Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial (CIFFTA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Miami
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Daniel A. Santisteban, Ph.D., University of Miami
ClinicalTrials.gov Identifier:
NCT01823250
First received: June 11, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Substance Use Disorders
Risk Behavior
Psychiatric Disorders
Family Dysfunction
Behavioral: Family Therapy based on Structural Family Therapy
Behavioral: Group Therapy
Behavioral: Psychoeducational Sessions
Behavioral: Individual Adolescent Therapy Sessions
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Change in Adolescent Drug Use [ Time Frame: At baseline, twice per month during the 4 month treatment phase (collection weeks randomly assigned), and 4, 10, and 16 months post baseline. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Changes in Service Utilization Interview (SUI) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    The SUI documents mental health and family services received from 11 types of professionals (e.g. psychologist, psychiatrist) and 15 kinds of groups (e.g. church group, support group), and frequency, reason, and duration of service. Additionally, the SUI captures whether or not any family member has been in contact with law enforcement or the courts (Center for Family Studies, 1995). The SUI (mental health and legal) will be administered to parents at all the formal time-points, and 6, 8, 12 and 14 month post-baseline calls. The SUI takes 15 minutes to complete.

  • Change in Personal Experiences Inventory (PEI) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    The PEI is an adolescent self-report measure of involvement with drugs, and degree of psychological and social consequences that takes 10 minutes to complete. Its well-documented psychometric properties are satisfactory (Winters & Henly, 1989).

  • Change in Risky Sexual Behavior (SRB) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    Questions ask about the adolescent's number of sexual partners in the past 3 months, frequency of engagement in oral, anal and vaginal intercourse over the past 3 months, and for each occurrence how many times a condom was used, and how many times they were high on alcohol and/or drugs. In our work with Hispanic adolescents, scales for HIV knowledge and intentions showed acceptable internal consistency (alpha) coefficients (.66 to .76).

  • Change in Behavior Problem Checklist (RBPC) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    The RBPC (Quay & Peterson, 1987) assesses problem behaviors as reported by parents. Three subscales (50 items) will be used in this study: Conduct Disorder, Socialized Aggression, and Anxiety/Withdrawal. Adolescent problem behaviors are rated (0 = No problem; 1 = mild problem; 2 = severe problem).Psychometric properties with Spanish speaking patients found to be adequate: internal consistency (alpha) coefficients above .89, test-retest reliability coefficients between .49 and .83, and inter-parent reliability between .59 and .87.

  • Change in Youth Self-Report (YSR) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    The YSR (Achenbach, 1991) is an adolescent (11-18 years old) self-report instrument that assesses the severity of 119 problem behaviors, and the degree of functioning on three dimensions of Social Competence. Problem behaviors can be scored on the super-ordinate domains of "internalizing" and "externalizing" behaviors, or smaller syndromes of behavior problems. The Spanish YSR scales have shown good internal consistency (alpha > .90) in our past work with Hispanic adolescents. The YSR takes about 25 minutes to administer.

  • Change in Youth Outcome Questionnaire (YOQ) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    The Interpersonal Relations and Social Problems scales from the YOQ (Burlingame, Wells, & Lambert, 1996) will be used in this study. The YOQ was developed for children and adolescents ages 4-17 to track therapeutic progress. The Interpersonal Relations scale measures children's interactions, aggressiveness, and arguments with peers and adults. The Social Problems scale measures problematic behaviors such as running away, truancy, and destroying property. Internal consistency estimates of subscales range from .74 to .93 with a total scale score of .96.

  • Change in Parenting Practices Questionnaire (PPQ) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    The PPQ (Gorman-Smith et al., 1995) assesses four dimensions of parenting behavior: positive parenting, discipline effectiveness, discipline avoidance, and extent of involvement. Parents report on all four dimensions; adolescents report only on positive parenting and extent of involvement. The reliability of the PPQ has been supported by confirmatory factor analysis, with internal consistency coefficients ranging from .68 to .81. In our work with Hispanic adolescents, the PPQ subscales showed acceptable internal consistency (alpha) coefficients (.74 to .93).

  • Change in Parental Monitoring Instrument (PMI) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    The PMI (Cottrell et.al. 2007) was developed to determine how often parents use seven monitoring strategies: direct monitoring, indirect monitoring, school, health, computer, phone, and restrictive. The scale contains 27 items with 4 frequency responses (0 times, 1 to 2 times, 3 to 4 times, and 5-plus times). Parents and adolescents report how many times parents used a specific monitoring strategy in the past 4 months. In the development study, PMI has shown acceptable internal consistency (alpha) coefficients for parents (.71 to .85) and adolescents (.71 to .81).

  • Change in Family Environment Scale (FES) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    The FES is a brief 18-item self-report scale (Moos & Moos, 1994). Only two subscales are used in this study. The Cohesion scale measures the extent to which the adolescent or parent views the family as harmonious and close. The Conflict scale measures the extent to which the adolescent or parent views the family as characterized by frequent quarrels and disagreements. In our work with Hispanic adolescents, the FES showed acceptable internal consistency (alpha) coefficients (.69 to .81) and test-retest reliability (.85 to .86) at two-months.

  • Change in Inventory of Parent and Peer Attachment (IPPA) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    The IPPA (Armsden & Greenberg, 1987) is a self-report measure of adolescents' perception of their attachment to their parents along three dimensions: degree of mutual trust, quality of communication and the extent of anger and alienation. Internal consistency (alpha) coefficients are .87 for the mother version and .89 for the father version.

  • Change in Parent Barriers to Talk About Sex [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    Parents will be administered 31 items from a larger measure used in the National Longitudinal Adolescent Health Questionnaire, which ask about parental attitudes and behaviors with regards to speaking with their adolescents about sex and birth control (Bearman, Jones, Jo, & Udry, 1997).

  • Change in Caregiver strain questionnaire (CGSQ) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    The CGSQ measures self-reported strain experienced by caregivers and families of youth. For each of the scale's 21 items, caregivers are asked to rate how much of a problem each item was for them. Impact areas covered by the CGSQ include family relations, time demands, psychological adjustment, financial burden, stigma, anger, and worry/guilt.

  • Change in Working Alliance Inventory (WAI) [ Time Frame: At baseline and 4, 10, and 16 months post randomization. ] [ Designated as safety issue: No ]
    The WAI (Horvath and Greenberg, 1989) is a 10-minute measure of the quality and strength of the alliance between therapist and client on three dimensions: Goal, Task, and Bond. Reported reliabilities for the therapist version were .87 for the Goal scale, .82 for the Task scale and .68 for the Bond scale. For the client version, reliabilities of .89 for the Goal scale, .92 for both the Task and Bond scale.


Estimated Enrollment: 220
Study Start Date: January 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CIFFTA
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
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.
Behavioral: Psychoeducational Sessions
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.
Behavioral: Individual Adolescent Therapy Sessions
Individual sessions with the adolescent focus on Motivational Interviewing, coaching for family sessions, and monitoring of unhealthy behaviors.
Active Comparator: Traditional Family Therapy (TFT)
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
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.
Behavioral: Group Therapy
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823250

Contacts
Contact: Maite P. Mena, Psy.D. 3052845119 mmena@miami.edu
Contact: Marc J. Puccinelli, M.Ed. 3052844186 m.puccinelli@miami.edu

Locations
United States, Florida
Gables Waterway Executive Center (Clinic) Recruiting
Miami, Florida, United States, 33146
Contact: Maite P. Mena, Psy.D.    305-284-5119    mmena@miami.edu   
Contact: Daniel A. Santisteban, Ph.D.    3052844271    dsantist@miami.edu   
Principal Investigator: Daniel A. Santisteban, Ph.D.         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Daniel A. Santisteban, Ph.D. University of Miami
Study Director: Maite P. Mena, Psy.D. University of Miami
  More Information

Publications:
Responsible Party: Daniel A. Santisteban, Ph.D., Clinical Psychologist/Research Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01823250     History of Changes
Other Study ID Numbers: 20100055, R01DA027920-01
Study First Received: June 11, 2012
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Hispanic
adolescent
drug abuse treatment
evidence-based
family therapy
adaptive family treatment
Culturally Informed and Flexible Family-Based Treatment for Adolescents

Additional relevant MeSH terms:
Substance-Related Disorders
Disease
Mental Disorders
Chemically-Induced Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014