Learning Effective Approaches to Prevention (CASALEAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by The National Center on Addiction and Substance Abuse at Columbia University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The National Center on Addiction and Substance Abuse at Columbia University
ClinicalTrials.gov Identifier:
NCT00985595
First received: September 25, 2009
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

The objective of the study is to test the effectiveness, implementation quality, and cost effectiveness of family-based treatment services for adolescent substance abuse delivered in an agency setting.


Condition
Adolescent Substance Abuse

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Quality Community Services for Adolescent Drug Abuse

Further study details as provided by The National Center on Addiction and Substance Abuse at Columbia University:

Primary Outcome Measures:
  • The primary aims of the study are to examine the effectiveness of FBEI versus SAU and to compare the strength of FBEI adherence and outcomes to performance benchmarks set during a previous FBEI efficacy trial. [ Time Frame: 3, 6, 12 months after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary aims are to compare cost effectiveness, services utilization, and consumer satisfaction in FBEI versus SAU. [ Time Frame: 3, 6, 12 months after baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: January 2006
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Despite the success of family-based ecological interventions (FBEI) in controlled trials, this highly promising services approach has not been tested under pure field conditions with ASA populations. Controlled effectiveness research invariably enhances training, supervision, and service delivery conditions in partnering sites in an effort to ensure treatment adherence and consistency. An alternative strategy for advancing dissemination science is rigorous naturalistic research on community clinics that already implement evidence-based practices in the course of routine care. The proposed study will follow this "bottom up" strategy by investigating the quality and impact of ASA services delivered by front-line therapists in a community-based mental health center that already features FBEI as the routine standard of care. The study will use a randomized design to compare naturalistic FBEI services to services as usual (SAU) for ASA. Participants (N = 260) will be recruited from local high schools, enrichment programs, and juvenile justice programs. Eligible adolescents will meet ASAM criteria for outpatient treatment. The SAU condition will contain the three most common service venues for ASA in urban communities: hospital-based ambulatory mental health clinics, drug counseling/addictions specialty clinics, and community mental health centers. The primary aims of the study are to examine the effectiveness of FBEI versus SAU and to compare the strength of FBEI adherence and outcomes to performance benchmarks set during a previous FBEI Stage II efficacy trial. The secondary aims are to compare cost effectiveness, services utilization, and consumer satisfaction in FBEI versus SAU. A multitrait, multimethod assessment design will include adolescent and parent interviews at baseline and 3, 6, and 12 months follow-up. Cost and service utilization data will be collected from self report and from provider agencies in both conditions. The study will yield the first evidence on whether a widely endorsed treatment approach for ASA is potent and feasible in real-world conditions and superior to SAU in outcomes and cost-benefit. An important secondary yield will be increasing the scarce knowledge base on commonly practiced community approaches in the SAU condition.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adolescents screened for symptoms of substance abuse/dependence, and their families, will participate in the study. Participants will include 260 male and female adolescents who complete the enrollment process, meet eligibility criteria, and consent to be randomized into one of two study conditions. Youth will be referred primarily from two sources: juvenile justice agencies and local schools/community programs. Based on the demographics of adolescents currently participating in partner sites, youth are likely to be predominantly male (69%), Hispanic (68%), and African American (32%). Families are generally low income from disadvantaged neighborhoods, with high rates of family mental health and substance use problems.

Criteria

Inclusion Criteria:

  1. ages 13 and 17,
  2. have a caregiver willing to participate in treatment,
  3. meet ASAM criteria for outpatient or intensive outpatient substance abuse treatment,
  4. not receiving any other behavioral treatment, and
  5. have public or private health benefits that meet standard community clinic registration requirements.

Exclusion Criteria:

  1. mental retardation,
  2. pervasive developmental disorder,
  3. medical or psychiatric illness requiring hospitalization,
  4. current psychotic features, or
  5. current suicidality (Ideation + Plan + High Intention).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985595

Contacts
Contact: Aaron Hogue, Ph.D. 212-841-5278 ahogue@aol.com
Contact: Jon Morgenstern, Ph.D. 212-841-5247 jmorgenstern@casacolumbia.org

Locations
United States, New York
The National Center on Addiction and Substance Abuse at Columbia University Recruiting
New York, New York, United States, 10017
Contact: Aaron Hogue, Ph.D.    212-841-5278    ahogue@aol.com   
The National Center on Addiction and Substance Abuse at Columbia University Recruiting
New York, New York, United States, 10017
Sponsors and Collaborators
The National Center on Addiction and Substance Abuse at Columbia University
Investigators
Principal Investigator: Aaron Hogue, Ph.D. The National Center on Addiction and Substance Abuse at Columbia University
  More Information

No publications provided

Responsible Party: Aaron Hogue, Ph.D./Associate Director of Health and Treatment Research and Analysis, The National Center on Addiction and Substance Abuse at Columbia University
ClinicalTrials.gov Identifier: NCT00985595     History of Changes
Other Study ID Numbers: 165, 1 R01 DA019607-01
Study First Received: September 25, 2009
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The National Center on Addiction and Substance Abuse at Columbia University:
Adolescent
substance abuse

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014