Preventing Health Disparities in Hispanic Youth

NCT02318745 | Completed

• 2 other identifiers: 20070334P60MD002266
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study seeks to investigate the efficacy and mechanisms of a highly promising "Culturally Informed Family Therapy for Adolescents" in preventing the emergence of two important health disparities in Hispanic youth, namely drug use \& HIV and other sexually transmitted infections (STI). The proposed study is submitted as part of a P60 application entitled "NCMHD Center for Culturally-Tailored Hispanic Health Disparities Research (El Centro)", in response to the NIH RFA-MD-06-002: Establishing Comprehensive NCMHD Research Centers of Excellence. This study investigates: 1) the efficacy of the treatment in reducing existing psychiatric, behavioral and family problems in youth, and 2) the indicated prevention effects of the intervention on the emergence of drug use and HIV/STI 20 months after baseline. There is a substantial literature linking disruptive behaviors (i.e., conduct disorder and attention deficit hyperactivity disorder) and mood instability (i.e., depressive disorders) and family conflict to the development of the Hispanic health disparities of drug use and HIV/STI. Conduct disorder (CD), attention deficit hyperactivity disorder (ADHD) and depressive disorders (DD) will be targets of treatment, as will be the family risk factors (e.g., poor parenting, family conflict) and acculturation-related stressors, all of which have been shown to place youth on a destructive trajectory toward deteriorating health.

Conditions

ADHD; Conduct Disorder; Depression; Family Dysfunction

Keywords

Family Therapy; Substance abuse prevention; Minority; randomized trials; outcome research; adolescent treatment

Outcome Measures

Primary Outcomes (5)

• Child Behavior Checklist Change Measure

  The Child Behavior Checklist (CBCL; Achenbach, 1991) was used as the parent report of youth's problem behaviors. Problem behaviors were scored along the dimensions of the super-ordinate domains of "internalizing" and "externalizing" behaviors. Smaller syndromes of behavior problems (e.g. delinquent behavior, aggressive behavior, anxious/depressed) were also available. The two syndromes that comprise the externalizing dimension, delinquent behavior and aggressive behavior were used as indicators of behavior problems, whereas the anxious/depressed dimension was used as an indicator of internalizing problems. Internal consistency reliabilities of each of the subscales ranged from .73 to .90.

  Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)

• Youth Self Report Change Measure

  The Youth Self-Report (YSR; Achenbach, 1991) was used as the adolescent (11-18 years old) self-report instrument to assess problem behaviors, and the degree of functioning on three dimensions of Social Competence. Problem behaviors were scored along the dimensions of the super-ordinate domains of "internalizing" and "externalizing" behaviors. As with the CBCL, smaller syndromes of behavior problems (e.g. delinquent behavior, aggressive behavior, anxious/depressed) were also available. The two syndromes that comprised the externalizing dimension, delinquent behavior and aggressive behavior were used as indicators of behavior problems, whereas the anxious/depressed dimension was used as an indicator of internalizing problems. Internal consistency reliabilities of each of the subscales ranged from .72 to .90.

  Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)

• Diagnostic Interview Schedule for Children - Predictives Change Measure

  The Diagnostic Interview Schedule for Children - Predictive Scales (DISC-P; Lucas et al., 1997) was used to evaluate psychiatric symptoms in a standardized manner consistent with DSM diagnostic criteria. For this study, the Attention Deficit Hyperactivity Disorder, Depression, Oppositional Defiant Disorder, and Conduct Disorder components of the measure were used. The DISC-P has been found to have a high degree of sensitivity with respect to the DISC for specific DPS scales. The DISC-P was administered to both parents and children.

  Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)

• Substance Use and Attitudes Regarding Substance Use Change Measure

  We combined items from several instruments. Items extracted from the Monitoring the Future Study (Johnston, O'Malley, \& Bachman, 2003) asked whether or not the adolescent had used cigarettes, alcohol, and other illegal substances. Adolescents who responded to using an illegal substance were asked to respond to the type of substance used, age of first use, and the frequency of use in the past 30 days. Items from the CSAP National Student Survey (1996), and the USC Health Behaviors Survey (Pentz, et al., 1989) measured attitudes toward tobacco, alcohol, and illegal substances, intentions regarding substance use, the degree to which adolescents care about how others would view them if they used drugs or alcohol, and perceptions of parents, peers, teachers approval/ disapproval of respondent's tobacco, alcohol, or other drug use. High internal consistency for the attitudes, intentions, and social norms subscales have been found (.92, .99, and .97, respectively).

  Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)

• Adolescent Risky Sexual Behaviors Change Measure

  Questions from several instruments were combined into one gated instrument to assess a range of sexual risky situations and behaviors in the youth. Some questions from the Interview on Situations of Sexual Possibility- Booklet A (ISSP; Paikoff, 1995), a gated, structured interview about unsupervised peer activities, situations of sexual possibility, and other questions from the Sexual Behavior instrument (Jemmot, Jemmot, \& Fong, 1998), that assess the adolescent's sexual behavior, condom use, and existence of a sexually transmitted disease during their lifetime and in the past three months were combined. There was a total of 19 items in the questionnaire, however, the instrument is gated and not all questions were asked. Depending on the types of risky situations the adolescent had been involved in, the questions become more specific about risky sexual involvement or the instrument was discontinued if the adolescent had not been exposed to certain behaviors.

  Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)

Secondary Outcomes (4)

• Family Environment Scales Change Measure

  Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)

• Parenting Practices Questionnaire Change Measure

  Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)

• Parental Monitoring Change Measure

  Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)

• Parent Child Attachment Change Measure

  Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)

Study Arms (2)

Culturally Informed Family Treatment for Adolescents

EXPERIMENTAL

CIFTA focuses on improving parenting practices, parent-adolescent attachment, adolescent ability to meet developmental challenges, increasing family support and decreasing family conflict/negativity, increasing knowledge of drug effects and triggers to use. Parents are taught general parenting and how to help a son or daughter with depression, conduct problems, and/or ADHD. Psycho-educational modules complement the family therapy and culturally relevant information is infused throughout the treatment. In family therapy sessions family members practice the skills and psycho-educational material they have learned. Treatment last approximately 4 months and includes approximately 6 session per month. Session may be family therapy sessions, individual sessions, or psycho-educational modules.

Behavioral: Culturally Informed Family Treatment for Adolescents

Individual Treatment As Usual

ACTIVE COMPARATOR

The active comparison condition reflects the typical individually-oriented services that behavior problem youth receive in the community. It was designed to isolate the effects of the CIFTA family interventions. A community agency helped us to standardize the individually-oriented services that were normally provided and a therapist trained by that agency was hired to work on the study to provide continuity to the services. The adolescent individual sessions addressed depression, ADHD, and/or conduct disorder through Cognitive Behavior Therapy, Interpersonal psychotherapy, social skills training, anger control training, problem solving skills, and assertiveness training. The ITAU therapists were expected to hold 6 sessions per month with the youth.

Behavioral: Individual Treatment

Interventions

Culturally Informed Family Treatment for Adolescents BEHAVIORAL

Family Therapy, Psycho-educational Modules, Individual therapy sessions

Culturally Informed Family Treatment for Adolescents

Individual Treatment BEHAVIORAL

Cognitive Behavior Therapy, Interpersonal psychotherapy, social skills training, anger control training, problem solving skills, assertiveness training, and the Empty chair technique from Gestalt therapy

Individual Treatment As Usual

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• year old Hispanic youngsters meeting DISC-Predictives cut-off scores for two or more disorders (including CD, ADHD, and
• DD \[any of the depressive disorders\]) and/or family conflict were included in the study along with their families.

You may not qualify if:

• Participants who meet any of the following will be excluded:
• 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, and Bipolar Affective Disorder,
• Any Substance Abuse or Dependence Disorder diagnosis (substance use that does not meet DSM IV diagnosis criteria will not excluded).

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Conduct Disorder; Depression

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist/Professor

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 17, 2014
• Study Start: June 1, 2007
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 17, 2014

Record last verified: 2014-12