0
Parent measure
Construct: Emotional Regulation
Measured by scores on the Emotional Regulation Questionnaire (ERQ)
Timepoint [2] 335123 0
At two timepoints, these will be compared to significant % changes relative to their baseline scores:
-within 7 days of the group sessions ending
-at 6 months (26 weeks) follow-up after the group sessions have ended
Primary outcome [3] 335124 0
Parent Measure
Construct: Parenting Self-Regulation
Measured by scores on the Me as a Parent Scale (MaaPS)
Timepoint [3] 335124 0
At two timepoints, these will be compared to significant % changes relative to their baseline scores:
-within 7 days of the group sessions ending
-at 6 months (26 weeks) follow-up after the group sessions have ended
Secondary outcome [1] 422708 0
Parent Measure
Construct: Parenting Self-Efficacy
Measured by Scores on the Self-Efficacy for Parenting Adolescents Scale (SEPAS)
NOTE: This is a PRIMARY OUTCOME measure
Timepoint [1] 422708 0
At two time points, these will be compared to significant % changes relative to their baseline scores:
-within 7 days of the group sessions ending
-at 6-months (26 weeks) follow-up after the group sessions have ended
Secondary outcome [2] 422709 0
Parent Measure
Construct: Family Adjustment
Measured by scores on the Parenting & family Adjustment Scale (PAFAS)
Note: This is a PRIMARY OUTCOME measure
Timepoint [2] 422709 0
At two time points, these will be compared to significant % changes relative to their baseline scores:
-within 7 days of the group sessions ending
-at 6-months (26 weeks) follow-up after the group sessions have ended
Secondary outcome [3] 423116 0
Parent Measure
Construct: Family Functioning & Change
Measured by scores on the SCORE-15
Note: This is a PRIMARY OUTCOME measure
Timepoint [3] 423116 0
At two time points, these will be compared to significant % changes relative to their baseline scores:
-within 7 days of the group sessions ending
-at 6-months (26 weeks) follow-up after the group sessions have ended
Secondary outcome [4] 423135 0
Parent Measure
Construct: Parent emotional distress
Measured by the Depression Anxiety Stress Scale-21 (DASS21)
Note: This is a PRIMARY OUTCOME measure
Timepoint [4] 423135 0
At two time points, these will be compared to significant % changes relative to their baseline scores:
-within 7 days of the group sessions ending
-at 6-months (26 weeks) follow-up after the group sessions have ended
Secondary outcome [5] 423136 0
Parent Measure
Construct: Parent health & wellbeing
Measured by the WHO (Five) Wellbeing Index (1998 version)
Note: This is a PRIMARY OUTCOME measure
Timepoint [5] 423136 0
At two time points, these will be compared to significant % changes relative to their baselines scores:
-within 7 days of the group sessions ending
-at 6-months (26 weeks) follow up after the group sessions have ended
Secondary outcome [6] 423137 0
Adolescent measure
Construct: Adolescent behaviour
Measured by parent report on the Strengths & Difficulties Questionnaire (SDQ) Parent (11-17 years).
Timepoint [6] 423137 0
At two time points, these will be compared to significant % changes relative to their base-line scores
-within 7 days of the group sessions ending
-at 6 months (26 weeks) follow-up after the group sessions have ended
Secondary outcome [7] 423138 0
Adolescent measure
Construct: Mental health symptomatology
Measured by The Health of the Nation Outcomes Scales for Children and Adolescent (HoNOSCA)
Timepoint [7] 423138 0
At two time points, these will be compared to significant % changes relative to their base-line scores
-within 7 days of the group sessions ending
-at 6 months (26 weeks) follow-up after the group sessions have ended
Secondary outcome [8] 423139 0
Adolescent Measure
Construct: Adolescent global functioning
Measured by the Children's Global Assessment Scale (CGAS)
Timepoint [8] 423139 0
At two time points, these will be compared to significant % changes relative to their base-line scores
-within 7 days of the group sessions ending
-at 6 months (26 weeks) follow-up after the group sessions have ended
Secondary outcome [9] 423140 0
Parent measure
Construct: Parents perceptions of usability, acceptability and appropriateness of the material to their needs
This is measured by their responses on a Client Satisfaction Questionnaire
Timepoint [9] 423140 0
Within 7 days of completing the group sessions
Secondary outcome [10] 423141 0
Practitioner Measure
Construct: Practitioner perceptions of usability, acceptability and appropriateness of the material to both families and practitioners
Practitioners are invited to participate in an individual semi-structured interview (30 minutes) to provide their feedback on the groups useability, acceptability and appropriateness to parents of this cohort of adolescents.
Timepoint [10] 423141 0
Within 4 weeks of competing running a group.
Secondary outcome [11] 423165 0
A small minority of 17-year-old adolescents whose parents participate in the program will turn 18 during their parents' progression. Adolescent measures routinely administered will no longer be valid. As part of their typical care, they are measured on adult measures instead. These will be used instead of the adolescent measures as post-intervention and follow-up measures:
Construct: Mental health & social functioning of adults
Measured by the Health of the Nation Outcome Scale (HoNOS)
Timepoint [11] 423165 0
Potentially at two time points, these will be compared to significant % changes relative to their base-line scores
-within 7 days of the group sessions ending
-at 6 months (26 weeks) follow-up after the group sessions have ended
This will be assessed on a case-by-case basis given we cannot control when they will turn 18 years.
Secondary outcome [12] 423166 0
A small minority of 17-year-old adolescents whose parents participate in the program will turn 18 during their parents' progression. Adolescent measures routinely administered will no longer be valid. As part of their typical care, they are measured on adult measures instead. These will be used instead of the adolescent measures as post-intervention and follow-up measures:
Construct: Adult general functioning
Measured by the Life Skills Profile (LSP-16)
Timepoint [12] 423166 0
Potentially at two time points, these will be compared to significant % changes relative to their base-line scores
-within 7 days of the group sessions ending
-at 6 months (26 weeks) follow-up after the group sessions have ended
This will be assessed on a case-by-case basis given we cannot control when they will turn 18 years.
Secondary outcome [13] 423167 0
A small minority of 17-year-old adolescents whose parents participate in the program will turn 18 during their parents' progression. Adolescent measures routinely administered will no longer be valid. As part of their typical care, they are measured on adult measures instead. These will be used instead of the adolescent measures as post-intervention and follow-up measures:
Construct: Mental health symptomatology
Measured by Mental Health Inventory (MHI)
Timepoint [13] 423167 0
Potentially at two time points, these will be compared to significant % changes relative to their base-line scores
-within 7 days of the group sessions ending
-at 6 months (26 weeks) follow-up after the group sessions have ended
This will be assessed on a case-by-case basis given we cannot control when they will turn 18 years.

Eligibility
Key inclusion criteria
Parents/carers of a young person aged 12-17years with severe and complex mental health difficulties, who are either on the waitlist for Jacaranda Place Adolescent Unit or Day Program or referred from one of the following state-wide services:
* community CYMHS clinics
* E-CYMHS
* CHQ HHS Emergency Departments (ED)
where presenting for serious and complex mental health difficulties.

Practitioner participants are mental health clinicians employed by Jacaranda Place (Adolescent Extended Treatment Centre) (a campus of CHQ HHS), and typically work with adolescents and their families in their roles on the Adolescent Unit or the Day Programme.
They are included in the study if they:
-have completed the Triple P training to run a group
-ran at least one group with parents/carers
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents of adolescents with severe and complex mental health challenges will be ineligible for participation if:

(i) their adolescent has an intellectual disability;
(ii) parents are currently participating in another parenting intervention;
(iii) parents have difficulties reading and completing forms in English.

For participant practitioners, there are no exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes, that were administered by an independent worker outside of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (randomised within each block of 10), with no stratification.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features


Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a small to medium effect size on the Me as a Parent (MaaP) scale, with 80% power, CI of 95%, a total sample size of 58 (29 per arm) is needed. Allowing for 20% attrition, the recruitment aim is 73 families in total.

Variables will be examined for out-of-range values, inter- and intra-measure consistency, and unusual distributions or data points. Strategies will be implemented to minimise missing data. Data will be analysed using SPSS statistical software package.

All analyses will be done on an intent-to-treat basis, including all participants who complete baseline assessment, regardless of whether they commence or complete the intervention. A series of ANCOVAs may be used to determine if post-intervention (T2 and T3) means, adjusted for pre-intervention scores, differ between the groups. Cohen’s d effect sizes will be used to indicate the magnitude of the difference between means across time. The proportion of parents/carers and young people who move from the clinical range at baseline (on relevant measures) to non-clinical at post may also be calculated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/09/2023
Actual
Date of last participant enrolment
Anticipated
2/09/2024
Actual
Date of last data collection
Anticipated
10/03/2025
Actual
Sample size
Target
73
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24892 0
Jacaranda Place - Chermside
Recruitment postcode(s) [1] 40524 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 314022 0
Hospital
Name [1] 314022 0
Children's Health Queensland, Health and Hospital Service
Country [1] 314022 0
Australia
Primary sponsor type
Hospital
Name
Children's Health Queensland, Health and Hospital Service
Address
Queensland Children’s Hospital
501 Stanley Street
South Brisbane
QLD
4101
Country
Australia
Secondary sponsor category [1] 315912 0
University
Name [1] 315912 0
The University of Queensland
Address [1] 315912 0
St Lucia
Brisbane
Queensland
4072
Country [1] 315912 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313158 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 313158 0
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital Precint
62 Grahan Street
South Brisbane
QLD
4101
Ethics committee country [1] 313158 0
Australia
Date submitted for ethics approval [1] 313158 0
05/06/2023
Approval date [1] 313158 0
Ethics approval number [1] 313158 0

Summary
Brief summary
The broad aim of this effectiveness study is to conduct a pragmatic randomized controlled two-arm trial (RCT) to determine whether Family Life Skills Triple P plus Group Teen Triple P compared to Group Teen Triple P alone optimizes the parenting and self-regulatory skills, self-efficacy and well-being of parents and carers of young people (12 to 17 years) with severe and complex mental health problems. Recruitment will be statewide, and participants may include the parents/carers of young people (12 to 17 years) on the waitlist for Jacaranda Place Adolescent Unit and Day Program and those referred from referring community CYMHS clinics, E-CYMHS, and CHQ HHS Emergency Departments (ED) (where presenting for serious and complex mental health difficulties).

Data will be collected at baseline, post-intervention, and 6 months post intervention. Data will include parental self-report measures of family functioning, parenting, self- and emotional regulation, parental self-efficacy, parental assessment of adolescent wellbeing, as well as routine outcome measure (ROM) data recorded in the young persons’ electronic medical record. This is a pragmatic study to assess feasibility and effectiveness of the program in ‘real life’ conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127198 0
Dr Arun Pillai
Address 127198 0
Jacaranda Place
78 Farnell Street
Chermside
QLD
4032
Country 127198 0
Australia
Phone 127198 0
+61 721056000
Fax 127198 0
Email 127198 0
arun.pillai-sasidharan@health.qld.gov.au
Contact person for public queries
Name 127199 0
Dr Robyn Milligan
Address 127199 0
Jacaranda Place
78 Farnell Street
Chermside
QLD
4032
Country 127199 0
Australia
Phone 127199 0
+61 721056000
Fax 127199 0
Email 127199 0
robyn.milligan@health.qld.gov.au
Contact person for scientific queries
Name 127200 0
Dr Arun Pillai
Address 127200 0
Jacaranda Place
78 Farnell Street
Chermside
QLD
4032
Country 127200 0
Australia
Phone 127200 0
+61 721056000
Fax 127200 0
Email 127200 0
arun.pillai-sasidharan@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19390Study protocol  robyn.milligan@health.qld.gov.au Protocol - Family Life Skills Triple P for Carers ... [More Details] 386035-(Uploaded-19-06-2023-13-16-57)-Study-related document.docx



Results publications and other study-related documents

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