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Individual and Group Intervention Formats With Aggressive Children

10. januar 2017 opdateret af: National Institute on Drug Abuse (NIDA)
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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

360

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

9 år til 12 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

-

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Individual Intervention
behavioral - children receive the Coping Power program in an individual, face-to-face format
34 weekly sessions of cognitive-behavioral Coping Power intervention, delivered in an individual one-to-one format
Eksperimentel: Group Intervention
behavioral - children receive the Coping Power program in a small group format (5-6 children per group)
34 weekly sessions of Coping Power intervention, delivered in a small group format (6 children per gorup)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Behavior Assessment System for Children, Externalizing Behavior
Tidsramme: Baseline, Mid-Intervention, Post-Intervention; 1 year follow-up
Baseline, Mid-Intervention, Post-Intervention; 1 year follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2008

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først indsendt

16. oktober 2012

Først indsendt, der opfyldte QC-kriterier

17. oktober 2012

Først opslået (Skøn)

19. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. januar 2017

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DESPR DA023156
  • R01DA023156 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Aggressiv adfærd

Kliniske forsøg med Individual intervention

Abonner