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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00957775
Other study ID # R01DA025072
Secondary ID R01DA025072
Status Not yet recruiting
Phase N/A
First received August 11, 2009
Last updated August 11, 2009
Start date August 2009
Est. completion date July 2011

Study information

Verified date August 2009
Source National Development and Research Institutes, Inc.
Contact Michelle Acosta, Ph.D.
Phone 212-845-4535
Email acosta@ndri.org
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders.


Description:

Substance use among youth remains a major public health problem. About half of all 12th graders have tried an illicit drug and over 72% of this same age group have used alcohol. Rates of abuse of prescription opioids among youth are estimated to have increased about 542% in the past decade. Although effective substance abuse treatment programs for youth exist, they are currently of limited reach. Only 1 in 10 adolescents who need substance abuse treatment receive any care. An interactive, computer-delivered psychosocial (skills-training) intervention has the potential to address these challenges, as it allows for complex interventions to be delivered at a low cost, without increasing demands on staff time or training needs. It may also be highly acceptable to youth and enable widespread dissemination of science-based treatment in a manner that ensures fidelity.

In this project, we plan to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders. The content of this program will be based in a model of psychosocial substance abuse treatment for youth that has been shown to be effective in prior scientific research. It will be provided via an interactive, delivery system that employs informational technologies that are effective in promoting relevant knowledge and skills. Adolescents in substance abuse treatment will help shape the development of this program. To our knowledge, the planned program will be the first interactive program to provide comprehensive, psychosocial substance abuse treatment to adolescents via computer-based technology.

This research will contribute new information relevant to increasing the delivery of science-based psychosocial treatment to adolescents with substance use disorders in a manner that is cost-effective and which may promote the adoption of effective treatment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 84
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of non-nicotine alcohol or drug use disorder

- English speaking

- Parental consent to participate for adolescents under the age of 18.

Exclusion Criteria:

- Clinical diagnosis of psychiatric disorders that require intensive level of services, such as active psychosis, active mania or active suicidality

- Plan to move out of the area within the next 3 months

- Insufficient ability to understand and provide informed consent/assent to participate

- Lack sufficient ability to use English to participate in the consent/assent process, the interventions or assessments

Study Design

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


Intervention

Behavioral:
Usual care
Participants will receive the usual care (e.g., individual therapy, group therapy, family therapy, self-help groups) provided at the treatment site.
Computer-delivered ACRA
Participants and willing caregivers will receive a computer-delivered intervention for 12 weeks, based on the Adolescent Community Reinforcement Approach to substance abuse treatment.

Locations

Country Name City State
United States National Development and Research Institutes, Inc.; St. Luke's-Roosevelt Hospital Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
National Development and Research Institutes, Inc. St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary substance use 16 weeks No
Primary acceptability of intervention 12 weeks No
Secondary HIV risk behavior 16 weeks No
Secondary psychosocial functioning 16 weeks No
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