NCT03004781

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

5 months

First QC Date

December 20, 2016

Last Update Submit

December 23, 2016

Conditions

Keywords

parenting interventionexternalizing behavioremotion coaching practicesself-efficacy beliefs

Outcome Measures

Primary Outcomes (1)

  • Change in child behavior

    parent reports of child behavior and standardized observation of parent-child interaction

    0 week, 8 weeks, 24 weeks

Secondary Outcomes (2)

  • Change in parental self-efficacy beliefs

    0 week, 8 weeks, 24 weeks

  • Change in parenting behavior

    0 week, 8 weeks, 24 weeks

Study Arms (3)

Waiting-list

NO INTERVENTION

8-week period without intervention, N=45

self-efficacy

EXPERIMENTAL

8-week group-based parenting program on self-efficacy beliefs, N=19

Behavioral: Parenting program

self-efficacy/emotion coaching

EXPERIMENTAL

8-week group-based parenting program on self-efficacy beliefs and emotion coaching practice, N=26

Behavioral: Parenting program

Interventions

self-efficacyself-efficacy/emotion coaching

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • children with intellectual disabilities (average IQ \< 5.5)
  • highly gifted children (average IQ \>14.5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 29, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

December 29, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share