Substance Use DisordersSTARNCT05384223
Evaluation of RRFT for Co-occurring SUD and PTSD Among Teens
A study testing RRFT (Risk Reduction through Family Therapy) and ENCOMPASS (Integrated Treatment for Adolescents and Young Adults) in people with Substance Use Disorders and PTSD, run by Medical University of South Carolina at 2 sites in United States.
Trial summary
Psychosocial traumatic events during childhood, serve as strong and consistent predictors of substance use problems (SUP) during adolescence and adulthood.PTSD that extends from such trauma often co-occurs with SUP. Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Substance Use Disorders, PTSD
- What is being tested?
- RRFT (Risk Reduction through Family Therapy) and ENCOMPASS (Integrated Treatment for Adolescents and Young Adults)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2022to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 13-19 years (adolescents);
- Experienced lifetime DSM-V PTSD Criteria A-defined potentially traumatic event, such as interpersonal violence, with memory of incident(s), such as child sexual abuse (forced or unwanted vaginal or anal penetration by an object, finger, or penis; oral sex; touching of the respondent's breasts or genitalia; or respondents' touching of another person's genitalia); child physical abuse (nonaccidental physical injury to the child or any action that results in a physical impairment of the child), witnessed domestic violence (exposure to conduct by a household member against another household member that involves attempted or completed assault or murder); witnessed community violence; dating violence; as well as disasters, accidents, etc.;
- Five or more current DSM-V PTSD symptoms as assessed on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)/UCLA PTSD Index;
- Substance use, defined as alcohol or non-tobacco drug use, in the past 28 days prior to study screening per self-report. If in a restrictive setting for the 28 days prior to study screening, substance use will be anchored to use prior to entering restrictive setting;
- A current (past year) non-nicotine substance use disorder (SUD) as assessed on the K-SADS;
- English-speaking.
Who cannot join
- Presence of Pervasive Developmental Disability or Moderate/Severe Mental Retardation or other cognitive limitation that would preclude meaningful engagement in RRFT or cognitive-behavioral therapy
- Actively suicidal/homicidal;
- Active psychosis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CU Medicine Psychiatry - Outpatient Clinic
Aurora, Colorado, 80045
ARTS - Synergy Outpatient Services
Denver, Colorado, 80236
About this study
Official title: Evaluation of Clinical Effectiveness, Cost, and Implementation Factors to Optimize Scalability of Treatment for Co-occurring SUD and PTSD Among Teens
Psychosocial traumatic events during childhood, serve as strong and consistent predictors of substance use problems (SUP) during adolescence and adulthood.PTSD that extends from such trauma often co-occurs with SUP. Despite this well-established link, standard care for adolescents with co-occurring SUP and PTSD for the last several decades has been to treat these problems separately. This compartmentalized approach to treatment creates a burden on teens and families, raises unique challenges to clinicians in both mental health and addiction domains, and may contribute to high rates of SUP relapse among adolescents with co-occurring PTSD. To address this problem, our team recently completed a rigorous National Institute on Drug Abuse (NIDA)-funded randomized controlled trial (RCT) supporting the efficacy of an integrative, exposure-based treatment we developed, Risk Reduction through Family Therapy (RRFT), in greater long term reductions in SUP, as well as PTSD avoidance and hyperarousal symptoms, in comparison to standard treatment in a large teen sample. The proposed RCT, with an effectiveness-implementation Hybrid Type I design, substantially builds on that prior research by proposing to 1) evaluate whether RRFT's clinical effectiveness for reducing SUP and PTSD can be extended to youth in outpatient substance use treatment settings-where youth are presenting for SUP treatment and where clinicians often have less experience treating PTSD (Aim 1); 2)evaluate the cost-effectiveness of RRFT and to explore inner context variables (e.g., perceived treatment acceptability, attitudes, and satisfaction among the participating adolescents, caregivers, agency leaders, and therapists and barriers to and facilitators of implementation) that might affect RRFT implementation in diverse practice settings(Aim 2). The proposed effectiveness-implementation trial will recruit adolescents (13-18 years) with a history of psychosocial trauma presenting with SUP and PTSD symptoms for outpatient substance use disorder treatment at sites in Denver, Colorado. Participants will be randomized to RRFT or Treatment as Usual. A multi-method, multi-respondent approach will track clinical outcomes(SUP, PTSD, and putative targets of treatment, such as emotional suppression)at 3, 6, and 12 months post-baseline.
- Conditions
- Substance Use Disorders, PTSD
- Being tested
- RRFT (Risk Reduction through Family Therapy), ENCOMPASS (Integrated Treatment for Adolescents and Young Adults)
- Keywords
- Treatment, Adolescent Substance Use, PTSD
- 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.
RRFT (Risk Reduction through Family Therapy)Behavioural
RRFT is an adaptation and integration of existing empirically-supported interventions with similar theoretical rationales targeting similar populations, particularly Multisystemic Therapy principles (MST)for adolescent SUP and Trauma Focused-Cognitive Behavioral Therapy (TF-CBT) components for PTSD in youth. RRFT consists of seven primary components: Psychoeducation and Engagement, Coping, Family Communication, Substance Use, PTSD, Healthy Dating and Sexual Decision-Making, and Revictimization Risk Reduction.
ENCOMPASS (Integrated Treatment for Adolescents and Young Adults)Behavioural
Encompass is currently a research to practice treatment for adolescents with co-occurring substance use disorders and mental health problems and is used as the standard treatment in the target study settings.
| Study group | Role | What they receive |
|---|---|---|
| RRFT (Risk Reduction through Family Therapy) | Experimental | Not described Receives: Behavioral: RRFT (Risk Reduction through Family Therapy) |
| Treatment as Usual (TAU): Encompass | Active comparator | Not described Receives: Behavioral: ENCOMPASS (Integrated Treatment for Adolescents and Young Adults) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Follow Back (TFLB) - Change from baseline in # days non-tobacco substance used in past 28 days @ 3,6, and 12 months.
The Timeline Follow Back (TLFB) is a validated, subjective measure that uses a calendar for people to provide estimates of substance use (drugs/alcohol) on a daily basis, retrospectively. Key dates and calendars are used to aid in memory recall. The measure is beneficial in both clinical and research environments. Over time, the TLFB looks for a decrease in substance use. Higher numbers of substance use are indicative of greater substance use.
Measured: Collected at baseline, 3, 6, & 12 months
UCLA PTSD Index DSM V - Change from baseline in UCLA PTSD total score @ 3,6, and 12 months
The University of California, Los Angeles (UCLA) Post Traumatic Stress Disorder Index Diagnostic and Statistical Manuals 4th ed (DSM-IV; UCLA PTSD Index DSM-IV) is a validated, subjective measure that consists of 23 yes or no questions regarding the occurrence of different traumas or losses that may happen during a child's life. Each question is followed up with details of the trauma that occurred and more extensive questioning for the trauma experienced that is still most bothersome in the present day. These follow-up questions gauge symptoms of PTSD on a five-point Likert scale that ranges from "none" (score of 0, no days has this symptom occurred in the last month) to "most" (score of 4, symptom occurred almost every day in the past month). The most traumatic experience is also followed by several yes/no questions that gauge distress and functional impairment. Higher scores are indicative of higher rates of PTSD symptoms.
Measured: Collected at baseline, 3, 6, & 12 months
Secondary outcomes (6)
Urine Drug Screen (UDS) - Between group comparison -total # negative UDS /total # collected at baseline, 3, 6, & 12 months
Participants will complete urine drug screens that will be at least 6 panel including cocaine, THC (tetrahydrocannabinol-marijuana), opiates, amphetamines, methamphetamines, and benzodiazepines
Measured: Collected at baseline, 3, 6, & 12 months
Timeline Follow Back (TFLB) - total # of days/28 day of cannabis use, alcohol use, and other non-nicotine substance use (excluding cannabis, alcohol).
The Timeline Follow Back (TLFB) is a validated, subjective measure that uses a calendar for people to provide estimates of substance use (drugs/alcohol) on a daily basis, retrospectively. Key dates and calendars are used to aid in memory recall. The measure is beneficial in both clinical and research environments. Over time, the TLFB looks for a decrease in substance use. Higher numbers of substance use are indicative of greater substance use.
Measured: Collected at baseline, 3, 6, & 12 months
Response to Stress Questionnaire (RSQ) - Change from baseline in Adolescent/Child's Self-Report Responses to Family Stressors (subscale score items a-l)
The RSQ measures coping and involuntary stress responses. Higher scores indicate higher stress.
Measured: Change from baseline @ 3,6, and 12 months
Alabama Parenting Questionnaire (APQ) - positive parenting subscale, inconsistent discipline subscale, and supervision/monitoring subscale.
The Alabama Parenting Questionnaire (APQ) is a validated measure consisting of questions that look into family interactions and, more specifically, interactions between youth and caregiver. The scale is scored on a five-point Likert scale that ranges from "never" (score of 1) to "always" (score of 5) when looking at how often certain behaviors occur within the home. High scores on the positive parenting subscale and low scores on the poor monitoring/supervision, inconsistent discipline, and corporal punishment subscales are indicative of positive parenting.
Measured: Collected at baseline, 3, 6, & 12 months
Difficulties in Emotion Regulation Scale (DERS) - Change from baseline in total score @ 3, 6, & 12 mo f/u
The Difficulties in Emotion Regulation Scale (DERS) is an instrument measuring emotion regulation problems. is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never") to 5 ("almost always"). Higher scores indicate more difficulty in emotion regulation.
Measured: Change from baseline in total score @ 3, 6, & 12 month follow-up
Timeline Follow Back (TLFB) - Average quantity of specific substance used on days of use/28 days
The Timeline Follow Back (TLFB) is a validated, subjective measure that uses a calendar for people to provide estimates of substance use (drugs/alcohol) on a daily basis, retrospectively. Key dates and calendars are used to aid in memory recall. The measure is beneficial in both clinical and research environments. Over time, the TLFB looks for a decrease in substance use. Higher numbers of substance use are indicative of greater substance use.
Measured: Collected at baseline, 3, 6, & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start15 Oct 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies 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
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Indiana University, Oregon Social Learning Center
- Responsible party
- Principal investigator, Carla Kmett Danielson, Medical University of South Carolina
- Investigators
- Carla Kmett Danielson, PhD, Principal investigator, Medical University of South CarolinaPaula Riggs, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384223
- Sponsor's protocol ID
- Pro00113543
- Acronym
- STAR
- Status last verified
- Apr 2026
- First submitted
- 17 May 2022
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Effectiveness, Cost, and Implementation Factors to Optimize Scalability of Treatment for Co-occurring SUD and PTSD Among Teens
- ClinicalTrials.gov ID
- NCT05384223
- Acronym / sponsor ID
- STAR / Pro00113543
- Conditions
- Substance Use Disorders, PTSD
- Keywords
- Treatment, Adolescent Substance Use, PTSD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Indiana University, Oregon Social Learning Center
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 May 2022 (actual)
- 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.
Psychosocial traumatic events during childhood, serve as strong and consistent predictors of substance use problems (SUP) during adolescence and adulthood.PTSD that extends from such trauma often co-occurs with SUP. Despite this well-established link, standard care for adolescents with co-occurring SUP and PTSD for the last several decades has been to treat these problems separately. This compartmentalized approach to treatment creates a burden on teens and families, raises unique challenges to clinicians in both mental health and addiction domains, and may contribute to high rates of SUP relapse among adolescents with co-occurring PTSD. To address this problem, our team recently completed a rigorous National Institute on Drug Abuse (NIDA)-funded randomized controlled trial (RCT) supporting the efficacy of an integrative, exposure-based treatment we developed, Risk Reduction through Family Therapy (RRFT), in greater long term reductions in SUP, as well as PTSD avoidance and hyperarousal symptoms, in comparison to standard treatment in a large teen sample. The proposed RCT, with an effectiveness-implementation Hybrid Type I design, substantially builds on that prior research by proposing to 1) evaluate whether RRFT's clinical effectiveness for reducing SUP and PTSD can be extended to youth in outpatient substance use treatment settings-where youth are presenting for SUP treatment and where clinicians often have less experience treating PTSD (Aim 1); 2)evaluate the cost-effectiveness of RRFT and to explore inner context variables (e.g., perceived treatment acceptability, attitudes, and satisfaction among the participating adolescents, caregivers, agency leaders, and therapists and barriers to and facilitators of implementation) that might affect RRFT implementation in diverse practice settings(Aim 2). The proposed effectiveness-implementation trial will recruit adolescents (13-18 years) with a history of psychosocial trauma presenting with SUP and PTSD symptoms for outpatient substance use disorder treatment at sites in Denver, Colorado. Participants will be randomized to RRFT or Treatment as Usual. A multi-method, multi-respondent approach will track clinical outcomes(SUP, PTSD, and putative targets of treatment, such as emotional suppression)at 3, 6, and 12 months post-baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RRFT (Risk Reduction through Family Therapy) | Experimental | Behavioral: RRFT (Risk Reduction through Family Therapy) |
| Treatment as Usual (TAU): Encompass | Active comparator | Behavioral: ENCOMPASS (Integrated Treatment for Adolescents and Young Adults) |
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 13-19 years (adolescents);
- Experienced lifetime DSM-V PTSD Criteria A-defined potentially traumatic event, such as interpersonal violence, with memory of incident(s), such as child sexual abuse (forced or unwanted vaginal or anal penetration by an object, finger, or penis; oral sex; touching of the respondent's breasts or genitalia; or respondents' touching of another person's genitalia); child physical abuse (nonaccidental physical injury to the child or any action that results in a physical impairment of the child), witnessed domestic violence (exposure to conduct by a household member against another household member that involves attempted or completed assault or murder); witnessed community violence; dating violence; as well as disasters, accidents, etc.;
- Five or more current DSM-V PTSD symptoms as assessed on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)/UCLA PTSD Index;
- Substance use, defined as alcohol or non-tobacco drug use, in the past 28 days prior to study screening per self-report. If in a restrictive setting for the 28 days prior to study screening, substance use will be anchored to use prior to entering restrictive setting;
- A current (past year) non-nicotine substance use disorder (SUD) as assessed on the K-SADS;
Key exclusion criteria (3 listed)
- Presence of Pervasive Developmental Disability or Moderate/Severe Mental Retardation or other cognitive limitation that would preclude meaningful engagement in RRFT or cognitive-behavioral therapy
- Actively suicidal/homicidal;
- Active psychosis.
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 |
|---|---|---|
| RRFT (Risk Reduction through Family Therapy)RRFT is an adaptation and integration of existing empirically-supported interventions with similar theoretical rationales targeting similar populations, particularly Multisystemic Therapy principles (MST)for adolescent SUP and Trauma Focused-Cognitive Behavioral Therapy (TF-CBT) components for PTSD in youth. RRFT consists of seven primary components: Psychoeducation and Engagement, Coping, Family Communication, Substance Use, PTSD, Healthy Dating and Sexual Decision-Making, and Revictimization Risk Reduction. | Behavioural | RRFT (Risk Reduction through Family Therapy) |
| ENCOMPASS (Integrated Treatment for Adolescents and Young Adults)Encompass is currently a research to practice treatment for adolescents with co-occurring substance use disorders and mental health problems and is used as the standard treatment in the target study settings. | Behavioural | Treatment as Usual (TAU): Encompass |
Primary outcome
Timeline Follow Back (TFLB) - Change from baseline in # days non-tobacco substance used in past 28 days @ 3,6, and 12 months.
Time frame: Collected at baseline, 3, 6, & 12 months
The Timeline Follow Back (TLFB) is a validated, subjective measure that uses a calendar for people to provide estimates of substance use (drugs/alcohol) on a daily basis, retrospectively. Key dates and calendars are used to aid in memory recall. The measure is beneficial in both clinical and research environments. Over time, the TLFB looks for a decrease in substance use. Higher numbers of substance use are indicative of greater substance use.
UCLA PTSD Index DSM V - Change from baseline in UCLA PTSD total score @ 3,6, and 12 months
Time frame: Collected at baseline, 3, 6, & 12 months
The University of California, Los Angeles (UCLA) Post Traumatic Stress Disorder Index Diagnostic and Statistical Manuals 4th ed (DSM-IV; UCLA PTSD Index DSM-IV) is a validated, subjective measure that consists of 23 yes or no questions regarding the occurrence of different traumas or losses that may happen during a child's life. Each question is followed up with details of the trauma that occurred and more extensive questioning for the trauma experienced that is still most bothersome in the present day. These follow-up questions gauge symptoms of PTSD on a five-point Likert scale that ranges from "none" (score of 0, no days has this symptom occurred in the last month) to "most" (score of 4, symptom occurred almost every day in the past month). The most traumatic experience is also followed by several yes/no questions that gauge distress and functional impairment. Higher scores are indicative of higher rates of PTSD symptoms.
6 secondary outcomes
Urine Drug Screen (UDS) - Between group comparison -total # negative UDS /total # collected at baseline, 3, 6, & 12 months
Time frame: Collected at baseline, 3, 6, & 12 months
Timeline Follow Back (TFLB) - total # of days/28 day of cannabis use, alcohol use, and other non-nicotine substance use (excluding cannabis, alcohol).
Time frame: Collected at baseline, 3, 6, & 12 months
Response to Stress Questionnaire (RSQ) - Change from baseline in Adolescent/Child's Self-Report Responses to Family Stressors (subscale score items a-l)
Time frame: Change from baseline @ 3,6, and 12 months
Alabama Parenting Questionnaire (APQ) - positive parenting subscale, inconsistent discipline subscale, and supervision/monitoring subscale.
Time frame: Collected at baseline, 3, 6, & 12 months
Difficulties in Emotion Regulation Scale (DERS) - Change from baseline in total score @ 3, 6, & 12 mo f/u
Time frame: Change from baseline in total score @ 3, 6, & 12 month follow-up
Timeline Follow Back (TLFB) - Average quantity of specific substance used on days of use/28 days
Time frame: Collected at baseline, 3, 6, & 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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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.
Carla Kmett Danielson, PhD principal investigator
Medical University of South Carolina
Paula Riggs, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RRFT (Risk Reduction through Family Therapy) and ENCOMPASS (Integrated Treatment for Adolescents and Young Adults) in people with Substance Use Disorders and PTSD, run by Medical University of South Carolina at 2 sites 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Timeline Follow Back (TFLB) - Change from baseline in # days non-tobacco substance used in past 28 days @ 3,6, and 12 months. (time frame: Collected at baseline, 3, 6, & 12 months). The study lists 2 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 22 Apr 2026.