Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000986370
Ethics application status
Approved
Date submitted
19/06/2017
Date registered
10/07/2017
Date last updated
13/06/2019
Date data sharing statement initially provided
13/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Building Bridges Triple P: A new parenting program for parents of teens with a developmental disorder aimed at offering parents strategies to deal with emotional and behavioural problems in their children.
Scientific title
Building Bridges Triple P: A Control Trial of a Behavioural Family Intervention for Parents of Adolescents with a Developmental Disorder
Secondary ID [1] 292023 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 303417 0
Down Syndrome 303815 0
Cerebral Palsy 303816 0
Attention Deficit Hyperactivity Disorder 303817 0
Specific Language Disorder 313261 0
Condition category
Condition code
Human Genetics and Inherited Disorders 302827 302827 0 0
Down's syndrome
Mental Health 302828 302828 0 0
Autistic spectrum disorders
Musculoskeletal 302829 302829 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Building Bridges Triple P (BBTP) is a parenting program which aims to promote parent skills and reduce parent reported behavioural and emotional problems of adolescents with a developmental disorder, addressing relationships within the family, and improving outcomes for teens and parents. The sample will therefore consist of parents who have an adolescent child with a developmental disability such as Autism Spectrum Disorder, Down Syndrome, Cerebral Palsy, Attention-Deficit-Hyperactivity Disorder and others. Eligible participants will be asked to complete the pre-measures in an online format. They will also be asked to complete these questionnaires again at two predetermined times following the Building Bridges program (post-measures). The questionnaires are estimated to take participants approximately 30-45 minutes to complete.

After questionnaires are completed, participants (parents) will be allocated to either the intervention group (IG) or the waitlist control group (WCG). This allocation is not random. Participants are not allocated based on any criteria. A group is predetermined as either intervention or control and as participants express interest and availability they are put into one of the groups based on the next group which is running. Participants in the IG will initially complete the Building Bridges Triple P program consisting of five 120-minute face-to-face group sessions and three 30-minute follow-up telephone sessions held once per week following the 5 face-to-face sessions. Phone sessions will also be held with the lead researcher and aim to check in with how participants are progressing with implementing the program strategies and assist them in problem solving any issues or barriers in the implementation of the strategies/skills. All sessions (group face-to-face and individual telephone sessions) are held over eight consecutive weeks. The program is manualised and topics covered include understanding teenager’s behaviour, promoting positive parenting behaviours and assisting teenagers to manage their emotions. Each participant will receive a workbook (Ralph, Mazzucchelli, & Sanders, 2016) outlining key learning principles covered in each session. All sessions will be facilitated by the lead researcher (a postgraduate provisional clinical psychologist) and trained postgraduate clinical psychology students at the University of Queensland. At the completion of the eight-week program, IG participants will complete the post-measures. At 2 months’ post intervention, participants in the IG will then complete the follow-up measures.

Intervention adherence will be monitored via participant reported monitoring with monitoring worksheets provided as part of the program. During the 3 phone sessions, researchers will discuss intervention adherence with participants and any difficulties participants may be having with adherence.

Intervention fidelity will be ensured as all facilitators will receive training in the program and regular supervision with Associate Professor Kate Sofronoff, and there will be a fidelity checklist for each session. Required improvements in fidelity will be discussed with the supervisor and addressed accordingly.
Intervention code [1] 298155 0
Behaviour
Comparator / control treatment
Participants in the WCG will complete the Time 2 measure prior to commencing the program,
approximately 8 weeks after completing the pre-measure. The WCG will complete the Building Bridges Triple P program in the exact same structure as the IG program. This will also be facilitated by the lead researcher and trained postgraduate clinical psychology students. At the completion of the eight-week program, participants in the WCG will complete the Time 3 measure. IG scores at pre- and post-intervention will be compared. Follow-up scores will be analysed to assess for maintenance effects. IG scores at post-intervention will be compared to WCG scores at pre-intervention to assess treatment effects.
Control group
Active

Outcomes
Primary outcome [1] 302283 0
The Child Adjustment and Parent Efficacy Scale- Developmental Disability was used to assess family functioning and child outcomes.
Timepoint [1] 302283 0
T1: Baseline T2: at the immediate completion of the program T3: 2 months after completion of the program
Primary outcome [2] 302285 0
Parenting Style as assessed by self-reported score on the Parenting Scale.
Timepoint [2] 302285 0
T1: Baseline T2: at the immediate completion of the program T3: 2 months after completion of the program
Primary outcome [3] 302286 0
Parenting efficacy in relation to child behaviour and emotional problems as assessed by self-report on the Child Adjustment and Parent Efficacy Scale-Developmental Disability.
Timepoint [3] 302286 0
T1: Baseline T2: at the immediate completion of the program T3: 2 months after completion of the program
Secondary outcome [1] 335359 0
Mean Depression scores of parents on the Depression, Anxiety and Stress Scale-21.
Timepoint [1] 335359 0
T1: Baseline T2: at the immediate completion of the program T3: 2 months after completion of the program
Secondary outcome [2] 335360 0
Child behaviour change (specific target behaviour selected by parents) over time as assessed by the Goal Achievement Scales
Timepoint [2] 335360 0
T1: Baseline T2: at the immediate completion of the program T3: 2 months after completion of the program
Secondary outcome [3] 335361 0
Client satisfaction of the program as assessed by the Client Satisfaction and Strategies Questionnaires completed by parents.
Timepoint [3] 335361 0
At the immediate completion of the program
Secondary outcome [4] 336436 0
Mean Anxiety scores of parents on the Depression, Anxiety and Stress Scale-21.
Timepoint [4] 336436 0
T1: Baseline T2: at the immediate completion of the program T3: 2 months after completion of the program
Secondary outcome [5] 336437 0
Mean Stress scores of parents on the Depression, Anxiety and Stress Scale-21.
Timepoint [5] 336437 0
T1: Baseline T2: at the immediate completion of the program T3: 2 months after completion of the program
Secondary outcome [6] 371465 0
Parental Relationship Satisfaction measured via the Relationship Quality Index
Timepoint [6] 371465 0
Baseline pre-program, immediately post completion of intervention and 2 month Follow-up after completion of program
Secondary outcome [7] 371466 0
Co-parenting satisfaction/functioning measured via the Parent Problem Checklist
Timepoint [7] 371466 0
Baseline pre-program, immediately post completion of intervention and 2 month Follow-up after completion of program

Eligibility
Key inclusion criteria
Participants will be parents of teenagers with a Developmental Disability who will be recruited to participate. The sample will consist of parents who have an adolescent child with a developmental disability such as Autism Spectrum Disorder, Down Syndrome, Cerebral Palsy, Attention-Deficit-Hyperactivity Disorder and others. The inclusion criteria include parents who have an adolescent child with a Developmental Disability and that these children be aged between 12 and 18 years old. It is not a requirement that participating families have a two-parent arrangement.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
It is a requirement that participants are not participating in other parenting interventions simultaneously.

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)
Randomisation no longer occurring. Allocation of participants is known by lead researcher but allocation occurs before the researcher meets the participants or knows any personal information about them to reduce bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation no longer occurring.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Both the intervention group and wait-list control group receive the same intervention (the Building Bridges Program) although the wait-list control group receives this immediately after the IG finishes the program (8 weeks after completing the Time 1 measure).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations:
Effect size (based on similar study by Whittingham, Sofronoff, Sheffield & Sanders, 2009): 0.16
Power level: 0.8
IVs: 1
Probability level: 0.05
Minimum required sample size: 50

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/05/2017
Date of last participant enrolment
Anticipated
Actual
15/12/2018
Date of last data collection
Anticipated
Actual
30/04/2019
Sample size
Target
50
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 296554 0
University
Name [1] 296554 0
The University of Queensland
Country [1] 296554 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Kate Sofronoff
Address
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 295504 0
University
Name [1] 295504 0
The University of Queensland
Address [1] 295504 0
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country [1] 295504 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297768 0
School of Psychology Ethics Committee- The University of Queensland
Ethics committee address [1] 297768 0
Ethics committee country [1] 297768 0
Australia
Date submitted for ethics approval [1] 297768 0
18/04/2017
Approval date [1] 297768 0
24/04/2017
Ethics approval number [1] 297768 0
17-PSYCH-PHD-23-JS

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1748 1748 0 0
/AnzctrAttachments/373000-PARTICIPANT INFORMATION STATEMENT .pdf (Participant information/consent)
Attachments [2] 1749 1749 0 0
/AnzctrAttachments/373000-CONSENT FORM.pdf (Participant information/consent)

Contacts
Principal investigator
Name 75058 0
Miss Tahlia Gash
Address 75058 0
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 75058 0
Australia
Phone 75058 0
+61 423333160
Fax 75058 0
Email 75058 0
[email protected]
Contact person for public queries
Name 75059 0
Tahlia Gash
Address 75059 0
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 75059 0
Australia
Phone 75059 0
+61 423333160
Fax 75059 0
Email 75059 0
[email protected]
Contact person for scientific queries
Name 75060 0
Tahlia Gash
Address 75060 0
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 75060 0
Australia
Phone 75060 0
+61 423333160
Fax 75060 0
Email 75060 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


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.