- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03004781
Stimulation of Parents' Self-efficacy Beliefs and Emotion Coaching Practices (H2M1) (H2M1)
December 23, 2016 updated by: Isabelle Roskam, Université Catholique de Louvain
Stimulation of Parents' Self-efficacy Beliefs and Emotion Coaching Practices to Reduce Externalizing Behavior in Preschoolers
This research compared the efficacy of two parenting interventions that vary according to the number and the nature of variables in reducing preschoolers' externalizing behavior (EB).
The goal was to identify which parenting intervention format (one-variable versus two-variable) caused higher behavioral adjustment in children.
Study Overview
Detailed Description
The first format was a one-variable intervention manipulating parental self-efficacy beliefs.
The second format was a two-variable intervention manipulating both parents' self-efficacy beliefs and emotion coaching practices.
The two interventions shared exactly the same design, consisting of eight parent group sessions.
Effect on children's EB and observed behaviors were evaluated through a multi-method assessment at three points (pre-test, post-test and follow-up).
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children in the clinical or borderline range of the EB scale (cut-off = 21 or higher) of the Child Behavior Checklist preschool form (Achenbach & Rescorla, 2000a)
- three to six years old and still in kindergarten at the beginning of the intervention
Exclusion Criteria:
- children with intellectual disabilities (average IQ < 5.5)
- highly gifted children (average IQ >14.5)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waiting-list
8-week period without intervention, N=45
|
|
|
Experimental: self-efficacy
8-week group-based parenting program on self-efficacy beliefs, N=19
|
|
|
Experimental: self-efficacy/emotion coaching
8-week group-based parenting program on self-efficacy beliefs and emotion coaching practice, N=26
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in child behavior
Time Frame: 0 week, 8 weeks, 24 weeks
|
parent reports of child behavior and standardized observation of parent-child interaction
|
0 week, 8 weeks, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in parental self-efficacy beliefs
Time Frame: 0 week, 8 weeks, 24 weeks
|
parent questionnaire
|
0 week, 8 weeks, 24 weeks
|
|
Change in parenting behavior
Time Frame: 0 week, 8 weeks, 24 weeks
|
standardized observation of parent-child interaction
|
0 week, 8 weeks, 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
December 20, 2016
First Submitted That Met QC Criteria
December 23, 2016
First Posted (Estimate)
December 29, 2016
Study Record Updates
Last Update Posted (Estimate)
December 29, 2016
Last Update Submitted That Met QC Criteria
December 23, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCLouvain_H2M1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.