- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00461487
A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents
Reducing Teen Sexual Behavior: A Clinic-Based Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10027
- Columbia University School of Social Work
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adolescent must be between the ages of 11 and 14 years old, and in grades 6, 7, or 8
- Adolescent is able to agree to being a participant
- Able to participate in questionnaire and intervention activities
- Latino or African-American descent
Exclusion Criteria:
- Any cognitive or psychiatric disability that would prevent successful participation in questionnaires and intervention activities
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Participants will receive sex education information during the physical exam
|
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.
|
|
Active Comparator: 2
Participants will receive information on hygiene and nutrition during the physical exam
|
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.
|
|
No Intervention: 3
Passive control participants will not receive any additional information during the physical exam
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of vaginal sexual intercourse measured
Time Frame: Measured at Months 3 and 12 post-treatment
|
Measured at Months 3 and 12 post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of condom use
Time Frame: Measured at Months 3 and 12 post-treatment
|
Measured at Months 3 and 12 post-treatment
|
|
Incidence of oral sex
Time Frame: Measured at Months 3 and 12 post-treatment
|
Measured at Months 3 and 12 post-treatment
|
|
Incidence of anal sex
Time Frame: Measured at Months 3 and 12 post-treatment
|
Measured at Months 3 and 12 post-treatment
|
|
Number of sexual partners
Time Frame: Measured at Months 3 and 12 post-treatment
|
Measured at Months 3 and 12 post-treatment
|
|
Behavioral intentions
Time Frame: Measured at Months 3 and 12 post-treatment
|
Measured at Months 3 and 12 post-treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vincent Guilamo-Ramos, PhD, Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AAAC1456
- DAHBR 9A-ASAP
- R34MH078719 (U.S. NIH Grant/Contract)
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