NCT01656707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

4.8 years

First QC Date

August 1, 2012

Last Update Submit

April 10, 2017

Conditions

Mental DisordersAddictive BehaviorsCannabis Use Disorder

Keywords

AdolescentsSubstance Use Disorders

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (1)

  • 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.

    one year

Study Arms (2)

ACRA

EXPERIMENTAL

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

Behavioral: ACRA

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

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

Behavioral: CBT

Interventions

ACRABEHAVIORAL

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

Also known as: Adolescent Community Reinforcement Approach
ACRA
CBTBEHAVIORAL

10 weekly, 60-minute sessions of augmented individualized CBT

Also known as: Cogntive Behavioral Therapy
Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030-2103, United States

Location

MeSH Terms

Conditions

Mental DisordersBehavior, AddictiveSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorChemically-Induced Disorders

Study Officials

  • Yifrah Kaminer, MD, MBA

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2012

First Posted

August 3, 2012

Study Start

September 1, 2011

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

US(1)