NCT00963963

Brief Summary

This study is developing and testing an innovative, parent education intervention, Preparing Our Sons and Daughters for Healthy Futures. This intervention aims to reduce HIV risk among African American and other Black youth living in high-poverty urban neighborhoods. Investigators, working with a community advisory board and focus groups of youth and parents, will develop a multi-year set of audio-CDs to promote positive parenting practices that support young adolescents in establishing healthy patterns of behavior. This parent education intervention will be tested in a field trial with families of 6th graders recruited from multiple schools in New York City. Baseline and annual follow up surveys will be conducted until youth enter high school. Families receiving the intervention will be compared to those assigned to either an attention-controlled print materials condition or a non-attention controlled condition. It is hypothesized that youth whose parents receive the intervention will delay sexual initiation and report fewer sexual risks, and that their parents will report more positive parenting practices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable hiv-infections

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2013

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

7.1 years

First QC Date

August 21, 2009

Last Update Submit

January 30, 2018

Conditions

Keywords

sexual healthadolescent healthparent educationHIV Seronegativitytreatment experienced

Outcome Measures

Primary Outcomes (1)

  • youth risk behaviors

    12 months

Study Arms (3)

health promotion materials

ACTIVE COMPARATOR

Parents receive health promotion booklets

Behavioral: Healthy Futures parent education

attention-controlled parent print materials

ACTIVE COMPARATOR

Booklets on adolescent sexuality and health

Behavioral: Healthy Futures parent education

audio-CD parent education

EXPERIMENTAL

audio-CDs on parenting practices

Behavioral: Healthy Futures parent education

Interventions

Multi-year audio CD parent education

attention-controlled parent print materialsaudio-CD parent educationhealth promotion materials

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Attendance at selected schools
  • th graders and their parents

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Education Development Center

Newton, Massachusetts, 02458, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

August 21, 2009

First Posted

August 24, 2009

Study Start

April 1, 2006

Primary Completion

April 30, 2013

Study Completion

April 30, 2013

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations