PTSDRRFTNCT01751035
Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD
A study testing Risk Reduction through Family Therapy and Treatment as Usual in people with PTSD and Alcohol Use Disorders, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Adolescents receiving RRFT and their caregivers will report significantly fewer substance use problems (quantity of use, frequency of use, and abuse symptoms) during treatment and follow-up than control adolescents who receive Treatment as Usual (TAU). Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- PTSD, Alcohol Use Disorders, Substance Use Disorders
- What is being tested?
- Risk Reduction through Family Therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2012to 12 Jul 2018
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1) 13-18 years old;
- 2) Presenting to LCC/HH for evaluation or treatment;
- 3) Report having experienced IPV in their lifetime, including: CSA, defined as forced or unwanted: (a) vaginal or anal penetration by an object, finger, or penis; (b) oral sex; (c) touching of the respondent's breasts or genitalia; or (d) respondents' touching of another person's genitalia; CPA, defined as having been (a) attacked or threatened with a gun, knife, or some other weapon; (b) attacked by another person with perceived intent to kill or seriously injure; (c) beaten and injured (i.e., "hurt pretty badly") by another person; (d) spanked so forcefully that it resulted in sustained welts or bruises or required medical care; or (e) cut, burned, or tied up by a caregiver as a punitive consequence; Exposure to Domestic Violence; and being victim of or bearing witness to Community Violence.
- 4) Have a memory of the incident(s);
- 5) Five or more DSM-IV PTSD symptoms;
- 6) Substance use, defined as alcohol or illicit drug use in the past 90 days per self-report and/or urine drug screen or breathalyzer.
Who cannot join
- 1) Previously identified as having a Pervasive Developmental Disability or Moderate to Severe Mental Retardation;
- 2) Actively suicidal or homicidal;
- 3) Reports active psychotic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Adolescents receiving RRFT and their caregivers will report significantly fewer substance use problems (quantity of use, frequency of use, and abuse symptoms) during treatment and follow-up than control adolescents who receive Treatment as Usual (TAU). Adolescents receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk and protective factors for substance use and abuse at the individual level (e.g., coping) and at each level of an adolescent's ecology (e.g., increased number of positive family activities, reduced family conflict, reduced number of peers who use drugs, improved school attendance, increased involvement in pro-social community activities) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will experience less PTSD symptoms (per youth and caregiver reports) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during treatment and follow-up than control adolescents who receive TAU. Changes during treatment in family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth relationship) and parenting practices (monitoring) will mediate changes in substance use. Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.
Read the detailed description
See above.
- Conditions
- PTSD, Alcohol Use Disorders, Substance Use Disorders
- Being tested
- Risk Reduction through Family Therapy, Treatment as Usual
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism, Substance-Related Disorders
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
RRFT is an integrative, ecologically-based approach to risk reduction and treatment. A Stage 1a feasibility trial and a Stage 1b pilot randomized controlled trial (RCT) evaluating RRFT have been completed. This Stage 1 work has resulted in a treatment manual, a clinician training protocol, and a quality assurance system. Preliminary findings from these studies are promising, indicating that RRFT can be readily learned and implemented with fidelity, and that it can lead to improvements in drug use and drug use-related risk and protective factors, PTSD symptoms, and risky sexual behaviors.
Treatment as UsualBehavioural
Also called TAU
Participants assigned to the TAU condition will receive the standard treatment that a CSA victim would typically receive at community advocacy centers. In addition to treatment that is typically offered at the CACs, this will include a referral for substance abuse evaluation and may include referrals to other agencies in the community. TAU has been utilized as a comparison condition for several behavioral treatment evaluations involving adolescent substance abuse.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Placebo comparator | Treatment as Usual (TAU) will be defined as it already exists within the community child advocacy centers. This could include individual and/or group therapy using a variety of treatment models. Receives: Behavioral: Treatment as Usual |
| RRFT | Experimental | RRFT is an acronym for an experimental intervention named Risk Reduction through Family Therapy. Please see intervention description for more detail about the model. Receives: Behavioral: Risk Reduction through Family Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in substance use problems (initiation/continuation, quantity, and abuse symptoms)
Measured: 18 months
Secondary outcomes (2)
change in PTSD severity and symptoms
Measured: 18 months
change in risky sexual behaviors
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study start1 Nov 2012
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
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 PTSDStudies 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
- Double blind
- Who is masked
- Investigator, 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
- Investigators
- Carla K Danielson, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751035
- Sponsor's protocol ID
- Pro00009042
- Other IDs
- R01DA031285-01
- Acronym
- RRFT
- Status last verified
- Aug 2018
- First submitted
- 15 Nov 2012
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Danielson CK, Adams Z, McCart MR, Chapman JE, Sheidow AJ, Walker J, Smalling A, de Arellano MA. Safety and Efficacy of Exposure-Based Risk Reduction Through Family Therapy for Co-occurring Substance Use Problems and Posttraumatic Stress Disorder Symptoms Among Adolescents: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):574-586. doi: 10.1001/jamapsychiatry.2019.4803.
PubMed 32022827
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD
- ClinicalTrials.gov ID
- NCT01751035
- Acronym / sponsor ID
- RRFT / Pro00009042
- Conditions
- PTSD, Alcohol Use Disorders, Substance Use Disorders
- 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 Nov 2012 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 17 Dec 2012 (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 receiving RRFT and their caregivers will report significantly fewer substance use problems (quantity of use, frequency of use, and abuse symptoms) during treatment and follow-up than control adolescents who receive Treatment as Usual (TAU). Adolescents receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk and protective factors for substance use and abuse at the individual level (e.g., coping) and at each level of an adolescent's ecology (e.g., increased number of positive family activities, reduced family conflict, reduced number of peers who use drugs, improved school attendance, increased involvement in pro-social community activities) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will experience less PTSD symptoms (per youth and caregiver reports) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during treatment and follow-up than control adolescents who receive TAU. Changes during treatment in family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth relationship) and parenting practices (monitoring) will mediate changes in substance use. Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.
Detailed description
See above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Placebo comparator | Behavioral: Treatment as UsualTreatment as Usual (TAU) will be defined as it already exists within the community child advocacy centers. This could include individual and/or group therapy using a variety of treatment models. |
| RRFT | Experimental | Behavioral: Risk Reduction through Family TherapyRRFT is an acronym for an experimental intervention named Risk Reduction through Family Therapy. Please see intervention description for more detail about the model. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 1) 13-18 years old;
- 2) Presenting to LCC/HH for evaluation or treatment;
- 3) Report having experienced IPV in their lifetime, including: CSA, defined as forced or unwanted: (a) vaginal or anal penetration by an object, finger, or penis; (b) oral sex; (c) touching of the respondent's breasts or genitalia; or (d) respondents' touching of another person's genitalia; CPA, defined as having been (a) attacked or threatened with a gun, knife, or some other weapon; (b) attacked by another person with perceived intent to kill or seriously injure; (c) beaten and injured (i.e., "hurt pretty badly") by another person; (d) spanked so forcefully that it resulted in sustained welts or bruises or required medical care; or (e) cut, burned, or tied up by a caregiver as a punitive consequence; Exposure to Domestic Violence; and being victim of or bearing witness to Community Violence.
- 4) Have a memory of the incident(s);
- 5) Five or more DSM-IV PTSD symptoms;
Key exclusion criteria (3 listed)
- 1) Previously identified as having a Pervasive Developmental Disability or Moderate to Severe Mental Retardation;
- 2) Actively suicidal or homicidal;
- 3) Reports active psychotic disorder
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: RRFTRRFT is an integrative, ecologically-based approach to risk reduction and treatment. A Stage 1a feasibility trial and a Stage 1b pilot randomized controlled trial (RCT) evaluating RRFT have been completed. This Stage 1 work has resulted in a treatment manual, a clinician training protocol, and a quality assurance system. Preliminary findings from these studies are promising, indicating that RRFT can be readily learned and implemented with fidelity, and that it can lead to improvements in drug use and drug use-related risk and protective factors, PTSD symptoms, and risky sexual behaviors. | Behavioural | RRFT |
| Treatment as UsualAlso: TAUParticipants assigned to the TAU condition will receive the standard treatment that a CSA victim would typically receive at community advocacy centers. In addition to treatment that is typically offered at the CACs, this will include a referral for substance abuse evaluation and may include referrals to other agencies in the community. TAU has been utilized as a comparison condition for several behavioral treatment evaluations involving adolescent substance abuse. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
change in substance use problems (initiation/continuation, quantity, and abuse symptoms)
Time frame: 18 months
2 secondary outcomes
change in PTSD severity and symptoms
Time frame: 18 months
change in risky sexual behaviors
Time frame: 18 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 3 Aug 2018.
- Derived from this study: PubMed 32022827Danielson CK, Adams Z, McCart MR, Chapman JE, Sheidow AJ, Walker J, Smalling A, de Arellano MA. Safety and Efficacy of Exposure-Based Risk Reduction Through Family Therapy for Co-occurring Substance Use Problems and Posttraumatic Stress Disorder Symptoms Among Adolescents: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):574-586. doi: 10.1001/jamapsychiatry.2019.4803.
Related trials for PTSD
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Carla K Danielson, PhD principal investigator
Medical University of South Carolina
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 and Treatment as Usual in people with PTSD and Alcohol Use Disorders, 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 6 inclusion and 3 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 3 Aug 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. 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?
change in substance use problems (initiation/continuation, quantity, and abuse symptoms) (time frame: 18 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 NCT01751035, 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 3 Aug 2018.