Substance AbusePhase 2NCT01143792
Evaluation of Treatments for Homeless Youths
A Phase 2 study testing Community Reinforcement Approach (CRA) + HIV prevention, Case Management + HIV Prevention and Motivational Enhancement Therapy (MET) + HIV prevention in people with Substance Abuse, run by Ohio State University at 1 site in United States.
Trial summary
Youth who leave home for the streets are at significantly more risk for a multitude of problems, yet little research is available to guide treatment intervention efforts with this population. Studies document high rates of substance use, HIV risk, mental health problems, teenage pregnancy and criminality. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Community Reinforcement Approach (CRA) + HIV prevention, Case Management + HIV Prevention and Motivational Enhancement Therapy (MET) + HIV prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth are between the ages of 14-20.
- Youth have plans to remain in the Columbus areas for at least 12 months.
- Youth meets abuse or dependence DSM-IV criteria for Psychoactive Substance Use or Alcohol disorder, as assessed by the computerized diagnostic interview schedule for children (CDISC, Shaffer, 1992).
- Youth agrees to participate in the assessment and treatment intervention.
- Youth meets criteria for homelessness as defined by DHHS.
Who cannot join
- 1. Evidence of unremitted psychosis or other condition which would impair their ability to understand and participate in the intervention or consent for research participation (as determined by CDISC).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Treatments for Homeless Youth: CRA, MET and Case Management
Youth who leave home for the streets are at significantly more risk for a multitude of problems, yet little research is available to guide treatment intervention efforts with this population. Studies document high rates of substance use, HIV risk, mental health problems, teenage pregnancy and criminality. Research to date examining homeless, street living youth has been primarily descriptive; less effort has been directed towards developing and evaluating treatment interventions for this group. The majority of homeless youth do not receive substance abuse treatment, with one study reporting that only 15% of street living youth report ever receiving mental health services. The effectiveness of the Community Reinforcement Approach (CRA) with street living youth was studied in our recently completed Stage 1 trial. The proposed study is a Stage II clinical trial examining outcome of CRA individual therapy as compared to two interventions commonly employed, yet little researched, with this group. All clients will be randomized to one of three theoretically distinct interventions: (1) CRA therapy, (2) Motivational Enhancement Therapy (MET), or (3) Case Management (CM). The relative effectiveness of these interventions will be evaluated at 3, 6, and 12 months post-baseline. The Social Ecology Theory of Development (Bronfenbrenner, 1979) guides our change hypotheses and intervention. Proposed change mechanisms (mediators) for each intervention will be evaluated. Differential treatment response as a function of ethnicity, gender, age, sexual orientation and abuse (moderators) will be investigated to better understand the interventions. The study will also examine how, if at all, treatment engagement, retention and expectations impact youth response to the three treatments. Information gained through this project may help address the gap in our understanding of how best to effectively intervene with a group at high risk for continuing health and psychological problems.
- Conditions
- Substance Abuse
- Being tested
- Community Reinforcement Approach (CRA) + HIV prevention, Case Management + HIV Prevention, Motivational Enhancement Therapy (MET) + HIV prevention
- Keywords
- Substance abuse, Homelessness, HIV risk behavior
- 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.
Community Reinforcement Approach (CRA) + HIV preventionBehavioural
12 sessions of the CRA and 2 sessions of HIV prevention.
Case Management + HIV PreventionBehavioural
12 sessions of case management and 2 sessions of HIV prevention.
Motivational Enhancement Therapy (MET) + HIV preventionBehavioural
2 sessions of MET and 2 sessions of HIV prevention.
| Study group | Role | What they receive |
|---|---|---|
| CRA + HIV prevention | Experimental | Not described Receives: Behavioral: Community Reinforcement Approach (CRA) + HIV prevention |
| Case Management + HIV prevention | Active comparator | Not described Receives: Behavioral: Case Management + HIV Prevention |
| MET + HIV prevention | Active comparator | Not described Receives: Behavioral: Motivational Enhancement Therapy (MET) + HIV prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance Use
Percentage of substance use days in prior three months.
Measured: Three months
Substance Use
Percentage of substance use days in prior three months
Measured: Six months
Substance Use
Percentage of substance use days in prior six months
Measured: Twelve months
Secondary outcomes (6)
HIV Risk
Frequency of condoms use in prior three months.
Measured: Three months
HIV Risk
Frequency of condoms use in prior three months.
Measured: Six months
HIV Risk
Frequency of condoms use in prior six months.
Measured: Twelve months
Depressive Symptoms
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)
Measured: Three months
Depressive Symptoms
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
Measured: Six months
Depressive Symptoms
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startSep 2006
- Primary completionDec 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Natasha Slesnick, Ohio State University
- Investigators
- Natasha Slesnick, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143792
- Sponsor's protocol ID
- 2005B0078
- Other IDs
- R01DA013549
- Status last verified
- Apr 2013
- First submitted
- 11 Jun 2010
- Last updated
- 16 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatments for Homeless Youth: CRA, MET and Case Management
- ClinicalTrials.gov ID
- NCT01143792
- Acronym / sponsor ID
- 2005B0078
- Conditions
- Substance Abuse
- Keywords
- Substance abuse, Homelessness, HIV risk behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Posted 16 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Youth who leave home for the streets are at significantly more risk for a multitude of problems, yet little research is available to guide treatment intervention efforts with this population. Studies document high rates of substance use, HIV risk, mental health problems, teenage pregnancy and criminality. Research to date examining homeless, street living youth has been primarily descriptive; less effort has been directed towards developing and evaluating treatment interventions for this group. The majority of homeless youth do not receive substance abuse treatment, with one study reporting that only 15% of street living youth report ever receiving mental health services. The effectiveness of the Community Reinforcement Approach (CRA) with street living youth was studied in our recently completed Stage 1 trial. The proposed study is a Stage II clinical trial examining outcome of CRA individual therapy as compared to two interventions commonly employed, yet little researched, with this group. All clients will be randomized to one of three theoretically distinct interventions: (1) CRA therapy, (2) Motivational Enhancement Therapy (MET), or (3) Case Management (CM). The relative effectiveness of these interventions will be evaluated at 3, 6, and 12 months post-baseline. The Social Ecology Theory of Development (Bronfenbrenner, 1979) guides our change hypotheses and intervention. Proposed change mechanisms (mediators) for each intervention will be evaluated. Differential treatment response as a function of ethnicity, gender, age, sexual orientation and abuse (moderators) will be investigated to better understand the interventions. The study will also examine how, if at all, treatment engagement, retention and expectations impact youth response to the three treatments. Information gained through this project may help address the gap in our understanding of how best to effectively intervene with a group at high risk for continuing health and psychological problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRA + HIV prevention | Experimental | Behavioral: Community Reinforcement Approach (CRA) + HIV prevention |
| Case Management + HIV prevention | Active comparator | Behavioral: Case Management + HIV Prevention |
| MET + HIV prevention | Active comparator | Behavioral: Motivational Enhancement Therapy (MET) + HIV prevention |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Youth are between the ages of 14-20.
- Youth have plans to remain in the Columbus areas for at least 12 months.
- Youth meets abuse or dependence DSM-IV criteria for Psychoactive Substance Use or Alcohol disorder, as assessed by the computerized diagnostic interview schedule for children (CDISC, Shaffer, 1992).
- Youth agrees to participate in the assessment and treatment intervention.
- Youth meets criteria for homelessness as defined by DHHS.
Key exclusion criteria (1 listed)
- 1. Evidence of unremitted psychosis or other condition which would impair their ability to understand and participate in the intervention or consent for research participation (as determined by CDISC).
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 |
|---|---|---|
| Community Reinforcement Approach (CRA) + HIV prevention12 sessions of the CRA and 2 sessions of HIV prevention. | Behavioural | CRA + HIV prevention |
| Case Management + HIV Prevention12 sessions of case management and 2 sessions of HIV prevention. | Behavioural | Case Management + HIV prevention |
| Motivational Enhancement Therapy (MET) + HIV prevention2 sessions of MET and 2 sessions of HIV prevention. | Behavioural | MET + HIV prevention |
Primary outcome
Substance Use
Time frame: Three months
Percentage of substance use days in prior three months.
Substance Use
Time frame: Six months
Percentage of substance use days in prior three months
Substance Use
Time frame: Twelve months
Percentage of substance use days in prior six months
6 secondary outcomes
HIV Risk
Time frame: Three months
HIV Risk
Time frame: Six months
HIV Risk
Time frame: Twelve months
Depressive Symptoms
Time frame: Three months
Depressive Symptoms
Time frame: Six months
Depressive Symptoms
Time frame: Twelve months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Natasha Slesnick, Ph.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Community Reinforcement Approach (CRA) + HIV prevention, Case Management + HIV Prevention and Motivational Enhancement Therapy (MET) + HIV prevention in people with Substance Abuse, run by Ohio State University at 1 site in United States.
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 5 inclusion and 1 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 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Substance Use (time frame: Three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2013.