Disruptive Behavior DisorderABATENCT02488499
Addressing Behaviour and Treatment Effectiveness Project (A.B.A.T.E. Project)
A study testing Coping Power and Individualized Treatment in people with Disruptive Behavior Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Disruptive Behavior Disorder
- What is being tested?
- Coping Power and Individualized Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Evidence of Autism Spectrum Disorder or Asperger's Disorder as reported by parent, teacher or physician referral (if available).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Disruptive Behavior Disorder
- Being tested
- Coping Power, Individualized Treatment
- Keywords
- Disruptive Behaviour Disorder, Psychosocial, Group Treatment
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping PowerBehavioural
15 sessions of concurrent parent and child group treatment
Individualized TreatmentBehavioural
15 sessions of individualized child and parent treatment
| Study group | Role | What they receive |
|---|---|---|
| Individualized Treatment | Active comparator | 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. Receives: Behavioral: Individualized Treatment |
| Coping Power | Experimental | 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. Receives: Behavioral: Coping Power |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conduct Problems scale score measured by the Strengths and Difficulties Questionnaire
Measured: Change from Baseline Conduct Problems at 15-weeks and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJul 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Disruptive Behavior DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Responsible party
- Principal investigator, Brendan Andrade, Centre for Addiction and Mental Health
- Investigators
- Brendan F Andrade, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488499
- Sponsor's protocol ID
- 091/2010-03
- Acronym
- ABATE
- Status last verified
- Feb 2017
- First submitted
- 24 Jun 2015
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22642521Wells, K. C., Lochman, J. E., & Lenhart, L. A. (2008). Coping Power Parent Group Program: Facilitator Guide. New York: Oxford University Press.
Wells, K. C., Lochman, J. E., & Lenhart, L. A. (2008b). Coping Power: Facilitators Guide. New York: Oxford Press
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.
PubMed 15301641
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Behaviour and Treatment Effectiveness Project (A.B.A.T.E. Project)
- ClinicalTrials.gov ID
- NCT02488499
- Acronym / sponsor ID
- ABATE / 091/2010-03
- Conditions
- Disruptive Behavior Disorder
- Keywords
- Disruptive Behaviour Disorder, Psychosocial, Group Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Study start
- Jul 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Treatment | Active comparator | Behavioral: Individualized TreatmentIndividualized 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 | Experimental | Behavioral: Coping PowerCoping 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. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Evidence of Autism Spectrum Disorder or Asperger's Disorder as reported by parent, teacher or physician referral (if available).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping Power15 sessions of concurrent parent and child group treatment | Behavioural | Coping Power |
| Individualized Treatment15 sessions of individualized child and parent treatment | Behavioural | Individualized Treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Background: PubMed 22642521Lochman 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.
- BackgroundWells, K. C., Lochman, J. E., & Lenhart, L. A. (2008). Coping Power Parent Group Program: Facilitator Guide. New York: Oxford University Press.
- BackgroundWells, K. C., Lochman, J. E., & Lenhart, L. A. (2008b). Coping Power: Facilitators Guide. New York: Oxford Press
- Background: PubMed 15301641Lochman 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.
- CAMH ResearchLink provided by the sponsor.
Related trials for Disruptive Behavior Disorder
Not yet recruitingObservational study
Phase 1: Thrive Together: A Feasibility and Acceptability Evaluation of Peer Mentoring for High Schoolers With ADHD and Their Caregivers
Attention-Deficit/Hyperactivity Disorder (ADHD)
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
RecruitingPhase 3
A Long-term Trial of EB-1020 in Adult Patients With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan F Andrade, Ph.D. principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping Power and Individualized Treatment in people with Disruptive Behavior Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488499, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.