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Learning Effective Approaches to Prevention (CASALEAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00985595
Recruitment Status : Completed
First Posted : September 28, 2009
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
Aaron Hogue, The National Center on Addiction and Substance Abuse at Columbia University

Tracking Information
First Submitted Date September 25, 2009
First Posted Date September 28, 2009
Last Update Posted Date August 5, 2015
Study Start Date January 2006
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 25, 2009)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Learning Effective Approaches to Prevention
Official Title Quality Community Services for Adolescent Drug Abuse
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Adolescent Substance Abuse
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Mattos LA, Schmidt AT, Henderson CE, Hogue A. Therapeutic alliance and treatment outcome in the outpatient treatment of urban adolescents: The role of callous-unemotional traits. Psychotherapy (Chic). 2017 Jun;54(2):136-147. doi: 10.1037/pst0000093. Epub 2016 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 25, 2009)
200
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00985595
Other Study ID Numbers 165
1R01DA019607-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Aaron Hogue, The National Center on Addiction and Substance Abuse at Columbia University
Study Sponsor The National Center on Addiction and Substance Abuse at Columbia University
Collaborators Not Provided
Investigators
Principal Investigator: Aaron Hogue, Ph.D. The National Center on Addiction and Substance Abuse at Columbia University
PRS Account The National Center on Addiction and Substance Abuse at Columbia University
Verification Date August 2015