Family RelationsSTRIVENCT00996541
Support To Reunite Involve and Value Each Other
A study testing STRIVE family intervention in people with Family Relations and Runaway Behavior, run by University of California, Los Angeles.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Family Relations, Runaway Behavior, Risky Sexual Behavior
- What is being tested?
- STRIVE family intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Diverting Homeless Youth From Chronic Homelessness and Risk for HIV
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.
- Being tested
- STRIVE family intervention
- Keywords
- Runaway youth, Homeless youth, Family intervention, Family functioning, HIV risk behavior, HIV Seronegativity
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIVE family interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: STRIVE family intervention |
| Control | Placebo comparator | Not described Receives: Behavioral: STRIVE family intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved residential stability
Measured: Assessed up to 24 months
Secondary outcomes (1)
Reduced HIV risk behavior
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startSep 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family RelationsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996541
- Sponsor's protocol ID
- 5R01MH070322-05
- Other IDs
- 5R01MH070322-05
- Acronym
- STRIVE
- Status last verified
- May 2023
- First submitted
- 15 Oct 2009
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22443839
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diverting Homeless Youth From Chronic Homelessness and Risk for HIV
- ClinicalTrials.gov ID
- NCT00996541
- Acronym / sponsor ID
- STRIVE / 5R01MH070322-05
- Keywords
- Runaway youth, Homeless youth, Family intervention, Family functioning, HIV risk behavior, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: STRIVE family intervention |
| Control | Placebo comparator | Behavioral: STRIVE family intervention |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRIVE family interventionAdolescent 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. | Behavioural | Control, Intervention |
Primary outcome
Improved residential stability
Time frame: Assessed up to 24 months
1 secondary outcome
Reduced HIV risk behavior
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Results publication: PubMed 22443839Milburn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing STRIVE family intervention in people with Family Relations and Runaway Behavior, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved residential stability (time frame: Assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00996541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.