Exposure, Relaxation, & Rescripting Therapy-Child

Study Overview
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Brief Summary
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The study implements a trauma-related nightmare treatment for children aged 8 to 13 years. Relevant outcome progress and outcome measures on symptoms, nightmare distress and duration, academic indicators, and sleep quality will be examined.

Detailed Description
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Untreated trauma-related nightmares and sleep-related disorders are associated with chronic health problems, burdening both the suffering individual and the health-care system. The study implements an innovative, cost-efficient, nightmare treatment for trauma-exposed children. It is one of the first randomized clinical trials with children, adapting an efficacious adult therapy to a 5-session nightmare treatment for 8-13 year-olds. Trauma nightmares are a mechanism in development and maintenance of secondary post-trauma psychopathology, medical problems, and family dysfunction. Therefore, this treatment may prevent long-term secondary health and behavioral problems. It provides a viable health care option to Montanans, lessening long-term financial, medical, and behavioral health expenses. Scientific models currently view PTSD treatment as primary, often leaving nightmares untreated. That approach does not address the pernicious impact of trauma-nightmares in individuals with sub-threshold PTSD or whose nightmares are a primary condition. The theoretical innovation of this therapy can advance the field's understanding of the development of trauma sequelae.

Official Title
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Exposure, Relaxation, & Rescripting Therapy-Child

Conditions
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Post Trauma Nightmares, Traumatic Stress

Intervention / Treatment
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* Behavioral: Exposure, Relaxation, & Rescripting Therapy-Child


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children age 8-13 with PTSD Criterion A event as defined by the DSM-IV and nightmares occurring at least once per week over a minimum of one month have a parent or legal guardian who is able to participate in treatment assignments at home and be able to read and speak English Exclusion Criteria: adult, no traumatic experience, no nightmares, apparent psychosis, pervasive developmental disorder, or mental retardation, not able to read and speak English

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure, Relaxation, & Rescripting Therapy-Child<br>Exposure, Relaxation, & Rescripting Therapy-Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring. | Behavioral: Exposure, Relaxation, & Rescripting Therapy-Child<br>* Exposure, Relaxation, & Rescripting Therapy (ERRT) will be conducted once a week for five consecutive weeks for approximately two hours per session. Each treatment session focuses on one of the following topics/skills: psycho-education and investment in treatment, psycho-education, Progressive Muscle Relaxation, diaphragmatic breathing, child-friendly exposure to the trauma-nightmare, and rescription.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trauma Related Nightmare Survey - Child Version (TRNS-C) Reflecting change in nightmare frequency, severity, and duration | The TRNS-C is a 14-item self-report measure that assesses current sleep quality, frequency, severity, and duration of nightmares, as well as cognitions, emotions, and behaviors related to nightmares in children. | Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for follow-ups at 3 months & 6 months post treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| University of California at Los Angeles Post-traumatic Stress Disorder Reaction Index for the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) (UPID) | The UPID screens for trauma exposure and posttraumatic symptoms among youth 7 to 18 years old. It queries types of trauma exposures, assesses for DSM-IV criteria of traumatic exposure and the past-month frequency of PTSD symptoms and two associated features of PTSD in childhood. | 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups | 
| Revised Child Anxiety and Depression Scale (RCADS) | The RCADS is a 47-item scale that corresponds to the DSM-IV anxiety disorders and it incorporates a sub scale for major depression. There is a six-factor structure with the following sub scales: Separation Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder, Panic Disorder, and Major Depressive Disorder. | 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups | 
| Nightmare Distress Questionnaire - Modified (NDQ) | The NDQ is a 13-item self-report measure of nightmare related distress. Higher scores are significantly related to interest in therapy for nightmares. | 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups | 
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a 19-item self-report measure of sleep quality and disturbance. It queries sleep quality and disturbances over the last month. Seven component scores are generated from this measure including: subjective sleep quality, latency, duration, habitual sleep efficiency, sleep problems, use of sleep medications, and daytime dysfunction. | 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups | 
| Strength and Difficulties Questionnaire - Child Version (SDQ) | The SDQ is a self-report instrument designed for completion by 11-16 year-olds. Specifically, children respond to 25 attributes (emotional, conduct, hyperactivity, peer relationships, and prosocial behaviors). | 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups | 
| Children's Sleep Habits Questionnaire (CSHQ) | The CSHQ is a 33-item parent-report measure of sleep behavior that can be used by parents of school-aged children. A total score is derived from items from 8 sub scales: Bedtime Resistance, Sleep Onset Delay, Sleep Duration, Sleep Anxiety, Night Wakings, Parasomnias, Sleep-Disordered Breathing, and Daytime Sleepiness. | 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups | 
| Strengths and Difficulties Questionnaire - Parent Version (SDQ) | The SDQ has two parent versions designed for 4-10 year-olds and 11-16 year-olds. Specifically, parents respond to 25 attributes (emotional, conduct, hyperactivity, peer relationships, and prosocial behavior). | 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups | 
| The Parenting Stress Scale (PSS) | The PSS is an 18-item measure that assesses stress related to parenting (e.g., I am happy in my role as a parent, Having child(ren) has been a financial burden). | 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups | 
| Pittsburgh Sleep Quality Index - Parent self-report (PSQI) | Similar to the child version, the adult form of the PSQI is a 19-item self-report measure of sleep quality and disturbance. It queries sleep quality and disturbances over the last month. It will serve as an index of secondary gain from treatment by way of parent's improved sleep quality and quantity. | 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups | 
| The McMaster Family Assessment Device (FAD) | The FAD is a 53-item measure that identifies seven dimensions of family functioning: Problem Solving, Communication, Roles, Affective Responses, Affective Involvement, Behavior Control, and General Functioning. | 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups | 
| Academic Grade Point Average (GPA) | GPA will be collected as a measure of academic performance. | 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nightmare, PTSD, trauma, children, Children Age 8 to 13