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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00461487 |
Purpose
This study will evaluate the effectiveness of a parent-based intervention in reducing sexual risk behavior in high-risk Latino and African-American adolescents.
| Condition | Intervention |
|---|---|
|
Behavior and Behavior Mechanisms |
Behavioral: Active control on hygiene and nutrition Behavioral: Families Talking Together |
| Study Type: | Interventional |
| Study Design: | Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Reducing Teen Sexual Behavior: A Clinic-Based Approach |
| Estimated Enrollment: | 810 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will receive sex education information during the physical exam
|
Behavioral: Families Talking Together
The intervention will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. A mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. During this time, the intervention will be delivered to the mother. At the conclusion of the session, the mother will be given reference materials to take home and tasks to perform to facilitate discussions about sex with her adolescent. There will be three follow-up booster sessions administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents.
|
|
2: Active Comparator
Participants will receive information on hygiene and nutrition during the physical exam
|
Behavioral: Active control on hygiene and nutrition
The active control group will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. The mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. During this time, the active control on hygiene and nutrition will be delivered to the mother.
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3: No Intervention
Passive control participants will not receive any additional information during the physical exam
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In the United States, racial and ethnic minorities suffer disproportionately from preventable diseases and conditions. Many of these problems result from health-related behaviors that are established during childhood and adolescence. Latino and African-American adolescents are at considerable risk for the negative health consequences of early, risky sexual activity. This study will focus on inner-city Latino and African-American adolescents in grades 6, 7, and 8. The primary aim will be to develop an intervention that parents can use to address the issue of sexual risk behavior with their children.
The intervention will take place in a primary health care clinic when mothers accompany their children for annual physical exams. Mothers will meet with a social worker for approximately 25 minutes while their children are being examined by the physician. During this time, mothers will receive information about the problem of premature adolescent sexual activity, support in preventing or reducing their children's sexual risk behavior, instruction about how to talk with their children about sexual risk behavior, and targeted homework activities.
All parents will also receive three follow-up phone calls to increase the probability that the homework tasks will be completed.
Participants in this study will also be assigned to one of the following three groups: an experimental group; an active control group; or a passive control group. Participants in all groups will complete three questionnaires over the course of the study to assess outcomes. Participants in the experimental and active control groups will partake in an additional meeting with a clinic social worker. Parents in the experimental group will meet with the social worker to discuss effective parent-adolescent communication strategies. They will also receive take-home materials to help them communicate with and parent their adolescents to reduce sexual risk behavior.
Parents in the active control group will meet with the social worker to discuss adolescent nutrition and receive informational brochures.
Three booster sessions will take place via telephone for parents in the experimental and active control groups.
The first booster call will occur approximately 1 month after study entry, the second will occur 5 months after the intervention ends, and the third will occur 9 months post intervention. No such booster calls will be provided to parents in the passive control condition.
Eligibility| Ages Eligible for Study: | 11 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Columbia University School of Social Work | |
| New York, New York, United States, 10027 | |
| Principal Investigator: | Vincent Guilamo-Ramos, PhD | Columbia University |
More Information
| Responsible Party: | Columbia University School of Social Work ( Vincent Guilamo-Ramos ) |
| Study ID Numbers: | R34 MH078719, DAHBR 9A-ASAP |
| Study First Received: | April 16, 2007 |
| Last Updated: | April 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00461487 History of Changes |
| Health Authority: | United States: Federal Government |
|
Adolescent Behavior Communication Health Behavior Risk-Taking Sexual Behavior |
