Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000100796
Ethics application status
Approved
Date submitted
22/01/2013
Date registered
25/01/2013
Date last updated
29/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of brief parenting discussion groups for parents with 5-8 year old children.
Scientific title
A randomised controlled trial evaluating brief parenting discussion groups for parents with 5-8 year old children at risk of developing conduct problems.
Secondary ID [1] 281558 0
Nil
Universal Trial Number (UTN)
U1111-1137-0993
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child behaviour 287840 0
Parenting practices
 287852 0
Condition category
Condition code
Public Health 288183 288183 0 0
Health promotion/education
Mental Health 288184 288184 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Triple P Discussion Groups are preventively focused interventions designed to provide specific advice about common child behaviour or developmental issues. During the two-hour group sessions, parents are taught about the principles of positive parenting, strategies for developing a good parent-child relationship, and strategies for managing specific problem behaviours. These strategies are alternatives to coercive and ineffective discipline strategies. All discussion groups involve video-modelling of behaviour management strategies, a tailored implementation plan, and training in planned activities routines to cope with high-risk situations. The format of the group session includes some didactic presentations, active skills training, and group discussions. Each discussion group is accompanied by a workbook.
The Triple P Discussion Groups used in this study will focus on five different topic areas: Dealing with Disobedience, Being a Positive Parent, Fighting and Aggression, Doing Chores, and Building Self-Esteem. The Dealing with Disobedience Triple P Discussion Group focuses on reasons for disobedience, parenting traps, ways to encourage positive child behaviour and strategies for dealing with disobedience. During the Being a Positive Parent group parents are introduced to the principles of positive parenting and taught a range of skills aimed at assist them to support their child’s competence and development and to build a positive relationship with their child. The Fighting and Aggression session covers why children fight, skills to teach children to play cooperatively, and strategies for dealing with sibling conflict, fighting, not sharing, and aggression. During the Doing Chores group parents will learn why helping is important, strategies to help prepare and encourage children to do chores, as well as strategies to use when chores are not completed. The Building Self-Esteem session looks at causes of low self-esteem, and teaches strategies to encourage healthy self-esteem, and to help children to manage negative self-talk and solve problems.

Arm 1
Participants allocated to the one-off discussion group condition will receive the Dealing with Disobedience Triple P Discussion Group only.

Arm 2
Participants allocated to the series of four group sessions will receive the Dealing with Disobedience and Being a Positive Parent Triple P Discussion Groups. They will then be given the choice to attend two additional groups targeting other specific behaviours and concerns, out of the three following topics: Fighting and Aggression, Doing Chores, and Building Self-Esteem. Parents attended four sessions once a week over a period of 4 to 5 weeks.
Intervention code [1] 286074 0
Behaviour
Intervention code [2] 286389 0
Prevention
Comparator / control treatment
The comparison group for the trial is the one-off discussion group condition, described above in Arm 1.
Control group
Active

Outcomes
Primary outcome [1] 288383 0
Child behaviour problems as measured by the two scales of the Eyberg Child Behavior Inventory (ECBI) parent-report questionnaire.
Timepoint [1] 288383 0
Pre-intervention, post-intervention, and 6-month follow-up.
Secondary outcome [1] 300005 0
Child behaviour problems as measured by the five subscales of the parent-report Strengths and Difficulties Questionnaire (SDQ).
Timepoint [1] 300005 0
Pre-intervention, post-intervention, and 6-month follow-up.
Secondary outcome [2] 300006 0
Child behaviour problems as measured by the Parent Daily Report (PDR) questionnaire.
Timepoint [2] 300006 0
Pre-intervention, post-intervention, and 6-month follow-up.
Secondary outcome [3] 300007 0
Dysfunctional parenting practices as measured by the three subscales of The Parenting Scale (PS) self-report questionnaire.
Timepoint [3] 300007 0
Pre-intervention, post-intervention, and 6-month follow-up.
Secondary outcome [4] 300055 0
Parenting self-efficacy as measured by the two subscales of the Parenting Tasks Checklist (PTC) self-report questionnaire.
Timepoint [4] 300055 0
Pre-intervention, post-intervention, and 6-month follow-up.
Secondary outcome [5] 300636 0
Parenting experiences as measured by the Parenting Experience Survey (PES) self-report questionnaire.
Timepoint [5] 300636 0
Pre-intervention, post-intervention, and 6-month follow-up.
Secondary outcome [6] 300637 0
Parental mental health as measured by the three subscales of the Depression Anxiety Stress Scales-21 (DASS-21) self-report questionnaire.
Timepoint [6] 300637 0
Pre- intervention, post-intervention, and 6-month follow-up.
Secondary outcome [7] 300638 0
Inter-parental conflict over childrearing as measured by the Parent Problem Checklist (PPC) self-report questionnaire (two parent families only).
Timepoint [7] 300638 0
Pre-intervention, post-intervention, and 6-month follow-up.
Secondary outcome [8] 300639 0
Spousal relationship satisfaction as measured by the Relationship Quality Index (RQI) self-report questionnaire (two parent families only).
Timepoint [8] 300639 0
Pre-intervention, post-intervention, and 6-month follow-up.
Secondary outcome [9] 300640 0
Family demographic information measured by the Family Background Questionnaire (FBQ).
Timepoint [9] 300640 0
Pre-intervention.
Secondary outcome [10] 300641 0
Consumer satisfaction with the intervention as measured by the Discussion Group Satisfaction Questionnaire (DGSQ) and the Client Satisfaction Questionnaire (CSQ).
Timepoint [10] 300641 0
The Discussion Group Satisfaction Questionnaire is administered at the end of each group session. The Client Satisfaction Questionnaire is administered at post-intervention.
Secondary outcome [11] 300642 0
Treatment fidelity measured by the Triple P Discussion Group session checklists.
Timepoint [11] 300642 0
The checklists are completed by the Triple P practitioner at the end of each group session. All Triple P Discussion Groups will be videotaped and approximately 30% of the videotaped sessions will be randomly checked by an independent observer and treatment fidelity will be recorded using the same session checklist.

Eligibility
Key inclusion criteria
- Parent has a child between the ages of 5 and 8 years.

- Parent reports that the target child displays at least a mild level of behaviour problems (Measured using a 15-item version of the Eyberg Child Behavior Inventory, a score of 45 or more is needed).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- The target child has a developmental or intellectual disability or other significant health impairment (rationale: the Triple P Discussion Groups are designed for children with behavioural problems that are otherwise normally developing. A modified version of Triple P, Stepping Stones Triple P, has been specifically designed to meet the unique needs of parents who have children with a developmental, intellectual, or health disability).

- The target child is currently having regular contact with another mental health professional for behavioural problems (rationale: if the target child is currently receiving support from another service, then it will be difficult to disentangle potential benefits gained from the provided programme from those gained by this external support).

- The parent/s is currently seeing a mental health professional for emotional or psychological problems, or for their child's behavioural problems (rationale: if parents are receiving support from another service, then it will be difficult to disentangle potential benefits gained from the provided programme from those gained by this external support).

- The parent/s are not able to read a newspaper without assistance (rationale: the written materials and discussion-based format of this programme is not suitable for parents who cannot read a newspaper 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 self-refer to the researcher. Information about the study protocol is explained and a screening interview is conducted to determine participant eligibility. Written informed consent is collected and pre-intervention measures are then administered. Randomisation to condition is conducted at the level of individual children in sequence of completion of pre-intervention measures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated list of random is used to allocate to condition. Allocation is stratified to control for study site (West vs. Central Auckland) and household configuration (e.g., one- vs. two-parent families). Allocation to condition will be conducted by an individual independent of the study to ensure there is no bias in the allocation.
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

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
25/08/2011
Actual
25/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 4685 0
New Zealand
State/province [1] 4685 0
Auckland region

Funding & Sponsors
Funding source category [1] 286340 0
University
Name [1] 286340 0
Faculty of Education, University of Auckland
Country [1] 286340 0
New Zealand
Primary sponsor type
Individual
Name
Dr Louise Keown (Main Supervisor of Melanie Palmer)
Address
Faculty of Education, University of Auckland
Private Bag 92601, Symonds Street
Auckland 1150
Country
New Zealand
Secondary sponsor category [1] 285132 0
Individual
Name [1] 285132 0
Melanie Palmer (PhD student)
Address [1] 285132 0
Faculty of Education, University of Auckland
Private Bag 92601, Symonds Street
Auckland 1150
Country [1] 285132 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288417 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 288417 0
Ethics committee country [1] 288417 0
New Zealand
Date submitted for ethics approval [1] 288417 0
Approval date [1] 288417 0
29/07/2011
Ethics approval number [1] 288417 0
2011 / 360

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

Contacts
Principal investigator
Name 34965 0
Dr Dr Louise Keown (Main Supervisor of Melanie Palmer)
Address 34965 0
Faculty of Education, University of Auckland
Private Bag 92601, Symonds Street
Auckland 1150
Country 34965 0
New Zealand
Phone 34965 0
+64 9 623 8899 ext 86435
Fax 34965 0
Email 34965 0
[email protected]
Contact person for public queries
Name 18212 0
Melanie Palmer
Address 18212 0
Faculty of Education, University of Auckland
Private Bag 92601, Symonds Street
Auckland 1150
Country 18212 0
New Zealand
Phone 18212 0
+64 9 623 8899 ext 83042
Fax 18212 0
Email 18212 0
[email protected]
Contact person for scientific queries
Name 9140 0
Melanie Palmer
Address 9140 0
Faculty of Education, University of Auckland
Private Bag 92601, Symonds Street
Auckland 1150
Country 9140 0
New Zealand
Phone 9140 0
+64 9 623 8899 ext 83042
Fax 9140 0
Email 9140 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.