跳至主要内容
临床试验/NCT04336072
NCT04336072已完成不适用

Trial of Reminder Focused Positive Psychiatry in Comorbid Attention Deficit Hyperactive Disorder With Posttraumatic Stress Disorder

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Feasibility of RFPP to treat adolescents with PTSD and ADHD

研究概览

简要总结

This feasibility study investigates the impact of reminder-focused-positive-psychiatry (RFPP) on attention-deficit-hyperactive-disorder (ADHD) and posttraumatic-stress-disorder (PTSD) symptoms, vascular-function, inflammation and well-being of adolescents with comorbid ADHD & PTSD.

In this randomized clinical trial, 24 subjects with comorbid ADHD and PTSD, aged 12-18 years old, free of known medical and other major psychiatric disorders, will be recruited from the pool of eligible subjects at Los Angeles and Kern County Children Mental Health Centers (>1500 subjects) after obtaining informed consent from parents as well as subjects' assentment. Commonwealth and Oswell Kern County Mental Health Clinic will be used for subjects enrollment, randomization as well as study implementation from trauma disorder clinic. Kern Medical will be used for manuscript write up and analyses.

Adolescents will be randomized to: group-RFPP or trauma-focused group-cognitive-behavioral-therapy (TF-CBT). Participants will complete twice-weekly-intervention for 6-weeks-trial. The group-RFPP-intervention will be inclusive of RFPP interventions on a) traumatic-reminders, and b Avoidance & negative-cognition. Vascular-function-measured as temperature-rebound (TR), C-reactive-protein (CRP), homocysteine, SNAP-questionnaire, Clinician-Administered PTSD-Scale-children-version (CAPS-CA) and neuropsychiatric-measures will be measured at baseline and 6th week. Subjects will be followed for 12 months.

Parents and subjects will be informed of the risks associated with use of venipuncture and loss of confidentiality of collected information.

详细描述

PTSD and ADHD are major public health problems. Many individuals with comorbid ADHD and PTSD continue to suffer despite treatment with FDA approved medications including antidepressants (sertraline and paroxetine), prazosin and/or the Institute of Medicine approved psychotherapy. Long-term outcomes with even the most intensive treatments, although significant, were modest, and reveal persistent morbidity and disability for many individuals with PTSD, especially in those with comorbid ADHD.19 While current treatments focused on treatment to reduce the associated suffering and disability of morbid ADHD and PTSD. These interventions are, however, not sufficient to promote human welfare, improve levels of positive psychosocial characteristics (PPCs), and resilience. Positive psychiatry (PP) focuses on promoting well-being, enhancing behavioral and mental wellness in both youth and adults20, however its impact on youth with comorbid PTSD and ADHD has not been studied. We hypothesize that PP intervention would significantly enhance vascular function, resilience, wellbeing, increase posttraumatic growth and reduce inflammation in morbid ADHD and PTSD. This randomized trial will the first to investigate the impact of psychiatric positive interventions, as opposed to intervention on ameliorating vulnerability, on adolescents with morbid ADHD and PTSD. Findings of this study can provide a better understanding of impact of PP on psychiatric and biomolecular characteristics of adolescent with PTSD and ADHD. If successful, this proposal will be available for large scale studies following which it could potentially be deployed in daily clinical practice.

RESEARCH METHOD:

In this randomized clinical trial, the three related and overlapping specific aims are directed to examine the feasibility of PP intervention, as well as its impact on positive psychological wellbeing, and neurovascular inflammation in adolescent subjects with comorbid ADHD and PTSD.

Synopsis. In this randomized clinical trial, 24 subjects with comorbid ADHD and PTSD, aged 12-18 years old, free of known medical and other major psychiatric disorders, will be recruited from the pool of eligible subjects at Los Angeles and Kern County Children Mental Health Centers (>1500 subjects) after obtaining informed consent from parents as well as subjects' assentment. Commonwealth and Oswell Kern County Mental Health Clinic will be used for subjects enrollment, randomization as well as study implementation from trauma disorder clinic. Kern Medical will be used for manuscript write up and analyses.

Parents and subjects will be informed of the risks associated with use of venipuncture and loss of confidentiality of collected information. Eligible subjects will be randomized to 1) PP group intervention, or 2) control condition group (12 in each group) for 6 week intervention and 6 week of follow up.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participants will be randomly assigned to groups. Outcome assessors will be blinded to participants and interventions

入排标准

年龄范围
9 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking Boy/Girl Age 9 - 18 years old
  • Able to read/write in English
  • Documented ADHD and PTSD, and parents provided informed consent

排除标准

  • Psychotic or Mood Disorders or Self-injurious behavior
  • Cognitive disorder or other neurodevelopmental disorders
  • Diagnosis of substance use disorder

结局指标

主要结局

Feasibility of RFPP to treat adolescents with PTSD and ADHD

时间窗: 12 month

Measure the feasibility of RFPP intervention measured by retention rate of participants in RFPP group post-intervention. The goal is a ≥50% referred-to-enrolled rate, ≥70% intervention completion rate and 70% 12-month follow up.

Acceptability of RFPP to treat adolescents with PTSD and ADHD

时间窗: 12 month

Measure the acceptability after 6-week intervention where both adolescents and parents will be asked about overall satisfaction with treatment using the validated and reliable Client Satisfaction Questionnaire (CSQ-8). The aim is a mean above 20.00 (Good-Excellent) on the 8 to 32 scale of CSQ-8, and sessions' mean of 4.00 (very valuable session) on the 0 to 5 Session Feedback Questionnaire scale (SFQ).

Fidelity of RFPP to treat adolescents with PTSD and ADHD

时间窗: 12 month

Measure the adherence and competence of therapists to the model will be assessed by live observation, role play and provider self-report and checklist. Session will observed or listened to as they are happening. Therapists demonstrate specific skills which might use with a client generically and as applied to specific clinical cases required by the model. Therapists describe in detail exactly what they do in the session and how the client respond, also complete checklists following sessions. Interrater reliability will be assessed using the chance-corrected weighted kappa statistic from 0-1, with aim of 0.8+ (almost perfect agreement).

次要结局

  • Change in mental wellbeing in response of RFPP at 6-week intervention and 12-month follow up.(12 month)
  • Change in PTSD symptoms in response of RFPP at 6-week intervention and 12-month follow up.(12 month)
  • Change in ADHD symptoms in response of RFPP at 6-week intervention and 12-month follow up.(12 month)
  • Change in physiologic biomarkers in response of RFPP at 6-week intervention and 12-month follow up.(12 month)
  • Change in the rate of psychiatric hospitalization and suicidality in response of RFPP at 6-week intervention and 12-month follow up.(12 month)

研究者

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

Naser Ahmadi, MD, PhD

Assistant Professor of Psychiatry

University of California, Los Angeles

研究点 (2)

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