Substance Use Disorders Clinical Trial
— CIFFTAOfficial title:
Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial
Verified date | December 2015 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 190 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years to 17 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Gables Waterway Executive Center (Clinic) | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | National Institute on Drug Abuse (NIDA) |
United States,
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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.
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.
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | Changes in Service Utilization Interview (SUI) | 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. | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Personal Experiences Inventory (PEI) | 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). | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Risky Sexual Behavior (SRB) | 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). | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Behavior Problem Checklist (RBPC) | 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. | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Youth Self-Report (YSR) | 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. | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Youth Outcome Questionnaire (YOQ) | 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. | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Parenting Practices Questionnaire (PPQ) | 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). | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Parental Monitoring Instrument (PMI) | 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). | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Family Environment Scale (FES) | 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. | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Inventory of Parent and Peer Attachment (IPPA) | 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. | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Parent Barriers to Talk About Sex | 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). | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Caregiver strain questionnaire (CGSQ) | 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. | At baseline and 4, 10, and 16 months post randomization. | No |
Secondary | Change in Working Alliance Inventory (WAI) | 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. | At baseline and 4, 10, and 16 months post randomization. | No |
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