Clinical trial NCT05384223: Evaluation of RRFT for Co-occurring SUD and PTSD Among Teens
Official title: Evaluation of Clinical Effectiveness, Cost, and Implementation Factors to Optimize Scalability of Treatment for Co-occurring SUD and PTSD Among Teens
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
PTSD
Keywords: Treatment
Adolescent Substance Use
PTSD
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Indiana University School of Medicine
name: Oregon Social Learning Center
First posted: 2022-05-20
Enrollment: 212
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Aged 13-19 years;
2. 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.;
3. Five or more current DSM-V PTSD symptoms as assessed on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)/UCLA PTSD Index;
4. 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;
5. A current (past year) non-nicotine substance use disorder (SUD) as assessed on the K-SADS;
6. English-speaking.

Exclusion Criteria:

1. 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
2. Actively suicidal/homicidal;
3. Active psychosis.

Primary outcomes:
measure: Timeline Follow Back (TFLB) - Change from baseline in # days non-tobacco substance used in past 28 days @ 3,6, and 12 months.
timeFrame: Collected at baseline, 3, 6, & 12 months
measure: UCLA PTSD Index DSM V - Change from baseline in UCLA PTSD total score @ 3,6, and 12 months
timeFrame: Collected at baseline, 3, 6, & 12 months
Secondary outcomes:
measure: Urine Drug Screen (UDS) - Between group comparison -total # negative UDS /total # collected at baseline, 3, 6, & 12 months
timeFrame: Collected at baseline, 3, 6, & 12 months
measure: Timeline Follow Back (TFLB) - total # of days/28 day of cannabis use, alcohol use, and other non-nicotine substance use (excluding cannabis, alcohol).
timeFrame: Collected at baseline, 3, 6, & 12 months
measure: Response to Stress Questionnaire (RSQ) - Change from baseline in Adolescent/Child's Self-Report Responses to Family Stressors (subscale score items a-l)
timeFrame: Change from baseline @ 3,6, and 12 months
measure: Alabama Parenting Questionnaire (APQ) - positive parenting subscale, inconsistent discipline subscale, and supervision/monitoring subscale.
timeFrame: Collected at baseline, 3, 6, & 12 months
measure: Difficulties in Emotion Regulation Scale (DERS) - Change from baseline in total score @ 3, 6, & 12 mo f/u
timeFrame: Change from baseline in total score @ 3, 6, & 12 month follow-up
measure: Timeline Follow Back (TLFB) - Average quantity of specific substance used on days of use/28 days
timeFrame: Collected at baseline, 3, 6, & 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: CU Medicine Psychiatry - Outpatient Clinic
state: Colorado
city: Denver
country: United States
facility: ARTS - Synergy Outpatient Services
state: Colorado
Study officials:
affiliation: Medical University of South Carolina
name: Carla Kmett Danielson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Paula Riggs, PhD
role: PRINCIPAL_INVESTIGATOR
References: