NCT01667159

Brief Summary

This study will examine the effectiveness of an integrated treatment for adolescents who are depressed and use alcohol in an intensive outpatient setting in the community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P75+ for phase_1 depression

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_1 depression

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

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

4.7 years

First QC Date

August 14, 2012

Last Update Submit

January 21, 2018

Conditions

DepressionAlcohol Use

Keywords

DepressionAlcohol UseOutpatient Therapy

Outcome Measures

Primary Outcomes (1)

  • Depression

    Measured at 18 months from baseline

Secondary Outcomes (1)

  • Alcohol/Substance Use

    Measured at 18 months from baseline

Study Arms (2)

Integrated Cognitive Behavioral Therapy

EXPERIMENTAL

Adolescents and their parent(s) will receive integrated cognitive behavioral therapy.

Behavioral: Integrated Cognitive Behavioral Therapy

Standard Care

ACTIVE COMPARATOR

Adolescents and their parent(s) will receive treatment as usual through a community intensive outpatient program.

Behavioral: Standard Care

Interventions

Integrated Cognitive Behavioral TherapyBEHAVIORAL

Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions delivered at least 1-2x each week for 6 months.

Also known as: CBT for adolescents and parents
Integrated Cognitive Behavioral Therapy
Standard CareBEHAVIORAL

Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.

Also known as: Intensive Outpatient Therapy, Treatment As Usual (TAU)
Standard Care

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • English speaking adolescent and parent
  • Current substance use disorder
  • Co-occurring psychiatric symptomatology

You may not qualify if:

  • IQ \< 80
  • Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa
  • Adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (2)

  • Spirito A, Nestor B, Massing-Schaffer M, Esposito-Smythers C, Stout R, Frazier E, Gomez J, Graves H, Yen S, Hunt J, Wolff J. Predictors and moderators of marijuana and heavy alcohol use outcomes in adolescents treated for co-occurring substance use and psychiatric disorders in a randomized controlled trial. J Subst Abuse Treat. 2021 Dec;131:108536. doi: 10.1016/j.jsat.2021.108536. Epub 2021 Jun 15.

    PMID: 34238628DERIVED

  • MacPherson HA, Wolff J, Nestor B, Frazier E, Massing-Schaffer M, Graves H, Esposito-Smythers C, Spirito A. Parental Monitoring Predicts Depressive Symptom and Suicidal Ideation Outcomes in Adolescents Being Treated for Co-Occurring Substance Use and Psychiatric Disorders. J Affect Disord. 2021 Apr 1;284:190-198. doi: 10.1016/j.jad.2021.02.021. Epub 2021 Feb 9.

    PMID: 33607509DERIVED

MeSH Terms

Conditions

DepressionAlcohol Drinking

Interventions

Standard of CareTherapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDrinking Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Anthony Spirito, Ph.D.

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 17, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2017

Study Completion

December 1, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)