Ignite Creation Date:
2024-05-06 @ 1:02 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01710969
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2012-10-16
Brief Title:
Individual and Group Intervention Formats With Aggressive Children
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Individual and Group Intervention Formats With Aggressive Children
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studys 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 childrens 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 ie 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 andor 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 childrens reactions to the interpersonal dynamics of the groups such as inadvertent attention to deviant behavior and talk provided by group members andor 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 youths 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
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 childrens 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 ie 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 andor 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 childrens reactions to the interpersonal dynamics of the groups such as inadvertent attention to deviant behavior and talk provided by group members andor 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 youths 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA023156 | NIH | None | httpsreporternihgovquickSearchR01DA023156 |