NCT00461487

Brief Summary

This study will evaluate the effectiveness of a parent-based intervention in reducing sexual risk behavior in high-risk Latino and African-American adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
530

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

2.3 years

First QC Date

April 16, 2007

Last Update Submit

July 9, 2013

Conditions

Behavior and Behavior Mechanisms

Keywords

Adolescent BehaviorCommunicationHealth BehaviorRisk-TakingSexual Behavior

Outcome Measures

Primary Outcomes (1)

  • Incidence of vaginal sexual intercourse measured

    Measured at Months 3 and 12 post-treatment

Secondary Outcomes (5)

  • Incidence of condom use

    Measured at Months 3 and 12 post-treatment

  • Incidence of oral sex

    Measured at Months 3 and 12 post-treatment

  • Incidence of anal sex

    Measured at Months 3 and 12 post-treatment

  • Number of sexual partners

    Measured at Months 3 and 12 post-treatment

  • Behavioral intentions

    Measured at Months 3 and 12 post-treatment

Study Arms (3)

1

EXPERIMENTAL

Participants will receive sex education information during the physical exam

Behavioral: Families Talking Together

2

ACTIVE COMPARATOR

Participants will receive information on hygiene and nutrition during the physical exam

Behavioral: Active control on hygiene and nutrition

3

NO INTERVENTION

Passive control participants will not receive any additional information during the physical exam

Interventions

Active control on hygiene and nutritionBEHAVIORAL

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.

2
Families Talking TogetherBEHAVIORAL

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.

1

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Any cognitive or psychiatric disability that would prevent successful participation in questionnaires and intervention activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University School of Social Work

New York, New York, 10027, United States

Location

Related Publications (1)

  • Guilamo-Ramos V, Bouris A, Jaccard J, Gonzalez B, McCoy W, Aranda D. A parent-based intervention to reduce sexual risk behavior in early adolescence: building alliances between physicians, social workers, and parents. J Adolesc Health. 2011 Feb;48(2):159-63. doi: 10.1016/j.jadohealth.2010.06.007.

    PMID: 21257114DERIVED

MeSH Terms

Conditions

BehaviorAdolescent BehaviorCommunicationHealth BehaviorRisk-TakingSexual Behavior

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Vincent Guilamo-Ramos, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 18, 2007

Study Start

April 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2010

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(1)