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Substance-Related DisordersFAMILYNCT01736995

Family and Adolescent Motivational Incentives for Leveraging Youth

A study testing Functional Family Therapy, Motivational Enhancement Tx/Cognitive Behavioral Tx and Contingency Management in people with Substance-Related Disorders, run by Oregon Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Substance-Related Disorders
What is being tested?
Functional Family Therapy, Motivational Enhancement Tx/Cognitive Behavioral Tx and Contingency Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
1 siteUnited States
Study dates
Jul 2012to Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oregon Research Institute Center for Family and Adolescent Research

    Albuquerque, New Mexico, 87102

Other trials in United States

About this study

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.

Read the detailed description

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 have 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 demonstrated the positive effects of contingency management (CM) methods on reductions in substance use and other problem behaviors such as HIV-risk, primarily with adults. CM has been shown to improve outcomes when combined with evidence-based practices and research is emerging to suggest that such integrations 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. Thus, participants will receive one of four intervention conditions, two with an integrated CM intervention (MET/CBT-CM, FFT-CM) and two without CM (MET/CBT, FFT). The study will employ a 2 (Incentives: CM, nonCM) x 2 (Modality: MET/CBT, FFT) x 5 (Time: Baseline, 2-, 4-, 8-, and 12-months post-randomization) factorial design. 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. Exploratory analyses will examine differences between modalities (MET/CBT vs FFT) on the presumed mediators. The investigators expect that MET/CBT will produce greater improvements in adolescents' drug avoidance self-efficacy and FFT will produce greater improvements in family relationships. 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.

The study addresses the question of whether adding a Contingency Management (CM) approach, in which adolescents are provided with a monetary incentive for providing clean urine, enhances the efficacy of two research-proven interventions for adolescent substance use. Specifically, the investigators compare if Functional Family Therapy (FFT) and Motivational Enhancement/Cognitive Behavioral Therapy (MET/CBT) combined with CM are better than either intervention alone. The investigators also explore the extent to which the addition of CM increases the speed with which adolescents achieve abstinence as well as the durability of these effects over time. The inclusion of two distinct forms of therapy also permits the investigation of how the interventions achieve their effects on adolescent drug use (e.g., improvements in family functioning in FFT vs. improvements in drug avoidance and self-efficacy skills in MET/CBT).

Specific Aim 1: To evaluate the efficacy of CM versus nonCM conditions delivered in the context of either group (MET/CBT) or family (FFT) treatments for substance abusing adolescents. The investigators will use two substance use dependent variables. The first variable assesses the presence or absence of illegal substances in urine samples collected weekly beginning at baseline and continuing during the 12-14 weeks of scheduled treatment. Urine samples will be collected at all post-randomization assessments. Although most of the adolescents are polydrug users, marijuana is the primary drug of abuse. The investigators anticipate that once weekly urine screens will be able to detect recent marijuana use. The Time Line Follow-back (TLFB) will be used to provide weekly estimates of drug use abstinence for a period from 3 months before to 12 months after randomization. Specifically, the investigators predict that the CM versus the nonCM conditions will produce a significant main effect increase in the number of weeks of drug use abstinence during the treatment phase (i.e., months 1-4; Hypothesis 1a) and during the post treatment period (i.e., 4-12 months; Hypothesis 1b).

Specific Aim 2: To evaluate the efficacy of CM versus nonCM on secondary behavioral outcomes. Specifically, The investigators predict that CM versus the nonCM conditions will be associated with significantly lower levels of sexually risky behaviors (Hypothesis 2a) and conduct problems (Hypothesis 2b) over time.

Specific Aim 3: To evaluate the effects of CM on hypothesized mediators of the MET/CBT and the FFT intervention effects. The investigators anticipate that the CM conditions are more likely than the nonCM conditions to accelerate the adolescent's motivation (1) to achieve abstinence, (2) to attend and participate in treatment, (3) to complete homework assignments. The SOCRATES scale will assess their motivation to achieve abstinence. Specifically, the investigators predict that youth receiving the CM versus nonCM will show higher rates of motivation for change at the 2-month assessment (Hypothesis 3a) and higher rates of treatment attendance and homework compliance (as measured by weekly therapist reports) over the course of treatment (Hypothesis 3b).

Exploratory Aims: The investigators will conduct exploratory analyses to examine if the number of continuous weeks of abstinence during treatment, adolescent's motivation to achieve abstinence, attendance, and homework compliance will mediate abstinence following treatment. Additional analyses will examine differences between modalities (MET/CBT vs FFT) on the presumed mediators: MET/CBT will produce greater improvements in adolescent's drug avoidance self-efficacy and FFT will produce greater improvements in family relationships (as measured by the FES). Improvements in drug avoidance self-efficacy and family relationships will mediate improvements in MET/CBT and FFT, respectively. The investigators will also explore potential differences within modality to determine if adding CM enhances the effects of each modalities impact on the presumed mediators of outcome. The results of these analyses will help determine if there is sufficient merit to warrant additional research into mechanisms of action within each modality. Finally, the investigators will conduct an informal cost-effectiveness analysis to derive preliminary estimates of the relative costs of each treatment modality, particularly with respect to treatment engagement/attendance and youth outplacement to restricted settings.

Being tested
Functional Family Therapy, Motivational Enhancement Tx/Cognitive Behavioral Tx, Contingency Management
Keywords
Substance Abuse, Adolescents, Families, Functional Family Therapy, Cognitive Behavioral Therapy, Motivational Therapy, Contingency Management
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Family TherapyBehavioural

    Also called FFT

  • Motivational Enhancement Tx/Cognitive Behavioral TxBehavioural

    Also called MET/CBT

  • Contingency ManagementBehavioural

    Also called CM

Study groups in NCT01736995
Study groupRoleWhat they receive
Motivational/Cog Beh Tx-Contingency MgmtExperimentalThe group Motivational Enhancement Tx/Cognitive Behavioral Tx (MET/CBT) treatment is a peer-focused, multi-component intervention involving 2 initial individual motivational sessions followed by 12 group sessions that includes a functional analysis of behavior to identify antecedents and consequences of drug use and skills training for coping with cravings, enhancing assertive communication, drug refusal, managing negative moods, problem-solving, decision-making, and relapse prevention. The additional inclusion of contingency management (CM) methods will provide immediate, tangible reinforcers as a consequence delivered contingently upon evidence of abstinence from substance use or other desirable behavior.
Receives: Behavioral: Contingency Management
Functional Family Tx- Contingency MgmtExperimentalFunctional Family Therapy (FFT) is a brief treatment for youth with problem behaviors, including substance abuse that consists of 12 to 14 weekly family sessions. The FFT treatment is applied in five distinct phases: Engagement, Motivation, Relational Assessment, Behavior Change, and Generalization and each phase has specific goals, techniques, and therapist skills. The additional inclusion of contingency management (CM) methods will provide immediate, tangible reinforcers to the family as a consequence delivered contingently upon evidence of abstinence from substance use or other desirable behavior.
Receives: Behavioral: Functional Family Therapy; Behavioral: Contingency Management
Motivational/Cog Beh TxExperimentalThe group Motivational Enhancement Tx/Cognitive Behavioral Tx (MET/CBT) treatment is a peer-focused, multi-component intervention involving 2 initial individual motivational sessions followed by 12 group sessions that includes a functional analysis of behavior to identify antecedents and consequences of drug use and skills training for coping with cravings, enhancing assertive communication, drug refusal, managing negative moods, problem-solving, decision-making, and relapse prevention.
Receives: Behavioral: Motivational Enhancement Tx/Cognitive Behavioral Tx
Functional Family TxExperimentalFunctional Family Therapy (FFT) is a brief treatment for youth with problem behaviors, including substance abuse that consists of 12 to 14 weekly family sessions. The FFT treatment is applied in five distinct phases: Engagement, Motivation, Relational Assessment, Behavior Change, and Generalization and each phase has specific goals, techniques, and therapist skills.
Receives: Behavioral: Functional Family Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 12-months after randomization

Secondary outcomes (1)
  1. 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.

    Measured: Up to 12-months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionApr 2018
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01736995
Sponsor's protocol ID
1R01DA032723-01A1
Acronym
FAMILY
Status last verified
May 2018
First submitted
5 Nov 2012
Last updated
2 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Functional Family Therapy, Motivational Enhancement Tx/Cognitive Behavioral Tx and Contingency Management in people with Substance-Related Disorders, run by Oregon Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urine Assays - NIDA 12 Test Panel (time frame: Up to 12-months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.

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