Dating ViolencePhase 1NCT01326195
Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions
A Phase 1 study testing Cognitive-Behavioral Dating Violence and HIV Prevention Group and Psycho-educational Dating Violence and HIV prevention group in people with Dating Violence and HIV Infections, run by Rhode Island Hospital at 1 site in United States.
Trial summary
This project is designed to develop and test a group-based preventive intervention to reduce dating violence and sexual risk behavior among adolescent females with prior dating violence exposure. Read more about this study
- Who is it for?
- Ages 15 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dating Violence, HIV Infections
- What is being tested?
- Cognitive-Behavioral Dating Violence and HIV Prevention Group and Psycho-educational Dating Violence and HIV prevention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Feb 2014
- 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 15 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescent must be English-speaking
- Adolescent must have a lifetime history of physical dating violence perpetration or victimization
Who cannot join
- Current enrollment in an intervention for dating violence or HIV prevention
Trial locations and contacts
1 site in 1 country.
Christie J. Rizzo, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Christie Rizzo, PhD, 401-793-8064
Christie J. Rizzo, Ph.D.
About this study
This project is designed to develop and test a group-based preventive intervention to reduce dating violence and sexual risk behavior among adolescent females with prior dating violence exposure.
Read the detailed description
A growing body of research reveals that dating violence (DV) plays a significant role in adolescent girls' HIV risk. Dating violence has been associated with less condom use, younger age at first intercourse, having multiple sex partners and alcohol use prior to sexual encounters. Thus, prevention strategies that address dating violence and HIV risk may hold promise for reducing sexual risk behavior among a particularly at-risk population. In this study, a cognitive-behaviorally based intervention named "Skills to Manage Aggression in Relationships for Teens" (Date S.M.A.R.T.) is being developed and compared to a psychoeducational program for dating violence and HIV prevention. The program is being implemented with a sample of underserved youth, as economic disadvantage and minority status have been found to be related to increased rates of adolescent dating violence. A primary focus of the intervention is to address mental health problems (i.e. psychological distress and behavioral dysregulation) that underlie the development and maintenance of both dating violence and sexual risk behavior among adolescent girls.
- Conditions
- Dating Violence, HIV Infections
- Being tested
- Cognitive-Behavioral Dating Violence and HIV Prevention Group, Psycho-educational Dating Violence and HIV prevention group
- Keywords
- HIV Prevention, Dating Violence, Females, Romantic relationships, Adolescents, Sexuality, Underserved youth
- Medical subject headings
- HIV Infections, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Dating Violence and HIV Prevention GroupBehavioural
Also called Date SMART
Six, two-hour weekly sessions and one 2-hour booster session 6 weeks later with adolescent females
Psycho-educational Dating Violence and HIV prevention groupBehavioural
Knowledge based intervention matched for time and attention to skills arm
| Study group | Role | What they receive |
|---|---|---|
| Skills | Experimental | Cognitive-Behavioral Dating Violence and HIV Prevention Group Receives: Behavioral: Cognitive-Behavioral Dating Violence and HIV Prevention Group |
| Health Promotion | Active comparator | Psycho-educational Dating Violence and HIV Prevention group Receives: Behavioral: Psycho-educational Dating Violence and HIV prevention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number (#) of unprotected sex acts
Measured: Baseline, 3 months, 6 months, 9 months
Secondary outcomes (1)
Change in number of acts of dating violence perpetration and victimization
Measured: Baseline, 3 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMay 2009
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
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 Dating ViolenceStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Christie J. Rizzo, Ph.D., Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326195
- Sponsor's protocol ID
- K23MH086328
- Status last verified
- Mar 2011
- First submitted
- 28 Mar 2011
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rizzo CJ, Joppa M, Barker D, Collibee C, Zlotnick C, Brown LK. Project Date SMART: a Dating Violence (DV) and Sexual Risk Prevention Program for Adolescent Girls with Prior DV Exposure. Prev Sci. 2018 May;19(4):416-426. doi: 10.1007/s11121-018-0871-z.
PubMed 29352400
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions
- ClinicalTrials.gov ID
- NCT01326195
- Acronym / sponsor ID
- K23MH086328
- Conditions
- Dating Violence, HIV Infections
- Keywords
- HIV Prevention, Dating Violence, Females, Romantic relationships, Adolescents, Sexuality, Underserved youth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 30 Mar 2011 (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.
This project is designed to develop and test a group-based preventive intervention to reduce dating violence and sexual risk behavior among adolescent females with prior dating violence exposure.
Detailed description
A growing body of research reveals that dating violence (DV) plays a significant role in adolescent girls' HIV risk. Dating violence has been associated with less condom use, younger age at first intercourse, having multiple sex partners and alcohol use prior to sexual encounters. Thus, prevention strategies that address dating violence and HIV risk may hold promise for reducing sexual risk behavior among a particularly at-risk population. In this study, a cognitive-behaviorally based intervention named "Skills to Manage Aggression in Relationships for Teens" (Date S.M.A.R.T.) is being developed and compared to a psychoeducational program for dating violence and HIV prevention. The program is being implemented with a sample of underserved youth, as economic disadvantage and minority status have been found to be related to increased rates of adolescent dating violence. A primary focus of the intervention is to address mental health problems (i.e. psychological distress and behavioral dysregulation) that underlie the development and maintenance of both dating violence and sexual risk behavior among adolescent girls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skills | Experimental | Behavioral: Cognitive-Behavioral Dating Violence and HIV Prevention GroupCognitive-Behavioral Dating Violence and HIV Prevention Group |
| Health Promotion | Active comparator | Behavioral: Psycho-educational Dating Violence and HIV prevention groupPsycho-educational Dating Violence and HIV Prevention group |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Adolescent must be English-speaking
- Adolescent must have a lifetime history of physical dating violence perpetration or victimization
Key exclusion criteria (1 listed)
- Current enrollment in an intervention for dating violence or HIV prevention
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 |
|---|---|---|
| Cognitive-Behavioral Dating Violence and HIV Prevention GroupAlso: Date SMARTSix, two-hour weekly sessions and one 2-hour booster session 6 weeks later with adolescent females | Behavioural | Skills |
| Psycho-educational Dating Violence and HIV prevention groupKnowledge based intervention matched for time and attention to skills arm | Behavioural | Health Promotion |
Primary outcome
Change in number (#) of unprotected sex acts
Time frame: Baseline, 3 months, 6 months, 9 months
1 secondary outcome
Change in number of acts of dating violence perpetration and victimization
Time frame: Baseline, 3 months, 6 months, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2011.
- Derived from this study: PubMed 29352400Rizzo CJ, Joppa M, Barker D, Collibee C, Zlotnick C, Brown LK. Project Date SMART: a Dating Violence (DV) and Sexual Risk Prevention Program for Adolescent Girls with Prior DV Exposure. Prev Sci. 2018 May;19(4):416-426. doi: 10.1007/s11121-018-0871-z.
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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.
Christie J. Rizzo, Ph.D. contact
Christie J. Rizzo, Ph.D. 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 Cognitive-Behavioral Dating Violence and HIV Prevention Group and Psycho-educational Dating Violence and HIV prevention group in people with Dating Violence and 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 2 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: status not confirmed, as of the sponsor's last update on 30 Mar 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christie J. Rizzo, Ph.D. (401-793-8064), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number (#) of unprotected sex acts (time frame: Baseline, 3 months, 6 months, 9 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 NCT01326195, 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 30 Mar 2011.