Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000779673
Ethics application status
Approved
Date submitted
10/07/2014
Date registered
21/07/2014
Date last updated
21/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating a workshop for divorced or separated parents with children aged between 2 and 12 years.
Scientific title
A randomised controlled trial comparing a Family Transitions Triple P Workshop and a control group, on child behaviour and parenting practices, in separated or divorced parents with children aged between 2 to 12 years of age.
Secondary ID [1] 284942 0
Nil
Universal Trial Number (UTN)
U1111-1159-0534
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child behavioural problems 292426 0
Parenting practices 292427 0
Co-parental conflict 292428 0
Social support 292429 0
Parental adjustment 292430 0
Parenting confidence and self-efficacy 292431 0
Condition category
Condition code
Public Health 292739 292739 0 0
Health promotion/education
Mental Health 292740 292740 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Triple P is a multilevel system of behavioural family interventions that aims to prevent and treat child social, emotional and behavioural problems by enhancing parenting confidence, knowledge and skills. Triple P offers five levels of intervention varying in the degree and type of parental support required. The current intervention is classified as Level 2 (seminars).

Within the Triple P system, Family Transitions Triple P was developed specifically for who are separated or divorced. Parents in the intervention group will participate in a 4 hour seminar on successfully navigating the transition through divorce. The seminar will describe the needs of children following divorce, provide an understanding of the transition of divorce, and help parents identify factors that play a role in causing problems for children following divorce. The intervention also aims to teach positive parenting skills, reduce conflict between parents over parenting issues, improve communication with children and build parents' stress management and coping skills.

A randomised controlled trial design will be used to evaluate the effects of participation in the seminar intervention, in comparison with a wait list control group.
Intervention code [1] 289792 0
Behaviour
Intervention code [2] 289793 0
Prevention
Comparator / control treatment
The wait list control group will receive no intervention during the actual study, however will be provided with the Family Transitions Seminar approximately 3 months after the intervention group has completed the intervention, after the study has been completed and all data has been collected.
Control group
Active

Outcomes
Primary outcome [1] 292591 0
Child emotional and behavioural problems assessed using the Child Adjustment and Parent Efficacy Scale (CAPES; Morawska & Sanders, 2010).
Timepoint [1] 292591 0
Baseline, 6 weeks post-intervention, 3 months post-intervention
Primary outcome [2] 292592 0
Parenting practices assessed using the Parenting and Family Adjustment Scale (PAFAS; Sanders, Morawska, Haslam, Filus & Fletcher, 2013)
Timepoint [2] 292592 0
Baseline, 6 weeks post-intervention, 3 months post-intervention
Secondary outcome [1] 309283 0
Co-parental conflict assessed using the Acrimony Scale (Emery, 1982)
Timepoint [1] 309283 0
Baseline, 6 weeks post-intervention, 3 months post-intervention
Secondary outcome [2] 309284 0
Social support as assessed by the Personal Resource Questionnaire (PRQ) (Weinert, 1987)
Timepoint [2] 309284 0
Baseline, 6 weeks post-intervention, 3 months post-intervention
Secondary outcome [3] 309285 0
Parental adjustment as assessed by the Depression Anxiety Stress Scales (DASS; Lovibond & Lovibond, 1995).
Timepoint [3] 309285 0
Baseline, 6 weeks post-intervention, 3 months post-intervention
Secondary outcome [4] 309286 0
Client Satisfaction as assessed by the Parent Satisfaction Survey (Sanders & Turner, 2005).
Timepoint [4] 309286 0
3 months post-intervention

Eligibility
Key inclusion criteria
A parent who has at least one child between the ages of 2 and 12.

The parent has been separated from their partner for no more than two years - this includes being divorced for no more than one year.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The parent has been separated from their partner for longer than two years.

The target child has a disability and/or chronic illness, including language or speech impairment.

The parent is currently seeing a professional for parenting support, primarily relating to their child’s behaviour difficulties.

The parent is currently enrolled in a parenting program or attended a parenting program in the past 3 months.

The parent is receiving psychological/psychiatric help or counselling (personal/marital).

The parent is intellectually and/or hearing impaired.

The parent is not able to read/write English without assistance.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Parents interested in participating in the study are asked to contact the researcher for further information about the study protocol. After initial contact, parents will complete a brief telephone screening interview to ensure the inclusion and exclusion criteria are met and therefore confirm participant eligibility. A participant information sheet and consent form will be provided online for the parent before they can access the survey. Informed consent will be obtained online before the pre-intervention measures can be completed. Randomisation to conditions will be conducted after the participant's completion of pre-intervention measures.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to the intervention, participants will be randomly assigned to the intervention or waitlist control conditions using a pre-generated computerised number sequence, administered by a research assistant, to ensure that the researcher is blind to group assignment.
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
A priori power analysis was performed using G*Power software to determine a reasonable sample size for the study. Sample size was determined based on repeated-measures MANOVA with interactions, with two primary outcomes and three measurement time points (number of measurements = 6). An effect size of 0.25 was set, based on previous level 2 Triple P trials. Consistent with convention a Type I error rate of 0.05 was used, along with Power of 0.8, yielding a total sample size of 158 participants.
Initial comparisons of the control and treatment groups at baseline will be performed using analysis of variance and chi-square tests. This is to ensure adequate randomization in that there were no significant differences between demographic variables or outcome variables prior to the intervention. This also includes chi-square test significant differences in rates of attrition between the intervention and waitlist control group.

Short-term intervention effects will be measured using univariate ANCOVA’s & MANCOVAS. Differences at baseline will be used as covariates in the analyses to control for any differences and therefore reduce error. Cohen’s d will be used to measure the effect sizes in order to report the magnitude of relationships. Means and standard deviations will also be reported, in particular for reporting the results of the measure of intervention acceptability. Clinically reliable change will be calculated to determine how much change was caused by the intervention. A change exceeding 1.96 times the standard error will be considered a statistically reliable change.

Long-term intervention effects will be measure using ANOVAs and MANOVAs. Repeated measures MANOVAs will be used to compare pre-intervention and follow-up effects for the intervention group across child and parent variables. Univariate ANOVAs will be used to measure across variables with a significant multivariate effect.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 289571 0
University
Name [1] 289571 0
University of Queensland
Country [1] 289571 0
Australia
Primary sponsor type
Individual
Name
Jenna Campbell
Address
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia, QLD
4072
Country
Australia
Secondary sponsor category [1] 288253 0
None
Name [1] 288253 0
Address [1] 288253 0
Country [1] 288253 0
Other collaborator category [1] 278043 0
Individual
Name [1] 278043 0
Prof Matthew R. Sanders
Address [1] 278043 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia, QLD
4072
Country [1] 278043 0
Australia
Other collaborator category [2] 278044 0
Individual
Name [2] 278044 0
Dr Helen Stallman
Address [2] 278044 0
University of South Australia
Magill Campus
Adelaide, South Australia
5001
Country [2] 278044 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291321 0
University of Queensland School of Psychology Student Research Ethics Review
Ethics committee address [1] 291321 0
Ethics committee country [1] 291321 0
Australia
Date submitted for ethics approval [1] 291321 0
Approval date [1] 291321 0
24/03/2014
Ethics approval number [1] 291321 0
14-PSYCH-MCP-08-AH

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

Contacts
Principal investigator
Name 49522 0
Ms Jenna Campbell
Address 49522 0
Parenting and Family Support Centre School of Psychology The University of Queensland St Lucia Brisbane QLD 4072
Country 49522 0
Australia
Phone 49522 0
+61 (7) 3365 7290
Fax 49522 0
Email 49522 0
[email protected]
Contact person for public queries
Name 49523 0
Jenna Campbell
Address 49523 0
Parenting and Family Support Centre School of Psychology The University of Queensland St Lucia Brisbane QLD 4072
Country 49523 0
Australia
Phone 49523 0
+61 (7) 3365 7290
Fax 49523 0
Email 49523 0
[email protected]
Contact person for scientific queries
Name 49524 0
Jenna Campbell
Address 49524 0
Parenting and Family Support Centre School of Psychology The University of Queensland St Lucia Brisbane QLD 4072
Country 49524 0
Australia
Phone 49524 0
+61 (7) 3365 7290
Fax 49524 0
Email 49524 0
[email protected]

No information has been provided regarding IPD availability


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.