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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00561041
Other study ID # NIAAA_KAM_012187
Secondary ID NIH grant number
Status Completed
Phase Phase 2
First received November 19, 2007
Last updated November 19, 2007
Start date November 2005
Est. completion date November 2006

Study information

Verified date November 2007
Source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The study examines the relative efficacy of two active aftercare interventions (i.e., face-to-face , brief phone) with no-active aftercare for adolescents who completed outpatient treatment for alcohol use disorders(AUD)


Description:

In this study 177 adolescents meeting criteria for alcohol use disorders (AUD) received weekly cognitive-behavioral therapy group sessions. 144 completers were randomized into the 3 individual aftercare (AR) conditions noted above. Manualized active interventions were composed of 5 sessions of integrated motivational enhancement and cognitive behavioral therapies. Outcomes assessments were done at end of aftercare, 3-6-and 12 months post AC completion.


Recruitment information / eligibility

Status Completed
Enrollment 177
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria:

- Adolescents between the ages of 13-18 years

- Meeting criteria for DSM-IV alcohol use disorders

- Able to comprehend and read English at the 5th grade level

- Participant and family member are willing to provide a locator information.

- Not planning to move out of state during the next 12 months

Exclusion Criteria:

- Meet any substance dependence criteria other than nicotine or cannabis

- Meet life time diagnosis of schizophrenia

- Reported a suicidal ideation with a plan, suicidal attempt, or self-injurious behavior in the last 30 days

- Having a medical condition that may prevent them from consistently attending and constructively participating in treatment and aftercare

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief phone aftercare intervention
Interventions is composed of 5 integrated cognitive-behavioral and motivational enhancement therapies administered during a period of 3 months according to a similar schedule
individual aftercare therapy
composed of 5 integrated cognitive-behavioral and motivational enhancement Therapies administered during a period of 3 months according to a similar schedule

Locations

Country Name City State
United States University of Connecticut Health Center Farmington Connecticut

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol use (days of use and days of heavy drinking) 3, 6, and 12 months post aftercare condition completion
Secondary Drug use according to primary outcome timeframe 3, 6, and 12 months post aftercare condition completion
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