A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents
Reducing Teen Sexual Behavior: A Clinic-Based Approach
2 other identifiers
interventional
1,800
1 country
1
Brief Summary
The purpose of this study is to test the feasibility and efficacy of a triadic intervention designed to target both healthcare providers and parents in order to prevent adolescent sexual risk behavior in Latino and African American adolescents. The intervention will be administered in the context of mothers waiting for their children to complete a non-acute care visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 31, 2011
CompletedStudy Start
First participant enrolled
February 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2016
CompletedOctober 27, 2022
April 1, 2019
4.3 years
March 28, 2011
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of vaginal intercourse
Measured at 12 months post-intervention
Incidence of condom use
Measured at 12-months post-intervention
Secondary Outcomes (6)
Number of sexual partners
Measured at 12 months post-intervention
Behavioral intentions
Measured at 12 months post-intervention
Incidence of vaginal intercourse
Measured at 3 months post-intervention
Incidence of condom use
Measured at 3 months post-intervention
Number of sexual partners
Measured at 3 months post-intervention
- +1 more secondary outcomes
Study Arms (3)
Sex Education + Standard Care
EXPERIMENTALParticipating mothers will receive sex education information while their child is having a physical exam.
Hygiene & Nutrition Education + Standard Care
ACTIVE COMPARATORParticipating mothers will receive information on hygiene and nutrition while their child is having a physical exam.
No Education + Standard Care
NO INTERVENTIONParticipating mothers who are passive controls will not receive any additional information while their child is having a physical exam.
Interventions
The intervention will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth fora non-acute care visit. A mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. 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. The healthcare provider will endorse the intervention separately for mothers and adolescents. There will be one follow-up booster session administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents.
The active control group will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth for a non-acute care visit. The mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. During this time, the active control on hygiene and nutrition will be delivered to the mother.
Eligibility Criteria
You may qualify if:
- Adolescents must be between the ages of 11 and 14 years old
- Adolescent is able to agree to being a participant
- Participant must be able to participate in questionnaire and intervention activities
- Participant must be of Latino or African American descent
You may not qualify if:
- Any cognitive or psychiatric disability that would prevent successful participation in questionnaire or intervention activities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University
New York, New York, 10003, United States
Related Publications (1)
Guilamo-Ramos V, Benzekri A, Thimm-Kaiser M, Dittus P, Ruiz Y, Cleland CM, McCoy W. A Triadic Intervention for Adolescent Sexual Health: A Randomized Clinical Trial. Pediatrics. 2020 May;145(5):e20192808. doi: 10.1542/peds.2019-2808.
PMID: 32345685DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Guilamo-Ramos, PhD, ANP-BC
New York University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2011
First Posted
March 31, 2011
Study Start
February 15, 2012
Primary Completion
May 31, 2016
Study Completion
May 31, 2016
Last Updated
October 27, 2022
Record last verified: 2019-04