Relapse Prevention for Suicidal Dually Diagnosed Youths

NCT00589641 | Completed Phase 1 DMC

• 3 other identifiers: Pro00006806R34MH067904303-7105
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop, refine, and pilot test an augmenting cognitive behavior relapse prevention intervention (CBT-RP) for suicidal, depressed, and alcohol/substance abusing adolescents. No hypotheses are being tested, but it is expected that CBT-RP in addition to treatment as usual will result in improved outcomes relative to treatment as usual alone.

Conditions

Suicide, Attempted; Suicide, Ideation; Depression; Substance Abuse

Keywords

adolescents; suicidal ideation and behavior; depression; substance abuse

Outcome Measures

Primary Outcomes (1)

• suicide ideation and behavior

  pre-treatment, 10 weeks, end of treatment, 3-month follow-up

Secondary Outcomes (1)

• depression severity, alcohol/cannabis abuse impairment

  pre-treatment, 10 weeks, end of treatment, 3 month follow-up

Study Arms (2)

CBT-RP + Enhanced TAU

EXPERIMENTAL

CBT-RP augmenting relapse prevention intervention, in addition to enhanced treatment as usual, monthly check-ins, and monitoring

Behavioral: CBT-RP (relapse prevention) + Enhanced TAU

Enhanced TAU (Treatment as Usual)

ACTIVE COMPARATOR

Treatment as usual in the community, monthly monitoring regarding service use and needs, monitoring

Behavioral: Enhanced TAU Alone

Interventions

CBT-RP (relapse prevention) + Enhanced TAU BEHAVIORAL

CBT-RP is an 20-week augmenting intervention. CBT-RP is based primarily on Alan Marlatt's cognitive behavioral relapse prevention model for substance abuse, but also includes motivational interviewing and mindfulness meditation approaches. Sessions are twice a week in first week, then weekly thereafter, with tapering to biweekly in the last 8 weeks depending on improvement. Participants also receive treatment as usual, and monthly check-ins regarding treatment use.

CBT-RP + Enhanced TAU

Enhanced TAU Alone BEHAVIORAL

Treatment as usual in the community, monthly check-ins regarding treatment use or needs, and monitoring

Enhanced TAU (Treatment as Usual)

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Teenagers 13-19 living with parents, or foster parents, at least one of whom is English speaking and willing to participate
• Participation in ongoing treatment in the community (or willing to accept a referral for treatment as usually delivered in the community)
• Marijuana or alcohol use or dependence disorder
• Depressive disorder (major depression, dysthymia, depressive disorder NOS)
• High suicide risk as reflected in: (a) recent suicidal behaviors (suicide attempts, aborted attempts, interrupted attempts, or suicide plans) in last 4 weeks OR (b)lifetime history of suicidal behaviors together with current clinically significant suicidal ideation (measured on a self-report questionnaire)

You may not qualify if:

• Substance Dependence Disorder other than alcohol or cannabis or nicotine
• SUD severity such that higher (more intensive) level of treatment (e.g., residential, hospitalization) is needed
• Psychiatric difficulty other than substance abuse, suicidality, or depression that needs to be the primary focus of treatment (e.g., severe eating disorder or psychosis)
• Evidence of mental retardation or poor receptive vocabulary as assessed with Peabody Picture Vocabulary Test

Sponsors & Collaborators

• Duke University: lead
• UConn Health: collaborator
• University of North Carolina, Chapel Hill: collaborator
• University of North Carolina, Greensboro: collaborator

Study Sites (1)

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Suicide, Attempted; Suicide; Depression; Substance-Related Disorders; Suicidal Ideation; Behavior

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• David B Goldston, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: January 10, 2008
• Study Start: July 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 10, 2014

Record last verified: 2010-06

Locations

US (1)