跳至主要内容
临床试验/NCT05384223
NCT05384223进行中(未招募)不适用

Evaluation of Clinical Effectiveness, Cost, and Implementation Factors to Optimize Scalability of Treatment for Co-occurring SUD and PTSD Among Teens

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2022年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
212
试验地点
2
主要终点
Timeline Follow Back (TFLB) - Change from baseline in # days non-tobacco substance used in past 28 days @ 3,6, and 12 months.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Randomization will be monitored by the Principal Investigator.

入排标准

年龄范围
13 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

RRFT (Risk Reduction through Family Therapy)

Experimental

干预措施: RRFT (Risk Reduction through Family Therapy) (Behavioral)

Treatment as Usual (TAU): Encompass

Active Comparator

干预措施: ENCOMPASS (Integrated Treatment for Adolescents and Young Adults) (Behavioral)

结局指标

主要结局

Timeline Follow Back (TFLB) - Change from baseline in # days non-tobacco substance used in past 28 days @ 3,6, and 12 months.

时间窗: 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

时间窗: 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.

次要结局

  • Timeline Follow Back (TFLB) - total # of days/28 day of cannabis use, alcohol use, and other non-nicotine substance use (excluding cannabis, alcohol).(Collected at baseline, 3, 6, & 12 months)
  • Alabama Parenting Questionnaire (APQ) - positive parenting subscale, inconsistent discipline subscale, and supervision/monitoring subscale.(Collected at baseline, 3, 6, & 12 months)
  • Urine Drug Screen (UDS) - Between group comparison -total # negative UDS /total # collected at baseline, 3, 6, & 12 months(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)(Change from baseline @ 3,6, and 12 months)
  • Difficulties in Emotion Regulation Scale (DERS) - Change from baseline in total score @ 3, 6, & 12 mo f/u(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(Collected at baseline, 3, 6, & 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carla Kmett Danielson

Dr. Carla Kmett Danielson, Principal Investigator

Medical University of South Carolina

研究点 (2)

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