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Trial registered on ANZCTR


Registration number
ACTRN12618000981224
Ethics application status
Approved
Date submitted
31/05/2018
Date registered
12/06/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving outcomes in mental health for children and families: A study of Enhanced Stepping Stones Triple P
Scientific title
Improving outcomes in mental health: A randomised controlled trial of Enhanced Stepping Stones Triple P
Secondary ID [1] 294942 0
None
Universal Trial Number (UTN)
U1111-1214-3891
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 307916 0
Anxiety 307917 0
Attention-Deficit/Hyperactivity Disorder 307918 0
autism spectrum disorder 308063 0
Behavioral disorders 308064 0
Condition category
Condition code
Mental Health 307033 307033 0 0
Anxiety
Mental Health 307034 307034 0 0
Depression
Mental Health 307035 307035 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enhanced Group Stepping Stones Triple P

First, participants receive Group Stepping Stones Triple P (Level 4) which comprises 6 x 2.5-hour group sessions, held weekly at Queensland Children's Hospital or other suitable location. The sessions are designed for parents of children with special needs and guide them in using strategies to promote a positive relationship with their child, encourage desirable behavior, teach new skills and behaviors, and manage challenging and disruptive behavior. Sessions involve didactic teaching, viewing DVD segments, some role play, and completion of exercises in the provided participant workbook. Participants also receive 3 x 30-minute phone consultations, over 3 weeks. The phone consultations are designed to help parents put the learned content into practice at home. They involve the facilitator guiding parents to self-assess their homework task completion and set their own goals for the coming week.

Second, participants receive an additional 3 x 90-minute group sessions, over 3 weeks, which focus on using cognitive behavioural coping skills. These additional sessions are designed to address parental mood disturbance and focus on stress management and cognitive coping skills for managing depression, anxiety, stress and anger. Sessions involve didactic teaching, some role play, and completion of exercises in the provided participant workbook.

Participants receive 2 information workbooks, "Stepping Stones Triple P Group Workbook" and "Every Parent's Supplementary Workbook. Module 2: Coping Skills", both of which provide content, exercises for completion and homework tasks. The group sessions include viewing segments from the DVD "Stepping Stones Triple P: A survival guide for families with a child who has a disability".
Group sessions are conducted face-to-face by nurses, psychologists and graduate psychology interns who have been trained to criterion. The facilitators will also conduct the home-phone consultations.
Participants who miss sessions may receive instructions on workbook exercises to complete, and a follow-up phone call from their facilitator to ensure the session has been sufficiently completed.
Intervention code [1] 301320 0
Behaviour
Comparator / control treatment
Group Stepping Stones Triple P

Participants receive Group Stepping Stones Triple P (Level 4), only, which comprises 6 x 2.5 -hour group sessions, held weekly at Queensland Children's Hospital or other suitable location. The sessions are designed for parents of children with special needs and guide them in using strategies to promote a positive relationship with their child, encourage desirable behavior, teach new skills and behaviors, and manage challenging and disruptive behavior. Participants also receive 3 x 30-minute phone consultations, over 3 weeks. The phone consultations are designed to help parents put the learned content into practice.

Participants receive 1 information workbook, "Stepping Stones Triple P Group Workbook" which provides content, exercises for completion and homework tasks. The group sessions include viewing segments from the DVD "Stepping Stones Triple P: A survival guide for families with a child who has a disability".
Group sessions are conducted face-to-face by nurses, psychologists and graduate psychology interns who have been trained to criterion. The facilitators will also conduct the home-phone consultations.
Participants who miss sessions may receive instructions on workbook exercises to complete, and a follow-up phone call from their facilitator to ensure the session has been sufficiently completed.
To maintain fidelity and reduce drift over time, facilitators will participate in a standardised 3 to 4-day training, use a manual, attend supervision sessions and complete post-session adherence checklists. A random selection of sessions will be video-taped and reviewed for program adherence by a trained Triple P provider not associated with the study.
Control group
Active

Outcomes
Primary outcome [1] 306042 0
Change to parent depressive problems as assessed by the Adult Self-Report (ASR).
Timepoint [1] 306042 0
Baseline and 6 (primary timepoint), 12 and 24 months post baseline
Primary outcome [2] 306043 0
Change to parent anxiety problems as assessed by the Adult Self-Report (ASR).
Timepoint [2] 306043 0
Baseline and 6 (primary time-point), 12 and 24 months post baseline
Primary outcome [3] 306136 0
Change to parent avoidant personality problems as assessed by the ASR
Timepoint [3] 306136 0
Baseline and 6 (primary time-point), 12 and 24 months post baseline
Secondary outcome [1] 347401 0
Change to parenting practices and parental adjustment as assessed using the Parenting and Family Adjustment Scales (PAFAS)
Timepoint [1] 347401 0
Pre-intervention commencement and 7 days post-intervention completion
Secondary outcome [2] 347402 0
Change to level of conflict between partners over child-rearing as assessed using the Parent Problem Checklist.
Timepoint [2] 347402 0
Pre-intervention commencement and 7 days post-intervention completion
Secondary outcome [3] 347403 0
Change to relationship satisfaction as assessed by item 6 of the Relationship Quality Index (RQI)
Timepoint [3] 347403 0
Pre-intervention commencement and 7 days post-intervention completion
Secondary outcome [4] 347464 0
Change to child school achievement measured via parent-report of school awarded grades achieved in English, mathematics, science, humanities and social sciences or via parent estimate of achievement (above average, average, below average) for school-age children who do not receive formal grades.
Timepoint [4] 347464 0
Baseline - 6 months - 12 months - 24 months
Secondary outcome [5] 347674 0
Change to parent attention deficit/hyperactivity problems as assessed by the Adult Self-Report (ASR) (this is a primary outcome)
Timepoint [5] 347674 0
Baseline and 6 (primary time-point), 12 and 24 months post baseline
Secondary outcome [6] 347675 0
Change to parent antisocial personality problems as assessed by the Adult Self-Report (ASR) (this is a primary outcome)
Timepoint [6] 347675 0
Baseline and 6 (primary time-point), 12 and 24 months post baseline
Secondary outcome [7] 347676 0
Change to child depressive problems as assessed by the Child Behavior Checklist (this is a primary outcome)
Timepoint [7] 347676 0
Baseline and 6 (primary time-point), 12 and 24 months post baseline
Secondary outcome [8] 347677 0
Change to child anxiety problems as assessed by the Child Behavior Checklist (this is a primary outcome)
Timepoint [8] 347677 0
Baseline and 6 (primary time-point), 12 and 24 months post baseline
Secondary outcome [9] 347678 0
Change to child attention deficit/hyperactivity problems as assessed by the Child Behavior Checklist (this is a primary outcome)
Timepoint [9] 347678 0
Baseline and 6 (primary time-point), 12 and 24 months post baseline
Secondary outcome [10] 347679 0
Change to child autism spectrum problems as assessed by the Child Behavior Checklist (this is a primary outcome)
Timepoint [10] 347679 0
Baseline and 6 (primary time-point), 12 and 24 months post baseline
Secondary outcome [11] 347680 0
Change to child oppositional defiant problems as assessed by the Child Behavior Checklist (this is a primary outcome)
Timepoint [11] 347680 0
Baseline and 6 (primary time-point), 12 and 24 months post baseline
Secondary outcome [12] 347681 0
Change to child conduct problems as assessed by the Child Behavior Checklist (this is a primary outcome)
Timepoint [12] 347681 0
Baseline and 6 (primary time-point), 12 and 24 months post baseline
Secondary outcome [13] 347683 0
Change to child social problems as assessed by parent reported occurrence of child being bullied in previous month and frequency of child being rejected by peers in the previous month.
Timepoint [13] 347683 0
Baseline - 6 months - 12 months - 24 months
Secondary outcome [14] 347689 0
Change to number of parent-reported organized child leisure activities engaged in over the previous month (e.g. scouts, sports, music lessons, religious classes).
Timepoint [14] 347689 0
Baseline - 6 months - 12 months - 24 months
Secondary outcome [15] 347690 0
Change to parent reported duration of child screen-time (Rarely or never, Less than one hour per week, 1-3 hours per week, 4-7 hours per week, 1-2 hours per day, 3-6 hours per day, More than 6 hours per day)
Timepoint [15] 347690 0
Baseline - 6 months - 12 months - 24 months
Secondary outcome [16] 347691 0
Change to child (school-age children) autistic traits as assessed by the Social Responsiveness Scale Short Form (SRS -Short) (This is a primary outcome)
Timepoint [16] 347691 0
Baseline and 6 (primary timepoint), 12 and 24 months post baseline

Eligibility
Key inclusion criteria
Parents participating in "Improving outcomes in mental health: A longitudinal clinical study of vulnerable families" who score above the (sub)clinical threshold on the ASR at baseline (indicating possible mental health problems) are eligible for this trial. Participants of the longitudinal study are adults and children from families that have been referred to the Child Development Program in Children's Health Queensland, Health and Hospital Service.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The broader longitudinal study from which participants are recruited excludes parents who have insufficient English and/or literacy to complete assessment. Families who live large geographical distances from the program delivery site (Queensland Children's Hospital) and therefore are unable to attend program sessions, will be excluded from the trial

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (blocks of 10) using a randomisation table created by computer software
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
140 families in each arm is sufficient to be able to detect an effect size of 0.30 on the ASR and CBCL with an alpha of 0.05 with 80% power, Recruiting 150 families per arm will allow for some attrition. Structural equation modelling will be used to assess any effect of the intervention. In the first analysis, we will test whether the intervention lowers the T2 (6months) and T3 (24 months) scores. The analytic plan uses an intent-to-treat approach, including data for all participants who completed T1 and were randomised, regardless of whether they commenced, completed the intervention, or completed T2 or T3. The effect of the intervention on child and parental outcomes at 6 months and one year after baseline will be analysed simultaneously. Associations between parent-offspring measures at each time-point will be taken into account as well as predictions by earlier assessments and by sex and age.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13911 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 22795 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 299527 0
Charities/Societies/Foundations
Name [1] 299527 0
Children's Hospital Foundation
Address [1] 299527 0
C/- Queensland Children’s Hospital 501 Stanley Street South Brisbane Queensland 4101
Country [1] 299527 0
Australia
Funding source category [2] 299618 0
University
Name [2] 299618 0
The University of Queensland
Address [2] 299618 0
St Lucia, Brisbane
Queensland, 4072
Country [2] 299618 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Child Health Research Centre
The University of Queensland
The Centre for Children's Health Research
62 Graham St, South Brisbane, 4101
Country
Australia
Secondary sponsor category [1] 298827 0
Hospital
Name [1] 298827 0
Children's Health Queensland, Health and Hospital Service
Address [1] 298827 0
Queensland Children's Hospital 501 Stanley Street, South Brisbane Queensland 4101
Country [1] 298827 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300424 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 300424 0
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 300424 0
Australia
Date submitted for ethics approval [1] 300424 0
25/08/2017
Approval date [1] 300424 0
31/10/2017
Ethics approval number [1] 300424 0
HREC/17/QRCH/203
Ethics committee name [2] 300502 0
The University of Queensland Human Research Ethics Committes A & B
Ethics committee address [2] 300502 0
Human Ethics Research Office
Cumbrae-Stewart Building #72
The University of Queensland
St Lucia, Qld, 4072
Ethics committee country [2] 300502 0
Australia
Date submitted for ethics approval [2] 300502 0
22/11/2017
Approval date [2] 300502 0
23/11/2017
Ethics approval number [2] 300502 0
2017001886

Summary
Brief summary
The aim of this study is to determine if an evidence-based parenting program which also teaches skills to cope with everyday stress (Enhanced Stepping Stones Triple P) is more effective than a parenting program alone (Stepping Stones Triple P) in improving the mental wellbeing of both parents and children who experience mental health challenges. For adults, mental health challenges include symptoms of depression, anxiety, hyperactivity, and substance abuse. For children, mental health challenges may include symptoms of depression and anxiety as well as developmental issues including symptoms of attention deficit/hyperactivity, autistic traits and conduct problems.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83622 0
Prof Christel Middeldorp
Address 83622 0
Child Health Research Centre
The University of Queensland
Level 6
Centre for Children's Health Research (CCHR)
62 Graham Street
South Brisbane QLD 4101, Australia
Country 83622 0
Australia
Phone 83622 0
+61 7 3069 7595
Fax 83622 0
Email 83622 0
c.middeldorp@uq.edu.au
Contact person for public queries
Name 83623 0
Dr Leanne Winter
Address 83623 0
Child Health Research Centre
The University of Queensland
Level 6
Centre for Children's Health Research (CCHR)
62 Graham Street
South Brisbane QLD 4101, Australia
Country 83623 0
Australia
Phone 83623 0
+61 7 3069 7453
Fax 83623 0
Email 83623 0
l.winter@uq.edu.au
Contact person for scientific queries
Name 83624 0
Prof Christel Middeldorp
Address 83624 0
Child Health Research Centre
The University of Queensland
Level 6
Centre for Children's Health Research (CCHR)
62 Graham Street
South Brisbane QLD 4101, Australia
Country 83624 0
Australia
Phone 83624 0
+61 7 3069 7595
Fax 83624 0
Email 83624 0
c.middeldorp@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication with no end date presently determined.
Available to whom?
Other researchers who have specifically applied to the Principal Investigator and whose projects have appropriate Human Research Ethics committee approval. To be decided on a case by case basis by the Principal Investigator.
Available for what types of analyses?
Analyses necessary to achieve the aims of the HREC approved project.
How or where can data be obtained?
Undecided at this time but will involve having to contact the Principal Investigator and the requirement to sign a data access agreement.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 2138 0
Study protocol
Citation [1] 2138 0
Link [1] 2138 0
Email [1] 2138 0
Other [1] 2138 0
Summary results
No Results