Risk Reduction Through Family TherapyRRFTNCT00998153
Risk Reduction for Drug Use and Sexual Revictimization
A study testing Risk Reduction through Family Therapy in people with Risk Reduction Through Family Therapy and Usual Care, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually assaulted youth, and 3) psychoeducation strategies… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Risk Reduction Through Family Therapy, Usual Care
- What is being tested?
- Risk Reduction through Family Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2006to 30 Jun 2012
- 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
- memorable sexual assault
Who cannot join
- active psychosis
- active suicidality
Trial locations and contacts
1 site in 1 country.
United States1 site
National Crime Victims Research and Treatment Center
Charleston, South Carolina, 29425
About this study
The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually assaulted youth, and 3) psychoeducation strategies for prevention of risky sexual behaviors and revictimization. The principal purpose of this research proposal is to evaluate the efficacy of RRFT in reducing the risk of drug abuse and other risky behaviors, PTSD, and revictimization among adolescents who have been sexually assaulted. The Research Plan will be conducted based on Stage 1a and Stage 1b from NIDA's Behavioral Therapies Development Program as described in Rounsaville, Carroll, \& Onken (2001). The final phase of the research will involve conducting a pilot randomized controlled trial of RRFT in a sample of adolescents, comparing primary outcome measures of youth receiving RRFT to youth receiving usual care in the community. Participants will be adolescents (12-17 years) who have experienced a sexual assault. Assessment of substance use and other risk behaviors, trauma-related psychopathology, and incidents of revictimization will be collected at pre- and post- treatment, as well as 6-week and 3-month follow-ups. Hierarchical Linear Modeling will be the primary method used to test study hypotheses. Development and evaluation of the proposed intervention will have significant implications for addressing public health problems in adolescent substance abuse and related high risk behaviors.
Read the detailed description
See above summary
- Conditions
- Risk Reduction Through Family Therapy, Usual Care
- Being tested
- Risk Reduction through Family Therapy
- Keywords
- substance use, PTSD, risky behaviors, revictimization
- Medical subject headings
- Substance-Related Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Reduction through Family TherapyBehavioural
Also called RRFT
Component based intervention based on existing empirically supported treatments
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | RRFT Receives: Behavioral: Risk Reduction through Family Therapy |
| 2 | Active comparator | Usual care Receives: Behavioral: Risk Reduction through Family Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow Back and urine screen
Measured: Pre and post-treatment, 3 and 6 month follow-ups
Secondary outcomes (3)
YRBS
Measured: Pre and post-treatment, 3 and 6 month follow-ups
FES
Measured: Pre and post-treatment, 3 and 6 month follow-ups
UCLA PTSD Reaction Index
Measured: Pre, post, and 3 and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study start1 Jul 2006
- Primary completion30 Jun 2011
- Study completion30 Jun 2012
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 Risk Reduction Through Family TherapyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998153
- Sponsor's protocol ID
- K23DA018686
- Other IDs
- K23DA018686
- Acronym
- RRFT
- Status last verified
- May 2018
- First submitted
- 19 Oct 2009
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Danielson CK, McCart MR, Walsh K, de Arellano MA, White D, Resnick HS. Reducing substance use risk and mental health problems among sexually assaulted adolescents: a pilot randomized controlled trial. J Fam Psychol. 2012 Aug;26(4):628-35. doi: 10.1037/a0028862. Epub 2012 Jun 11.
PubMed 22686269
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Reduction for Drug Use and Sexual Revictimization
- ClinicalTrials.gov ID
- NCT00998153
- Acronym / sponsor ID
- RRFT / K23DA018686
- Conditions
- Risk Reduction Through Family Therapy, Usual Care
- Keywords
- substance use, PTSD, risky behaviors, revictimization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2006 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 30 Jun 2012 (actual)
- First posted
- 20 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.
The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually assaulted youth, and 3) psychoeducation strategies for prevention of risky sexual behaviors and revictimization. The principal purpose of this research proposal is to evaluate the efficacy of RRFT in reducing the risk of drug abuse and other risky behaviors, PTSD, and revictimization among adolescents who have been sexually assaulted. The Research Plan will be conducted based on Stage 1a and Stage 1b from NIDA's Behavioral Therapies Development Program as described in Rounsaville, Carroll, \& Onken (2001). The final phase of the research will involve conducting a pilot randomized controlled trial of RRFT in a sample of adolescents, comparing primary outcome measures of youth receiving RRFT to youth receiving usual care in the community. Participants will be adolescents (12-17 years) who have experienced a sexual assault. Assessment of substance use and other risk behaviors, trauma-related psychopathology, and incidents of revictimization will be collected at pre- and post- treatment, as well as 6-week and 3-month follow-ups. Hierarchical Linear Modeling will be the primary method used to test study hypotheses. Development and evaluation of the proposed intervention will have significant implications for addressing public health problems in adolescent substance abuse and related high risk behaviors.
Detailed description
See above summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Risk Reduction through Family TherapyRRFT |
| 2 | Active comparator | Behavioral: Risk Reduction through Family TherapyUsual care |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- memorable sexual assault
Key exclusion criteria (2 listed)
- active psychosis
- active suicidality
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 |
|---|---|---|
| Risk Reduction through Family TherapyAlso: RRFTComponent based intervention based on existing empirically supported treatments | Behavioural | 1, 2 |
Primary outcome
Time Line Follow Back and urine screen
Time frame: Pre and post-treatment, 3 and 6 month follow-ups
3 secondary outcomes
YRBS
Time frame: Pre and post-treatment, 3 and 6 month follow-ups
FES
Time frame: Pre and post-treatment, 3 and 6 month follow-ups
UCLA PTSD Reaction Index
Time frame: Pre, post, and 3 and 6 month follow-up
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 18 Jun 2018.
- Derived from this study: PubMed 22686269Danielson CK, McCart MR, Walsh K, de Arellano MA, White D, Resnick HS. Reducing substance use risk and mental health problems among sexually assaulted adolescents: a pilot randomized controlled trial. J Fam Psychol. 2012 Aug;26(4):628-35. doi: 10.1037/a0028862. Epub 2012 Jun 11.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Reduction through Family Therapy in people with Risk Reduction Through Family Therapy and Usual Care, run by Medical University of South Carolina 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 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 18 Jun 2018. 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.
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?
Time Line Follow Back and urine screen (time frame: Pre and post-treatment, 3 and 6 month follow-ups). 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 NCT00998153, 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 18 Jun 2018.