Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000437662
Ethics application status
Approved
Date submitted
17/04/2014
Date registered
29/04/2014
Date last updated
26/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a brief intervention for parents of children aged 3-10 years old who are experiencing sibling conflict
Scientific title
A 2-hour parenting discussion group on managing fighting and aggression versus care-as-usual for parents of children experiencing sibling conflict in order to decrease sibling conflict, increase sibling warmth and decrease parents' use of ineffective parenting practices
Secondary ID [1] 283852 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sibling Conflict 291755 0
Agonism 291756 0
Arguments 291757 0
Physical Aggression 291758 0
Condition category
Condition code
Mental Health 291194 291194 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of one, 2-hour parenting discussion group on Managing Fighting and Aggression, designed to target the direct and indirect pathways of parenting impact on sibling conflict outcomes (i.e., parenting practices, and parenting confidence and stress). The Managing Fighting and Aggression discussion group targets parents of children with sibling conflict and is designed to assist parents in preventing and managing their children’s conflict effectively. The discussion group aims to combine education about conflict management with parenting strategies that will empower parents to ensure their children are implementing prevention and management plans appropriately (using checklists, charts, and diary keeping to track children’s progress).

Participants will be asked to complete a series of online measures on entry to the trial, four to six weeks later and at a 6-month follow up.
Intervention code [1] 288531 0
Behaviour
Comparator / control treatment
Families in care-as-usual will also be assessed on entry to the trial, four to six weeks later and again at six months. During this time, families will continue to undertake whatever practices they were previously using in attempting to manage their children’s conflict. After the 6-month follow-up assessment, families will be offered participation in the intervention.
Control group
Active

Outcomes
Primary outcome [1] 291866 0
Primary Outcome 1: improve children's sibling relationships through decreased levels of conflict between siblings. Measured through the agonism subscale of the Parental Expectations and Perceptions of Children's Sibling Relationship Questionnaire (PEPC-SRQ) (Kramer & Baron, 1995) and the How do you Manage Children's Conflict Measure (Kramer & Washo, 1999).
Timepoint [1] 291866 0
Timepoint: Baseline, 4 to 6 weeks later, 6 months later
Primary outcome [2] 291867 0
Primary Outcome 2: improve children's sibling relationships through increased warmth in the sibling relationship. Measured through the warmth subscale of the PEPC-SRQ (Kramer & Baron, 1995).
Timepoint [2] 291867 0
Timepoint: Baseline, 4 to 6 weeks later, 6 months later
Primary outcome [3] 291868 0
Primary Outcome 3: decrease parents' use of ineffective parenting practices in managing the sibling relationship. Measured through subscales of the How do you Manage Children's Conflict Measure (Kramer & Washo, 1999).
Timepoint [3] 291868 0
Timepoint: Baseline, 4 to 6 weeks later, 6 months later
Secondary outcome [1] 307698 0
Secondary Outcome 1: lower levels of child behavioural and emotional problems. Measured through the Child Adjustment and Parent Efficacy Scale (CAPES) (Morawska, Sanders, Haslam, Filus & Fletcher, in press).
Timepoint [1] 307698 0
Timepoint: Baseline, 4 to 6 weeks later, 6 months later
Secondary outcome [2] 307699 0
Secondary Outcome 2: increase parents' use of positive strategies in managing their children's behaviour. Measured through the Parenting and Family Adjustment Scale (PAFAS) (Sanders, Morawska, Haslam, Filus & Fletcher, 2014).
Timepoint [2] 307699 0
Timepoint: Baseline, 4 to 6 weeks later, 6 months later
Secondary outcome [3] 307700 0
Secondary Outcome 3: increase parents' confidence in improving their children's behaviour. Measured through the Child Adjustment and Parent Efficacy Scale (CAPES) (Morawska, Sanders, Haslam, Filus & Fletcher, in press).
Timepoint [3] 307700 0
Timepoint: Basline, 4 to 6 weeks later, 6 months later

Eligibility
Key inclusion criteria
(i) presence in the family of at least two children in the 3-10 year old age range with no more than four years separating the two children; (ii) presence of parental concern about sibling conflict; and (iii) an elevated score on the agonism subscale of the PEPC-SRQ (Parental Expectations and Perceptions of Children's Sibling Relationship Questionnaire);
Minimum age
3 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) child has a developmental delay or intellectural disability including language and speech impairment; (ii) the parents are currently receiving psychological assistance for their children's behaviour or to deal with their children's behaviour; or (iii) the parents are unable to attend The University of Queensland's St Lucia Campus on four separate occasions for the purpose of participating in the intervention.

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)
Following eligibility screening and completion of the pre-assessment measures, randomisation to condition will occur. Participants will be randomly allocated to either the intervention condition or care-as-usual condition using a computer random number generator. Allocation concealment will involve contacting the holder of the allocation schedule who is “off-site” or at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a table created by computer software. Depending on recruitment rates, parents may be randomised in a block sequence (i.e., 15 parents randomised concurrently) The experimenter will be blind to the process of randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants in the Intervention condition receive the intervention after completing the pre-assessment measures. Participants in the care-as-usual condition will receive the intervention at the completion of the trial.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was conducted to determine the required sample size. To detect a medium effect size of .50, with alpha of .05, and power at .80, a minimum of 50 participants per cell is required (N = 100 for the two-group study).

ANOVA and MANOVA methods will be used to evaluate the data across the timepoints and between the conditions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/05/2014
Actual
2/06/2014
Date of last participant enrolment
Anticipated
Actual
28/07/2015
Date of last data collection
Anticipated
Actual
22/02/2016
Sample size
Target
100
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 289103 0
University
Name [1] 289103 0
The University of Queensland
Country [1] 289103 0
Australia
Primary sponsor type
Individual
Name
John Pickering
Address
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 287768 0
None
Name [1] 287768 0
Address [1] 287768 0
Country [1] 287768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290845 0
The University of Queensland Behavioural & Social Sciences Ethical Review Committee (BSSERC)
Ethics committee address [1] 290845 0
Ethics committee country [1] 290845 0
Australia
Date submitted for ethics approval [1] 290845 0
Approval date [1] 290845 0
17/12/2013
Ethics approval number [1] 290845 0

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

Contacts
Principal investigator
Name 45326 0
Mr John Pickering
Address 45326 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
AUSTRALIA
Country 45326 0
Australia
Phone 45326 0
+61 7 3346 8743
Fax 45326 0
Email 45326 0
[email protected]
Contact person for public queries
Name 45327 0
John Pickering
Address 45327 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
AUSTRALIA
Country 45327 0
Australia
Phone 45327 0
+61 7 3346 8743
Fax 45327 0
Email 45327 0
[email protected]
Contact person for scientific queries
Name 45328 0
John Pickering
Address 45328 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
AUSTRALIA
Country 45328 0
Australia
Phone 45328 0
+61 7 3346 8743
Fax 45328 0
Email 45328 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.