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Addressing Behaviour and Treatment Effectiveness Project (A.B.A.T.E. Project) (ABATE)

Primary Purpose

Disruptive Behavior Disorder

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Coping Power

Individualized Treatment

About this trial

This is an interventional treatment trial for Disruptive Behavior Disorder focused on measuring Disruptive Behaviour Disorder, Psychosocial, Group Treatment

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Parents provide free and informed consent and children assent to participate in the research, complete measures, and participate in either Coping Power or individualized treatment.
Parents report symptoms consistent with clinical diagnoses of Oppositional Defiant Disorder or Conduct Disorder on the Diagnostic Interview Schedule for Children - DSM IV or parents and/or teacher report at or above a T-score of 60 (93rd percentile; borderline clinically severe range) on the Externalizing Behavior composite scale on the Behavior Assessment for Children - 2nd edition.
Parents or teachers report clinically severe impairment in social, family, peer or overall functioning demonstrated by scores in the clinical range on the parent or teacher completed Impairment Rating Scale.
The child's cognitive functioning is at or above a standard score of 80 (Borderline Range) on the verbal and/or nonverbal scales on the Kaufman Brief Intelligence Task - 2.

Exclusion Criteria:

Evidence of Autism Spectrum Disorder or Asperger's Disorder as reported by parent, teacher or physician referral (if available).

Sites / Locations

Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Individualized Treatment

Coping Power

Arm Description

Individualized Treatment: 15 sessions of individualized treatment (i.e., parent-child) that target areas of presenting concern identified during assessment. These may include social problem-solving, emotion regulation, parent-child difficulties.

Coping Power: 15 sessions of concurrent parent and child group treatment. The child group focuses on developing problem-solving and emotion regulation skills. The parent group focuses on developing parenting skills and problem-solving strategies to manage and reduce their children's disruptive behaviour.

Outcomes

Primary Outcome Measures

Conduct Problems scale score measured by the Strengths and Difficulties Questionnaire

Secondary Outcome Measures

Full Information

NCT ID

NCT02488499

First Posted

June 24, 2015

Last Updated

February 6, 2017

Sponsor

Centre for Addiction and Mental Health

Collaborators

Ontario Mental Health Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02488499

Brief Title

Addressing Behaviour and Treatment Effectiveness Project (A.B.A.T.E. Project)

Acronym

ABATE

Official Title

Addressing Behaviour and Treatment Effectiveness Project (A.B.A.T.E. Project)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre for Addiction and Mental Health

Collaborators

Ontario Mental Health Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study investigates the effectiveness of a clinic-adapted version of the Coping Power program compared to individualized child and family treatment for children with disruptive behaviour and their parents.

Detailed Description

This project compares the short- and long-term effectiveness of a clinic-adapted manualized group treatment (i.e., Coping Power; CP) to individualized child and family treatment for children aged 9 - 12 with disruptive behaviour. Children and their parents who meet criteria and agree to participate in the project are randomly assigned to either the CP condition or the Individualized treatment condition. In the CP condition, children and caregivers are asked to participate in two separate but complimentary 15-session groups. Child groups target development of children's emotional and cognitive problem solving skills and caregiver groups facilitate cognitive and behavioural parenting skills. In the Individualized treatment condition children and caregivers are asked to participate in 15 one-hour individual and family treatment sessions tailored by the clinician to address the children and parent's presenting concerns. Measurement of behaviour and emotional functioning is done pre- post- and at 6-months following treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Disruptive Behavior Disorder

Keywords

Disruptive Behaviour Disorder, Psychosocial, Group Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

172 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Individualized Treatment

Arm Type

Active Comparator

Arm Description

Arm Title

Coping Power

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Coping Power

Intervention Description

15 sessions of concurrent parent and child group treatment

Intervention Type

Behavioral

Intervention Name(s)

Individualized Treatment

Intervention Description

15 sessions of individualized child and parent treatment

Primary Outcome Measure Information:

Title

Conduct Problems scale score measured by the Strengths and Difficulties Questionnaire

Time Frame

Change from Baseline Conduct Problems at 15-weeks and at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Parents provide free and informed consent and children assent to participate in the research, complete measures, and participate in either Coping Power or individualized treatment. Parents report symptoms consistent with clinical diagnoses of Oppositional Defiant Disorder or Conduct Disorder on the Diagnostic Interview Schedule for Children - DSM IV or parents and/or teacher report at or above a T-score of 60 (93rd percentile; borderline clinically severe range) on the Externalizing Behavior composite scale on the Behavior Assessment for Children - 2nd edition. Parents or teachers report clinically severe impairment in social, family, peer or overall functioning demonstrated by scores in the clinical range on the parent or teacher completed Impairment Rating Scale. The child's cognitive functioning is at or above a standard score of 80 (Borderline Range) on the verbal and/or nonverbal scales on the Kaufman Brief Intelligence Task - 2. Exclusion Criteria: Evidence of Autism Spectrum Disorder or Asperger's Disorder as reported by parent, teacher or physician referral (if available).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brendan F Andrade, Ph.D.

Organizational Affiliation

Centre for Addiction and Mental Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Addiction and Mental Health

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6J 1H4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

22642521

Citation

Lochman JE, Powell N, Boxmeyer C, Andrade B, Stromeyer SL, Jimenez-Camargo LA. Adaptations to the coping power program's structure, delivery settings, and clinician training. Psychotherapy (Chic). 2012 Jun;49(2):135-42. doi: 10.1037/a0027165.

Results Reference

background

Citation

Wells, K. C., Lochman, J. E., & Lenhart, L. A. (2008). Coping Power Parent Group Program: Facilitator Guide. New York: Oxford University Press.

Results Reference

background

Citation

Wells, K. C., Lochman, J. E., & Lenhart, L. A. (2008b). Coping Power: Facilitators Guide. New York: Oxford Press

Results Reference

background

PubMed Identifier

15301641

Citation

Lochman JE, Wells KC. The coping power program for preadolescent aggressive boys and their parents: outcome effects at the 1-year follow-up. J Consult Clin Psychol. 2004 Aug;72(4):571-8. doi: 10.1037/0022-006X.72.4.571.

Results Reference

background

Links:

URL

http://www.camh.net/research

Description

CAMH Research

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Addressing Behaviour and Treatment Effectiveness Project (A.B.A.T.E. Project)

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