Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial

NCT01823250 | Completed Phase 2

• 2 other identifiers: 20100055R01DA027920-01
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Use Disorders; Risk Behavior; Psychiatric Disorders; Family Dysfunction

Keywords

Hispanic; adolescent; drug abuse treatment; evidence-based; family therapy; adaptive family treatment; Culturally Informed Family-Based Treatment for Adolescents

Outcome Measures

Primary Outcomes (1)

• Change in Adolescent Drug Use

  Drug use will be assessed using the Time-Line Follow-Back Drug Use Recording Method (TLFB) and a Urine Drug Screen kit. The latter is a self contained testing unit which combines a temperature sensitive collection cup with built in assays for sample adulterants and 9 specific drugs of abuse. The TLFB has been adapted for adolescents and obtains retrospective adolescent reports of daily substance use by using a calendar to stimulate recall. It gathers information on specific substances used, amount of use, social context of use, location of use, and subjective experience of use.

  At baseline, twice per month during the 4 month treatment phase (collection weeks randomly assigned), and 4, 10, and 16 months post baseline.

Secondary Outcomes (13)

• Changes in Service Utilization Interview (SUI)

  At baseline and 4, 10, and 16 months post randomization.

• Change in Personal Experiences Inventory (PEI)

  At baseline and 4, 10, and 16 months post randomization.

• Change in Risky Sexual Behavior (SRB)

  At baseline and 4, 10, and 16 months post randomization.

• Change in Behavior Problem Checklist (RBPC)

  At baseline and 4, 10, and 16 months post randomization.

• Change in Youth Self-Report (YSR)

  At baseline and 4, 10, and 16 months post randomization.

Study Arms (2)

CIFFTA

EXPERIMENTAL

Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA)involves four months of intervention. Adolescents and families receive one family therapy session per week and an additional session which is either a psycho-educational session for the adolescent and/or parents, or an individual therapy session with the adolescent. There is a total of 2 sessions per week.

Behavioral: Family Therapy based on Structural Family Therapy; Behavioral: Psychoeducational Sessions; Behavioral: Individual Adolescent Therapy Sessions

Traditional Family Therapy (TFT)

ACTIVE COMPARATOR

The Traditional Family Therapy condition consists of once per week family therapy based on Structural Family Theory and a didactic group intervention once per week in which HIV/STI risk is discussed.

Behavioral: Family Therapy based on Structural Family Therapy; Behavioral: Group Therapy

Interventions

Family Therapy based on Structural Family Therapy BEHAVIORAL

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.

CIFFTA; Traditional Family Therapy (TFT)

Group Therapy BEHAVIORAL

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.

Traditional Family Therapy (TFT)

Psychoeducational Sessions BEHAVIORAL

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.

CIFFTA

Individual Adolescent Therapy Sessions BEHAVIORAL

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

CIFFTA

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The adolescent has a substance abuse disorder,
• The adolescent is 14 to 17 years old, and
• The adolescent is living with at least one family member of an older generation born in a Spanish-speaking country such as a parent or grandparent

You may not qualify if:

• History of any of the following DSM IV diagnoses:
• Developmental Disorders
• Elective Mutism
• Organic Mental Disorders (except Psychoactive Substance-Induced)
• Schizophrenia
• Delusional (Paranoid) Disorder
• Psychotic Disorder
• Bipolar Affective Disorder

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Gables Waterway Executive Center (Clinic)

Miami, Florida, 33146, United States

Location

Related Publications (9)

• Huey SJ Jr, Polo AJ. Evidence-based psychosocial treatments for ethnic minority youth. J Clin Child Adolesc Psychol. 2008 Jan;37(1):262-301. doi: 10.1080/15374410701820174.

  PMID: 18444061 BACKGROUND

• Santisteban DA, Mena MP, McCabe BE. Preliminary results for an adaptive family treatment for drug abuse in Hispanic youth. J Fam Psychol. 2011 Aug;25(4):610-4. doi: 10.1037/a0024016.

  PMID: 21639636 BACKGROUND

• Santisteban DA, Mena MP. Culturally informed and flexible family-based treatment for adolescents: a tailored and integrative treatment for Hispanic youth. Fam Process. 2009 Jun;48(2):253-68. doi: 10.1111/j.1545-5300.2009.01280.x.

  PMID: 19579908 BACKGROUND

• Santisteban DA, Tejeda M, Dominicis C, Szapocznik J. An efficient tool for screening for maladaptive family functioning in adolescent drug abusers: the Problem Oriented Screening Instrument for Teenagers. Am J Drug Alcohol Abuse. 1999 May;25(2):197-206. doi: 10.1081/ada-100101855.

  PMID: 10395155 BACKGROUND

• Santisteban, D., Szapocznik, J., Perez-Vidal, A., Kurtines, W. M., Coatsworth, J.D., et al. (1996). Efficacy of intervention for engaging youth and families into treatment and some variables that may contribute to differential effectiveness. Journal of Family Psychology, 10, 35-44.

  BACKGROUND

• Santisteban, D.A., & Szapocznik, J. (1994). Bridging theory, research and practice to more successfully engage substance abusing youth and their families into therapy. Journal of Child and Adolescent Substance Abuse, 32 (2), 9-24.

  BACKGROUND

• Szapocznik, J., Hervis, O., & Schwartz, S. (2003) Brief Stategic Family Therapy for Adolescent Drug Abuse. Therapy Manuals for Drug Addiction. U.S. Department of Health and Human Services. Bethesda, Maryland.

  BACKGROUND

• Santisteban DA, Muir JA, Mena MP, Mitrani VB. INTEGRATIVE BORDERLINE ADOLESCENT FAMILY THERAPY: MEETING THE CHALLENGES OF TREATING ADOLESCENTS WITH BORDERLINE PERSONALITY DISORDER. Psychotherapy (Chic). 2003 Winter;40(4):251-264. doi: 10.1037/0033-3204.40.4.251.

  PMID: 25663719 BACKGROUND

• Bry BH, Krinsley KE. Booster sessions and long-term effects of behavioral family therapy on adolescent substance use and school performance. J Behav Ther Exp Psychiatry. 1992 Sep;23(3):183-9. doi: 10.1016/0005-7916(92)90035-h.

  PMID: 1487536 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Risk-Taking; Mental Disorders

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Behavior

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Daniel A. Santisteban, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

• Maite P. Mena, Psy.D.

  University of Miami

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist/Professor

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: April 4, 2013
• Study Start: January 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

US (1)