NCT01710969

Brief Summary

The planned study will randomly assign aggressive children to one of two versions of the Coping Power child component. The two versions of Coping Power will either deliver the child component of the program in the usual small group format (Group Coping Power: GCP) or in a newly-developed individual format (Individual Coping Power: ICP). By providing a direct comparison of two different formats of the same intervention, the planned study's design will fill a critical gap in our current understanding of the relative effectiveness of group vs. individual programs. Further, this study will allow for examination of the specific factors that influence relative effectiveness of these two formats, important information with broad implications for program development, training of clinicians, and intervention implementation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 11, 2017

Status Verified

April 1, 2015

Enrollment Period

5.8 years

First QC Date

October 16, 2012

Last Update Submit

January 10, 2017

Conditions

Aggressive Behavior

Outcome Measures

Primary Outcomes (1)

  • Behavior Assessment System for Children, Externalizing Behavior

    Baseline, Mid-Intervention, Post-Intervention; 1 year follow-up

Study Arms (2)

Individual Intervention

EXPERIMENTAL

behavioral - children receive the Coping Power program in an individual, face-to-face format

Behavioral: Individual intervention

Group Intervention

EXPERIMENTAL

behavioral - children receive the Coping Power program in a small group format (5-6 children per group)

Behavioral: Group Intervention

Interventions

Individual interventionBEHAVIORAL

34 weekly sessions of cognitive-behavioral Coping Power intervention, delivered in an individual one-to-one format

Individual Intervention
Group InterventionBEHAVIORAL

34 weekly sessions of Coping Power intervention, delivered in a small group format (6 children per gorup)

Group Intervention

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • top 25% in teacher-rated aggression and above low-aggressive range in parent-rated aggression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Doddridge Saxon Chairholder in Clinical Psychology

Study Record Dates

First Submitted

October 16, 2012

First Posted

October 19, 2012

Study Start

September 1, 2008

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

January 11, 2017

Record last verified: 2015-04