Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000692639
Ethics application status
Approved
Date submitted
20/06/2014
Date registered
2/07/2014
Date last updated
2/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a brief parenting discussion group for parents of 3-8 year old children with a disability.
Scientific title
A randomised controlled trial evaluating the efficacy of Stepping Stones Triple P Discussion Group (Dealing with Disobedience topic) with parents of children with a disability, aged between 3 to 8 years of age.
Secondary ID [1] 284837 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child behavioural problems 292227 0
Parenting practices 292299 0
Parenting mental health 292300 0
Parenting confidence and self-efficacy 292301 0
Condition category
Condition code
Public Health 292564 292564 0 0
Health promotion/education
Mental Health 292565 292565 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Triple P is a multi-level parenting and family support program that aims to provide parents with a range of strategies to promote parental confidence, skills and knowledge, reducing the risk of behavioural, emotional and developmental problems in children. It incorporates five tiered levels of intervention varying according to the level of intensity, practitioner contact, and delivery format; from universal, media-based programs (Level 1; Universal Triple P), brief selective intervention (Level 2; Selected Triple P), narrow focused parent training (Level 3; Primary Care Triple P), broad focused parent training (Level 4; Standard Triple P), to intensive family intervention programs (Level 5; Enhanced Triple P). The core principles that underpin Triple P include: (a) Having a safe interesting environment; (b) having a positive learning environment; (c) using assertive discipline; (d) having realistic expectations; and (e) taking care of yourself as a parent.

Within the Triple P system, Stepping Stones Triple P (SSTP) was developed specifically for parents of children with developmental disabilities. SSTP involves standard Triple P principles, as well as additional strategies derived from the literature for children with disabilities. Adaptations include making the strategies more sensitive to the unique challenges that families of children with disabilities face, including pertinent material related to disabilities, such as adjustment to having a child with a disability, parents’ increased care giving role, inclusion and community living, and family and friend support, as well as behaviour change procedures for commonly encountered problems (e.g., self-injurious behaviour, repetitive behaviours and pica). Strategies such as blocking, physical guidance, activity schedules, and functional communication training are also taught to parents.

Triple P Discussion Group is a new Level 3 intervention, and includes specific parent discussion groups on four commonly encountered problems. The discussion groups are designed to provide an overview of the positive parenting principles inherent within Triple P, with parents being actively involved throughout the one two-hour small group discussions.

This discussion group session will specifically address the issue of how to manage child disobedience. An accredited Triple P facilitator will run the session. Other parents with similar concerns about their child's disobedience will also attend. The program will use a mix of video demonstrations, discussion, practice and home based activities. The program is free and parents will also receive a free Stepping Stones Triple P - A Guide to Disruptive Behaviour booklet.

Specific topic of discussion will include:
*Common forms of disobedience
*Identifying parenting traps
*Reasons why children are disobedient
*How to prevent disobedience
*How to teach children to follow instructions
*Setting management plans

One telephone consultation with a Triple P accredited practitioner will be added to the session in order to enhance parental problem solving, self-regulation and parenting skills. This telephone session will take at least 10 minutes, but not more than 30 minutes, and will take place four weeks after the session.

A randomised controlled trial design will be used to evaluate the effects of participation in the discussion group intervention, in comparison with a wait list control group.
Intervention code [1] 289632 0
Behaviour
Intervention code [2] 289633 0
Prevention
Comparator / control treatment
The wait list control group will receive no intervention during the actual study, however will be provided with the Stepping Stones Discussion Group intervention approximately 4 weeks 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] 292427 0
A decrease in the number of child problem behaviours. Measured by parent report scores on the Eyberg Child Behaviour Inventory (ECBI), Child Emotional and Behavioural Problems Scale on the Child Adjustment and Parent Efficacy Scale—Developmental Disability (CAPES-DD), and behavioural monitoring record form (e.g., "keeping track of disobedience chart).
Timepoint [1] 292427 0
Pre-intervention, post-intervention, and at 4 weeks follow up (i.e., 4 weeks after completion of the intervention).
Secondary outcome [1] 308916 0
Reduction in dysfunctional parenting practices (i.e., laxness, over reactivity, and verbosity). Measured by parent report scores on The Parenting Scale (PS).
Timepoint [1] 308916 0
Pre-intervention, Post-intervention, and at 4 weeks follow-up.
Secondary outcome [2] 308917 0
Decrease in symptoms of depression, anxiety and stress reported by parents. Measured by parent report results on The Depression, Anxiety and Stress Scale (i.e., DASS).
Timepoint [2] 308917 0
Pre-intervention, Post-intervention, and at 4 weeks follow-up.
Secondary outcome [3] 308918 0
Increase in parental confidence and efficacy. Measured by parent report scores on the Parent Efficacy Scale on The Child Adjustment and Parent Efficacy Scale—Developmental Disability (CAPES-DD).
Timepoint [3] 308918 0
Pre-intervention, Post-intervention, and at 4 weeks follow-up.
Secondary outcome [4] 308919 0
Parent satisfaction with the intervention. Measured by parent report Triple P discussion group satisfaction Questionnaire.
Timepoint [4] 308919 0
Post-intervention (at the end of the discussion group session).
Secondary outcome [5] 308920 0
Treatment fidelity measured by the Triple P Discussion Group session checklist.
Timepoint [5] 308920 0
The checklists will be completed by the Triple P practitioner at the end of the group session. All Triple P discussion groups will be videotaped and approximately 25% of recordings will be randomly assessed by an independent observer and treatment fidelity will be recorded using the same session checklist.

Eligibility
Key inclusion criteria
Parents has a child between the ages of 3 and 8 years of age.

Parents have a child with a diagnosed disability, including autism spectrum disorder, cerebral palsy, Down syndrome, fragile X syndrome, or intellectual disability.

Parents who report that their child is displaying problem behaviour, including disobedience. Parents who also report difficulties in managing this behaviour and are wanting to attend a parent group to learn new parenting skills.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parent who is currently seeing a professional for their child's behavioural difficulties or if they have attended a Triple P parenting program in the last one month (rationale: if the target child or parent is receiving support from another service, then it will be difficult to disentangle potential benefits gained from the provided intervention than from those gained from the external support).

Parents with current major psychopathology, including those who meet the criteria for schizophrenia, bipolar disorder, and high suicidality risk. (rationale: if parents are currently experiencing high distress levels it may be difficult for them to engage successfully in the parent discussion group and achieve positive outcomes).

Parents who are not able to read without assistance (rationale: the written materials and discussion-based format of the intervention is not suitable for parents who cannot read without assistance).

Parents who do not meet the inclusion criteria will be provided with alternative service provider information and contact details.

Study design
Purpose of the study
Educational / counselling / training
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 given to parents, and written informed consent will be obtained and pre-intervention measures will be completed. Randomisation to condition will be conducted in sequence of 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
Other
Other design features
A randomised group comparison design will be used with two conditions (intervention and waitlist control) and three time periods (pre-intervention, post-intervention and 4 weeks follow up).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analysis indicates that for a large effect size of 0.8 (predicted based on previous Stepping Stones Triple P research) it will be necessitate recruiting a total of 52 participants. To account for attrition rates of around 20%, a sample of 62 will be targeted, with 31 participants in each group (i.e., intervention and wait-list control).

As a preliminary analysis of the data, a series of repeated MANOVAs will be conducted to determine whether any pre-intervention differences exist between the intervention and waitlist control group.

Intervention effects will be analysed using a series of repeated measures multivariate (MANCOVAs) and univariate analyses of covariance (ANCOVAs). Pre-intervention scores will be used as covariates and post-intervention scores will be the dependent variables. MANCOVAs will be completed on each set of conceptually related dependent variables: child behaviour (ECBI, CAPES-DD, Keeping Track Chart), parenting and parental adjustment (PS, DASS-21).

Violation of assumptions will be checked and assessed at an alpha level of .05. The assumption of normality will be determined by looking at the Skewness and Kurtosis statistics. Homogeneity of variance will be assessed by using the Levene’s Test for Equality of Error Variance and the assumption of sphericity will be evaluated using Mauchly’s Test of Sphericity. To correct for the number of analyses a Bonferroni adjustment will be computed.

The Reliable Change Index will also be compute to determine how many participants reliably improved on each measure. Clinical significance of change will be calculated to indicate whether participants moved out of the clinical range from pre-intervention to post-intervention using published clinical cut off scores. The proportion of participants who clinically improve will be recorded. Chi-square analyses will be performed on the reliably improved and clinically improved data.

SPSS will be used to conduct the analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 8317 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 289448 0
University
Name [1] 289448 0
School of Psychology & Speech Pathology Research Award Grant. Curtin University. Bentley. Western Australia.
Country [1] 289448 0
Australia
Primary sponsor type
University
Name
School of Psychology and Speech Pathology. Curtin University.
Address
Kent Street, Bentley, Perth
Western Australia 6102
Country
Australia
Secondary sponsor category [1] 288135 0
None
Name [1] 288135 0
Address [1] 288135 0
Country [1] 288135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291206 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291206 0
Ethics committee country [1] 291206 0
Australia
Date submitted for ethics approval [1] 291206 0
Approval date [1] 291206 0
16/06/2014
Ethics approval number [1] 291206 0

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

Contacts
Principal investigator
Name 49338 0
Dr Trevor Mazzucchelli
Address 49338 0
Curtin University Kent Street, Bentley, Perth Western Australia 6102
Country 49338 0
Australia
Phone 49338 0
+61 8 9266 7182
Fax 49338 0
Email 49338 0
[email protected]
Contact person for public queries
Name 49339 0
Karla Cloke
Address 49339 0
Curtin University Kent Street, Bentley, Perth Western Australia 6102
Country 49339 0
Australia
Phone 49339 0
+61 8 9266 3436
Fax 49339 0
Email 49339 0
[email protected]
Contact person for scientific queries
Name 49340 0
Trevor Mazzucchelli
Address 49340 0
Curtin University Kent Street, Bentley, Perth Western Australia 6102
Country 49340 0
Australia
Phone 49340 0
+61 8 9266 7182
Fax 49340 0
Email 49340 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.