Substance-Related Disorders Clinical Trial
— FAMILYOfficial title:
Family and Adolescent Motivational Incentives for Leveraging Youth
NCT number | NCT01736995 |
Other study ID # | 1R01DA032723-01A1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2012 |
Est. completion date | April 2018 |
Verified date | May 2018 |
Source | Oregon Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Research has provided support for the efficacy of cognitive-behavioral and family interventions for adolescent substance use disorders (SUD), HIV-risk behaviors, and related problems. Despite support for these interventions, substantial heterogeneity in treatment outcomes and high relapse rates has been consistently found across studies. Such variability highlights the need for innovative strategies to broaden the impact and strengthen the durability of effects of adolescent substance abuse treatments. Over the past two decades, research has shown the positive effects of contingency management (CM) methods on reductions in substance use and other problem behaviors. When combined with evidence-based practices, emerging research suggests that CM integration may also be effective for adolescent substance abusers. The proposed Stage II efficacy trial examines the integration of CM with two empirically-supported interventions: group MET/CBT and FFT. By comparing two intervention modalities (group vs. family, the study provides a unique opportunity to examine the robustness of the effects of CM across established adolescent treatments, and to compare change mechanisms that may account for treatment outcomes. In the proposed research, substance abusing adolescents (n = 160) will be randomly assigned either to FFT or group MET/CBT. Random assignment will also be used to determine whether or not youth will receive a CM condition that provides incentives for abstinence (i.e., clean urine screens) and treatment participation. The primary aim of the study is to examine the efficacy of an integrated CM intervention for the two evidence-based treatments for adolescents, MET/CBT and FFT, compared to these treatments without CM on drug abuse abstinence (a) during treatment (i.e., speed of effects) and (b) at post-treatment follow-up assessments (i.e., durability of effects). A second aim of the study is to evaluate the effects of CM on hypothesized mediators of the intervention effects in the MET/CBT and the FFT conditions. The investigators anticipate that the CM conditions, compared to the nonCM conditions, are more likely to accelerate the adolescent's motivation (1) to achieve abstinence, to attend and participate in treatment, and to complete homework assignments. The investigators will also examine the effects of the interventions on HIV-risk behaviors and expect that CM will demonstrate the largest reductions in HIV-risk behaviors compared to the nonCM conditions.
Status | Completed |
Enrollment | 212 |
Est. completion date | April 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility |
Inclusion Criteria: - 13 to 17 years of age - Meets DSM-IV diagnostic criteria for substance abuse or dependence - Living at home with the participating parent - Sufficient residential stability to permit probable contact at follow- up(e.g., not homeless at time of intake) Exclusion Criteria: - Evidence of psychotic or organic state of sufficient severity to interfere with the understanding of study instruments and procedures - Deemed dangerous to self or others at intake - Services other than outpatient treatment are required for the youth (e.g., inpatient, detoxification) - Marijuana use is reported as being less than 13% of the previous 90 days |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Research Institute Center for Family and Adolescent Research | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
Oregon Research Institute | Dartmouth College |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine Assays - NIDA 12 Test Panel | The NIDA 12 Test Panel is a card device with 12 finger-like prongs, dipped in a urine sample to screen for the presence or absence of illegal substances including AMP (amphetamine), BAR (barbiturates), BZO (benzodiazepines), COC (cocaine), M-AMP/MDMA (methamphetamine, ice, speed, ecstasy), MTD (methadone), MOR (morphine), OXY (Oxycodone), PCP, PPX (Propoxyphene), OPI (Opiates), THC (marijuana). Alcohol use will be measured using Saliva Screens (Alco-Screen 02), a simple, non-invasive, one-step test that provides results in four minutes and detects alcohol levels of .02 or greater. | Up to 12-months after randomization | |
Secondary | Timeline Followback semi-structured interview (TLFB) | The TLFB will be used to determine the percent days of substance use (primary measure), excluding tobacco, as well as abstinence days and binge drinking days. | Up to 12-months after randomization |
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