NCT00996541

Brief Summary

Runaway and homeless youth are at risk for HIV based upon their rates of substance use, particularly injection drug use, unprotected sexual intercourse, multiple partners, and sexually transmitted diseases. Risk increases as the time away from home increases. STRIVE is a family intervention aimed at increasing residential stability, decreasing runaway episodes, and decreasing HIV risk. Families are randomly assigned to a cognitive-behavioral skills-building intervention consisting of five weekly sessions delivered at family homes, or are assigned to standard care. Sessions are aimed at increasing problem solving, role clarity, and positive interactions. It is hypothesized that the intervention will result in improved family dynamics, less runaway behavior, and less risky behavior.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

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

September 1, 2004

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

4.8 years

First QC Date

October 15, 2009

Last Update Submit

May 11, 2023

Conditions

Keywords

Runaway youthHomeless youthFamily interventionFamily functioningHIV risk behaviorHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Improved residential stability

    Assessed up to 24 months

Secondary Outcomes (1)

  • Reduced HIV risk behavior

    Up to 24 months

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: STRIVE family intervention

Control

PLACEBO COMPARATOR
Behavioral: STRIVE family intervention

Interventions

Adolescent and parent attend a 5-session family-oriented cognitive-behavioral intervention aimed at giving runaway youths and their parents the tools to effectively deal with conflict.

ControlIntervention

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Youth: Age 12-17 who ran away or were told to leave home within the past 6 months. Must provide assent and parent/guardian must provide informed consent.
  • Parent/guardian: must be parent/guardian of participating youth who ran away. Must provide informed consent.

You may not qualify if:

  • Youth: total time away from home exceeds 12 months. Obvious cognitive impairment. Sexual or physical abuse from the parent/guardian. Lack of assent/consent.
  • Parent/guardian: obvious cognitive impairment. Lack of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Milburn NG, Iribarren FJ, Rice E, Lightfoot M, Solorio R, Rotheram-Borus MJ, Desmond K, Lee A, Alexander K, Maresca K, Eastmen K, Arnold EM, Duan N. A family intervention to reduce sexual risk behavior, substance use, and delinquency among newly homeless youth. J Adolesc Health. 2012 Apr;50(4):358-64. doi: 10.1016/j.jadohealth.2011.08.009. Epub 2011 Oct 26.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

September 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 15, 2023

Record last verified: 2023-05