CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 190 enrolled
Drug / intervention
Family Therapy based on Structural Family Therapy +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01823250
NCT01823250Phase 2Completed

Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial

University of Miami·interventional·Posted Apr 4, 2013·Updated Dec 16, 2015

In Brief

A Phase 2 clinical trial evaluating Family Therapy based on Structural Family Therapy, Group Therapy, and 2 other interventions for Substance Use Disorders and 3 related conditions. Completed, enrolled 190 participants across 1 site.

Detailed Summary

This Stage II randomized trial tests Culturally Informed \& Flexible Family Based Treatment for Adolescents (CIFFTA) developed as part of a Stage I treatment development effort and yielding promising preliminary findings. Drug use rates are highest among Hispanic middle school youth and to date no treatments have met criteria for "Well Established" in the treatment of substance abuse in Hispanic adolescents. Further treatment for Hispanic youth and families is complicated by the fact that these families often differ from mainstream populations in culture-related values, beliefs and behaviors that can directly impact engagement, retention, and efficacy/effectiveness of drug treatment. Our efforts to develop a more powerful treatment capable of addressing these issues began with a Stage 1 study that led to the development of a multi-component treatment that includes a flexible manual that allows treatment tailoring to the unique characteristics of individual families. CIFFTA integrates innovative culturally-based, individually-based, and family-based components to: 1) reduce maladaptive family processes (e.g., poor parenting practices, family conflict) and increase family protective factors (e.g., strong parent-child attachment), 2) teach adolescents skills to effectively manage interpersonal conflicts and stressors and to increase motivation to change, 3) deliver psycho-educational and culturally congruent material (e.g., modules on immigration stressors) to youth and parents both separately and together, and 4) deliver the intervention using a flexible treatment manual that allows the clinician to tailor the treatment (e.g., by selecting the most relevant psycho-educational modules and themes) to the unique characteristics and needs of the Hispanic family. This Stage II randomized trial randomizes 220 Hispanic adolescents ages 14-17 who meet DSM-IV criteria for Substance Abuse to a 4-month treatment of either CIFFTA or Traditional Family Therapy. The study tests CIFFTA's efficacy in impacting drug use, risky sexual behavior, and other severe behavior problems, and hypothesized mechanisms of change, in a larger and more rigorous Stage II trial. Assessments occur at baseline, 4 months post baseline (end of treatment), 10 months post baseline and 16 months post baseline. Should this line of research continue to be successful, it has the potential to contribute to the field a highly innovative and efficacious treatment for Hispanic drug abusing adolescents, a better understanding of mechanisms of treatment efficacy, and also a framework for future flexible and tailored treatments that can be used to better address the unique needs of other special populations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2013
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.2 years ago

Interventions

Family Therapy based on Structural Family Therapybehavioral

Once per week family therapy based on Structural Family Therapy. Sees to improve parenting practices, communication, and problem solving skills. It also seeks to increase the attachment/bond between parents and adolescents.

Group Therapybehavioral

Group Therapy is provided once per week and is designed to share information on HIV and STI risk and protection. There are typically 8-10 adolescents in a group.

Psychoeducational Sessionsbehavioral

Psycho-educational sessions are used to provide didactic in formation to parents alone, adolescents alone, or both together. Content may focus on parenting, drug use risks, depression, HIV/STI risk or other major issues that adolescents and families confront. There are also modules that focus on culture-related stressors and processes that can be provided to families for whom this is a prominent issue.

Individual Adolescent Therapy Sessionsbehavioral

Individual sessions with the adolescent focus on Motivational Interviewing, coaching for family sessions, and monitoring of unhealthy behaviors.