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Adaptive Treatment for Adolescent Cannabis Use Disorders

Primary Purpose

Mental Disorders, Addictive Behaviors, Cannabis Use Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ACRA

CBT

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring Adolescents, Substance Use Disorders

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

13-18 years of age at the time of intake assessment
Current diagnosis of DSM-IV Cannabis Abuse or Dependence
Able to read and comprehend English at a 5th grade level
Residence within 45 minutes drive from the UCHC Farmington treatment site
Participant and a parent/legal guardian responsible for providing collateral information agree to sign an IRB approved consent form
Participant and a parent/legal guardian responsible for providing collateral information agree to provide locator information
The family is not planning to move from the area during the next six months

Exclusion Criteria:

Meet criteria for dependence of any other substance of abuse other than nicotine or alcohol
Report suicidal ideation with a plan, suicidal behavior, a plan to hurt oneself or other, or a history of self-injurious behavior all occurring in the last 30 days
Meet a lifetime diagnosis of schizophrenia
Has any current health (i.e. medical, psychiatric) condition that will compromise the participant's ability to regularly attend treatment
Demonstrate an inability or unwillingness to provide locator information

Sites / Locations

University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ACRA

Cognitive Behavioral Therapy (CBT)

Arm Description

Ten weekly 60-minute sessions of Adolescent Community Reinforcement Approach (ACRA) will be provided as an Adaptive treatment condition.

Ten weekly, 60-minute sessions of augmented individualized Cognitive Behavioral Therapy (CBT)will be provided as an Adaptive Treatment condition

Outcomes

Primary Outcome Measures

1.) To evaluate the efficacy of AT for youth who have been defined as poor responders to an evidence-based practice intervention such as the initial MET/CBT-7.

Each participant will serve as his/her own control. The outcomes will include the T-ASI, T-ASI-P, and drug urinalyses.

Secondary Outcome Measures

To assess outcomes as a function of mediator variables such as self-efficacy, coping skills, readiness to change, and environmental support (i.e., family and peer), within each of the AT interventions.

The secondary outcome measures will include the SCQ, CRI, PRQ, and SSQ.

Full Information

NCT ID

NCT01656707

First Posted

August 1, 2012

Last Updated

April 10, 2017

Sponsor

UConn Health

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT01656707

Brief Title

Adaptive Treatment for Adolescent Cannabis Use Disorders

Official Title

Adaptive Treatment for Adolescent Cannabis Use Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UConn Health

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to examine an Adaptive Treatment approach in order to improve outcomes of youth with Cannabis Use Disorders who are poor responders to treatment.

Detailed Description

The study will address the current contrasts in youth response to treatment, the problem of poor response to treatment and the prevention of relapse. Results from the study may support Adaptive Treatment as an efficacious approach for youth with Cannabis Use Disorder who are poor responders to treatment. Poor responders fall into two categories, those who failed to achieve a negative drug urinalysis during the last session of the initial MET/CBT-7 treatment they attended, and those who either dropped out or were administratively discharged at any time during the initial MET/CBT-7 treatment.

6. Conditions and Keywords

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

Mental Disorders, Addictive Behaviors, Cannabis Use Disorder

Keywords

Adolescents, Substance Use Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

172 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACRA

Arm Type

Experimental

Arm Description

Ten weekly 60-minute sessions of Adolescent Community Reinforcement Approach (ACRA) will be provided as an Adaptive treatment condition.

Arm Title

Cognitive Behavioral Therapy (CBT)

Arm Type

Experimental

Arm Description

Ten weekly, 60-minute sessions of augmented individualized Cognitive Behavioral Therapy (CBT)will be provided as an Adaptive Treatment condition

Intervention Type

Behavioral

Intervention Name(s)

ACRA

Other Intervention Name(s)

Adolescent Community Reinforcement Approach

Intervention Description

Ten weekly,60-minute therapy sessions including six individual, two parent/guardian and two joint (individual and parent/guardian).

Intervention Type

Behavioral

Intervention Name(s)

CBT

Other Intervention Name(s)

Cogntive Behavioral Therapy

Intervention Description

10 weekly, 60-minute sessions of augmented individualized CBT

Primary Outcome Measure Information:

Title

1.) To evaluate the efficacy of AT for youth who have been defined as poor responders to an evidence-based practice intervention such as the initial MET/CBT-7.

Description

Each participant will serve as his/her own control. The outcomes will include the T-ASI, T-ASI-P, and drug urinalyses.

Time Frame

one year

Secondary Outcome Measure Information:

Title

Description

The secondary outcome measures will include the SCQ, CRI, PRQ, and SSQ.

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 13-18 years of age at the time of intake assessment Current diagnosis of DSM-IV Cannabis Abuse or Dependence Able to read and comprehend English at a 5th grade level Residence within 45 minutes drive from the UCHC Farmington treatment site Participant and a parent/legal guardian responsible for providing collateral information agree to sign an IRB approved consent form Participant and a parent/legal guardian responsible for providing collateral information agree to provide locator information The family is not planning to move from the area during the next six months Exclusion Criteria: Meet criteria for dependence of any other substance of abuse other than nicotine or alcohol Report suicidal ideation with a plan, suicidal behavior, a plan to hurt oneself or other, or a history of self-injurious behavior all occurring in the last 30 days Meet a lifetime diagnosis of schizophrenia Has any current health (i.e. medical, psychiatric) condition that will compromise the participant's ability to regularly attend treatment Demonstrate an inability or unwillingness to provide locator information

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yifrah Kaminer, MD, MBA

Organizational Affiliation

UConn Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Connecticut Health Center

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030-2103

Country

United States

12. IPD Sharing Statement

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Adaptive Treatment for Adolescent Cannabis Use Disorders

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