Depression Clinical Trial
— CIFFTA-POfficial title:
Preventing Health Disparities in Hispanic Youth
Verified date | December 2014 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 11 Years to 14 Years |
Eligibility |
Inclusion Criteria: - 11-14 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. Exclusion Criteria: - 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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Miami | National Institute on Minority Health and Health Disparities (NIMHD) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Primary | 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) | No |
Primary | 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) | No |
Primary | 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) | No |
Primary | 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) | No |
Secondary | Family Environment Scales Change Measure | The Cohesion and Conflict scales from the FES (Moos & Moos, 1994) were be used in this study. The Cohesion scale measured the extent to which the adolescent or parent views the family as harmonious and close. The Conflict scale measured the extent to which the adolescent or parent views the family as characterized by frequent disagreements. These two constructs have been found to be among the strongest family-based correlates of adolescent problem behavior. Moreover, these two scales (18 items) have been used successfully in previous research conducted by the investigator on adolescent treatment outcomes (Santisteban, Coatsworth, et al., 2003). Internal consistencies based on data from a normative sample for the cohesion and conflict scales were .78 and .75, respectively. Parents and youth completed this questionnaire and internal consistency reliabilities ranged from .67 to .76 for the parents and from .75 to .76 for the youth. | Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline) | No |
Secondary | Parenting Practices Questionnaire Change Measure | Parenting Practices Questionnaire (PPQ). The Parenting Practices Questionnaire (Gorman-Smith et al., 1995) from the Chicago Youth Development Study was used to assess four dimensions of parenting behavior: Positive Parenting, Discipline effectiveness, Discipline Avoidance and Extent of Involvement. Positive parenting and extent of involvement were assessed only in the adolescents. Internal consistency reliabilities of each of the subscales ranged from .64 to .80 in the parents and .76 to .87 in the adolescents. | Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline) | No |
Secondary | Parental Monitoring Change Measure | Parental Monitoring Instrument. 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 reported how many times parents used a specific monitoring strategy in the past 4 months. Internal consistency reliabilities were .88 and .83 for the parents and youth, respectively. | Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline) | No |
Secondary | Parent Child Attachment Change Measure | Parent-Adolescent Attachment. The Inventory of Parent and Peer Attachment (IPPA) (Armsden & Greenberg, 1987) was used to assess adolescents' perception of the positive and negative aspects of their attachment to their parents. The IPPA measures three dimensions: degree of mutual trust, quality of communication, and the extent of alienation. Internal consistency reliabilities of each of the subscales ranged from .76 to .91. | Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline) | No |
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