Individual and Group Intervention Formats With Aggressive Children
Primary Purpose
Aggressive Behavior
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individual intervention
Group Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Aggressive Behavior
Eligibility Criteria
Inclusion Criteria:
- top 25% in teacher-rated aggression and above low-aggressive range in parent-rated aggression
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Individual Intervention
Group Intervention
Arm Description
behavioral - children receive the Coping Power program in an individual, face-to-face format
behavioral - children receive the Coping Power program in a small group format (5-6 children per group)
Outcomes
Primary Outcome Measures
Behavior Assessment System for Children, Externalizing Behavior
Secondary Outcome Measures
Full Information
NCT ID
NCT01710969
First Posted
October 16, 2012
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01710969
Brief Title
Individual and Group Intervention Formats With Aggressive Children
Official Title
Individual and Group Intervention Formats With Aggressive Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Specific Aim 1: The study will test the hypothesis that the Coping Power intervention will produce larger effect sizes when delivered in an individual format in comparison to a group format. Although there are advantages of both formats, pilot data suggests that the group format may be diminishing the strength of outcome effects of intervention in comparison to the same intervention delivered in individual format. This pilot data is consistent with some prior findings, but a direct randomized comparison of children assigned to group versus individual formats has not been conducted, despite the critically important conceptual, clinical, and policy implications.
Hypothesis 1-1: It is hypothesized that ICP will produce greater reductions in behavior outcomes including substance use, externalizing behavior problems, and delinquency at a 1-year follow-up, in comparison to GCP.
Hypothesis 1-2: it is hypothesized that the ICP condition will produce greater improvements in children's social competence, which is directly targeted by the intervention, in comparison to GCP.
Specific Aim 2: Individual and group variation in effect sizes will be an outcome of youth behavior in the group (i.e., deviancy training) and group leader behavior management skill. We see youth behavior to be highly influenced by group leader management practices. We understand that some groups and/or individual children present challenges to even the most competent group leaders, and therefore, variation will be observable and meaningful. The design of the study allows for the testing of both group level and individual effects, and linkage of these effects to specific behaviors. Such information will provide an empirical basis for clinical training for group interventions with youth in general and Coping Power in particular.
Hypothesis 2-1: It is hypothesized that peer escalation in the GCP condition will predict worse outcomes, and that the level of group deviance in the GCP condition will moderate the effectiveness of the GCP condition, with better outcome effects for the groups with the highest initial screening scores.
Hypothesis 2-2: It is hypothesized that group interventions will be compromised by individual children's reactions to the interpersonal dynamics of the groups, such as inadvertent attention to deviant behavior and talk provided by group members and/or the group leader.
Hypothesis 2-3: It is hypothesized that level of positive group leader behaviors (directing attention to rules, correcting behavior, providing praise for compliance, introduction and review of activities, clear directions) will moderate the effectiveness of the GCP condition.
Specific Aim 3: Variability in outcome scores will differ between conditions. Hypothesis 3-1: It is hypothesized that there will be greater variability in the outcome scores of children in the GCP condition than in those of children in the ICP condition.
Specific Aim 4: Child characteristics will be examined as potential moderators of intervention effects.
Hypothesis 4-1: It is hypothesized that youth with low effortful control will be most vulnerable to deviancy effects in group interventions and therefore will show lower effect sizes than youth higher in effortful control at baseline. Thus we expect effortful control to function as a moderator of group intervention effectiveness, but not individual intervention effectiveness.
Research Question 1: In addition, we will investigate the possibility that characteristics of the youth's decision-making (impulsive decision-making; outcome expectations), affective arousal (callous-unemotional traits; low physiological arousal in response to negative consequences), temperament and behavior characteristics (baseline severity of aggressive behavior); perceived and actual peer reactions (perceived peer competence; peer rejection; peer victimization; deviant peers) and demographic characteristics (sex; age; race) will moderate the effectiveness of both interventions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individual Intervention
Arm Type
Experimental
Arm Description
behavioral - children receive the Coping Power program in an individual, face-to-face format
Arm Title
Group Intervention
Arm Type
Experimental
Arm Description
behavioral - children receive the Coping Power program in a small group format (5-6 children per group)
Intervention Type
Behavioral
Intervention Name(s)
Individual intervention
Intervention Description
34 weekly sessions of cognitive-behavioral Coping Power intervention, delivered in an individual one-to-one format
Intervention Type
Behavioral
Intervention Name(s)
Group Intervention
Intervention Description
34 weekly sessions of Coping Power intervention, delivered in a small group format (6 children per gorup)
Primary Outcome Measure Information:
Title
Behavior Assessment System for Children, Externalizing Behavior
Time Frame
Baseline, Mid-Intervention, Post-Intervention; 1 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
top 25% in teacher-rated aggression and above low-aggressive range in parent-rated aggression
Exclusion Criteria:
-
12. IPD Sharing Statement
Learn more about this trial
Individual and Group Intervention Formats With Aggressive Children
We'll reach out to this number within 24 hrs