HIV InfectionsPhase 1NCT00500487
Therapeutic Schools: Affect Management and HIV Prevention
A Phase 1 study testing Affect Management, HIV Prevention Skills and General Health Promotion in people with HIV Infections, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Adolescents are at risk for HIV because of sexual and drug behavior intiated during this developmental period. Those with psychological distress are less likely than their peers to benefit from frequently used skills-based interventions. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Affect Management, HIV Prevention Skills and General Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jun 2010
- Phase
- Phase 1
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent attending therapeutic school
Who cannot join
- Adolescent is HIV positive
- Adolescent is developmentally delayed
- Adolescent is pregnant
- Adolescent has a history of sexual crime
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Adolescents are at risk for HIV because of sexual and drug behavior intiated during this developmental period. Those with psychological distress are less likely than their peers to benefit from frequently used skills-based interventions. It appears that emotional lability during sexual situations disrupts skills learned. This project will implement and evaluate interventions for adolescents with psychiatric disorders who are in therapeutic school settings. Affect management and skills-based interventions will be compared to a didactic standard of care condition to determine which intervention best reduces risk behavior among adolescents with psychiatric disorders in therapeutic school settings.
- Conditions
- HIV Infections
- Being tested
- Affect Management, HIV Prevention Skills, General Health Promotion
- Keywords
- HIV prevention, HIV seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affect ManagementBehavioural
12-session group intervention including affect management training as well as sexual health skills training.
HIV Prevention SkillsBehavioural
12-session group intervention including sexual health skills training.
General Health PromotionBehavioural
12-session group intervention including health information on a variety of health topics.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Affect Management |
| 2 | Active comparator | Not described Receives: Behavioral: HIV Prevention Skills |
| 3 | Active comparator | Not described Receives: Behavioral: General Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent-reported condom use
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startApr 2003
- Primary completionJun 2010
- Study completionJun 2010
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 HIV InfectionsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Responsible party
- Sponsor
- Investigators
- Larry K Brown, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500487
- Sponsor's protocol ID
- R01MH066641
- Other IDs
- R01MH066641
- Status last verified
- Oct 2009
- First submitted
- 11 Jul 2007
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown LK, Whiteley L, Houck CD, Craker LK, Lowery A, Beausoleil N, Donenberg G. The Role of Affect Management for HIV Risk Reduction for Youth in Alternative Schools. J Am Acad Child Adolesc Psychiatry. 2017 Jun;56(6):524-531. doi: 10.1016/j.jaac.2017.03.010. Epub 2017 Mar 31.
PubMed 28545758
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Schools: Affect Management and HIV Prevention
- ClinicalTrials.gov ID
- NCT00500487
- Acronym / sponsor ID
- R01MH066641
- Conditions
- HIV Infections
- Keywords
- HIV prevention, HIV seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- Apr 2003
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Jul 2007 (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.
Adolescents are at risk for HIV because of sexual and drug behavior intiated during this developmental period. Those with psychological distress are less likely than their peers to benefit from frequently used skills-based interventions. It appears that emotional lability during sexual situations disrupts skills learned. This project will implement and evaluate interventions for adolescents with psychiatric disorders who are in therapeutic school settings. Affect management and skills-based interventions will be compared to a didactic standard of care condition to determine which intervention best reduces risk behavior among adolescents with psychiatric disorders in therapeutic school settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Affect Management |
| 2 | Active comparator | Behavioral: HIV Prevention Skills |
| 3 | Active comparator | Behavioral: General Health Promotion |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent attending therapeutic school
Key exclusion criteria (4 listed)
- Adolescent is HIV positive
- Adolescent is developmentally delayed
- Adolescent is pregnant
- Adolescent has a history of sexual crime
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 |
|---|---|---|
| Affect Management12-session group intervention including affect management training as well as sexual health skills training. | Behavioural | 1 |
| HIV Prevention Skills12-session group intervention including sexual health skills training. | Behavioural | 2 |
| General Health Promotion12-session group intervention including health information on a variety of health topics. | Behavioural | 3 |
Primary outcome
Adolescent-reported condom use
Time frame: 1 year
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 12 Jan 2015.
- Derived from this study: PubMed 28545758Brown LK, Whiteley L, Houck CD, Craker LK, Lowery A, Beausoleil N, Donenberg G. The Role of Affect Management for HIV Risk Reduction for Youth in Alternative Schools. J Am Acad Child Adolesc Psychiatry. 2017 Jun;56(6):524-531. doi: 10.1016/j.jaac.2017.03.010. Epub 2017 Mar 31.
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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.
Larry K Brown, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Affect Management, HIV Prevention Skills and General Health Promotion in people with HIV Infections, run by Rhode Island Hospital 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 1 inclusion and 4 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 12 Jan 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adolescent-reported condom use (time frame: 1 year). 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 NCT00500487, 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 12 Jan 2015.