An Open Clinical Trial of Interpersonal Psychotherapy for Adolescents With PTSD Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Clinician-Administered PTSD Scale for DSM-5, Child/Adolescent Version (CAPS-CA-5)
研究概览
简要总结
In the present study, the investigators propose to 1) adapt Interpersonal Psychotherapy for Adolescents (IPT-A) as an intervention for adolescents who report elevated symptoms of posttraumatic stress disorder (PTSD) and/or meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for PTSD; and 2) conduct a small open pilot study of IPT-A for PTSD. Ten adolescents ages 13 to 18 who meet DSM-5 criteria for a PTSD diagnosis or have elevated symptoms of PTSD (Child PTSD Symptom Scale [CPSS-5] ≥ 31) will be treated with 14-16 weeks of an adapted version of IPT-A. If participants have evidenced a decrease in PTSD symptoms (CPSS-5 < 31) they will also receive 3 months of once a month maintenance treatment and be assessed by a clinician evaluator at the conclusion of the 3 monthly sessions. If participants have not evidenced a decrease in PTSD symptoms (CPSS-5 ≥ 31), they will be referred for alternative treatments in the community and be assessed by a clinician evaluator 3 months following the completion of IPT-A. All evaluations and therapy sessions will be done over telehealth platform until able to be done in person.
详细描述
Please see the brief summary for study description.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents who meet criteria for DSM-5 diagnosis of PTSD or have elevated PTSD symptoms
- •English speaking adolescent and parent
- •Males and Females ages 13-18 years
- •Mild to moderate impairment in functioning
排除标准
- •Severe impairment in functioning
- •Diagnoses of substance abuse, Schizophrenia, Bipolar Disorder, Conduct Disorder, primary eating disorder, psychotic symptoms
- •Engagement in significant self-injurious behavior in the past 3 months
- •Active suicidality - presence of plan and/or intent
- •Intellectual disability or severe learning disability
- •Medical illness that may interfere with treatment
- •Current physical or sexual abuse
- •Open Administration for Children's Services (ACS) case
- •Currently receiving treatment for depression and/or PTSD or have begun a medication trial for another diagnosis within the previous three months
结局指标
主要结局
Change in Clinician-Administered PTSD Scale for DSM-5, Child/Adolescent Version (CAPS-CA-5)
时间窗: baseline, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 4 weeks prior to the assessment date.
The Clinician-Administered Post-Traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DMS-5) - Child/Adolescent Version (CAPS-CA-5) is a 30-item scale that assesses PTSD in children and adolescents ages 7 and older based on the 20 DSM-5 PTSD symptoms. Each item is given a severity rating based on symptom frequency and intensity. Ratings are given for the 4 weeks prior to each assessment timepoint. A total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms and ranges from 0-80, with a higher score indicating greater symptom severity. The CAPS-CA-5 will be used to assess change in symptoms through study completion at the 3-month follow-up assessment. The measure will be administered at baseline rating the prior 4 weeks, between weeks 14-16 (post-intervention) rating the prior 4 weeks, and at the 3-month follow-up assessment rating the prior 4 weeks.
Change in Child PTSD Symptom Scale (CPSS-5)
时间窗: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 4 weeks prior to the assessment date.
The Child Post-Traumatic Stress Disorder (PTSD) Symptom Scale (CPSS-5) is a self-report scale designed to assess PTSD symptoms in children and adolescents ages 8-18. The measure screens for stressful life events and asks about the emotional impact of these events in the 4 weeks prior to the assessment. Items are rated on a 5-point scale from 0 (not at all) to 4 (almost always) for how often the problem bothers the youth in the prior 4 weeks. A total symptom severity rating is calculated by summing the ratings of all 20 items and ranges from 0-80, with a higher score indicating greater symptom severity. The CPSS-5 will be used to assess change in PTSD symptoms through study completion at the 3-month follow-up assessment. The scale will be completed at baseline about the prior 4 weeks, at week 7 about the prior 4 weeks, between weeks 14-16 (post-intervention) about the prior 4 weeks, and at the 3-month follow-up assessment about the prior 4 weeks.
Change in Clinical Global Scale of Illness - Improvement/Severity (CGI-I/S)
时间窗: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date
The Clinical Global Scale of Illness - Improvement/Severity (CGI-I/S) is a 2-item clinician-rated instrument that assesses change in global illness severity and global improvement from baseline prior to treatment to study completion at the 3-month follow-up assessment. The improvement item is scored on a 7-point scale and ranges from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). The severity item is scored on a 7-point scale and ranges from 1 (normal) to 7 (among the most extremely ill patients). It will be administered at baseline rating the prior 2 weeks, at week 7 rating the prior 2 weeks, between weeks 14-16 (post-intervention) rating the prior 2 weeks, and at the 3-month follow-up assessment rating the prior 2 weeks.
次要结局
- Change in Mood and Feelings Questionnaire (MFQ)(baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date)
- Change in Social Adjustment Scale-Self Report (SAS-SR)(baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date)
- Change in Columbia-Suicide Severity Rating Scale (C-SSRS)(lifetime from birth to baseline time period, the month (4 weeks) prior to the initial baseline assessement prior to treatment, and at weeks 7, 14-16 (post intervention) and 3 month follow-up ratings on behavior since prior assessment up to 36 weeks.)
- Change in Conflict Behavior Questionnaire (CBQ)(baseline, week 7, between weeks 14-16(post-intervention), and at the 3 month follow-up, each time rating the past 2 weeks prior to the assessment date.)
- Change in Children's Global Assessment Scale (CGAS)(baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the past 4 weeks prior to the assessment date)
研究者
Laura Mufson
Professor of Medical Psychology (in Psychiatry)
New York State Psychiatric Institute