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Completed

NCT Number: NCT02184026

Exposure, Relaxation, & Rescripting Therapy-Child

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.

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Key information

Conditions

Post Trauma Nightmares Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Traumatic Stress Wounds and Injuries

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Montana

Missoula, Montana, 59812, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure, Relaxation, & Rescripting Therapy-Child

Behavioral

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.

Primary outcomes

  1. Trauma Related Nightmare Survey - Child Version (TRNS-C) Reflecting change in nightmare frequency, severity, and duration

    Time frame: 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.

    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.

Secondary outcomes

  1. 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)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    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.

  2. Revised Child Anxiety and Depression Scale (RCADS)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    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.

  3. Nightmare Distress Questionnaire - Modified (NDQ)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    The NDQ is a 13-item self-report measure of nightmare related distress. Higher scores are significantly related to interest in therapy for nightmares.

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    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.

  5. Strength and Difficulties Questionnaire - Child Version (SDQ)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    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).

  6. Children's Sleep Habits Questionnaire (CSHQ)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    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.

  7. Strengths and Difficulties Questionnaire - Parent Version (SDQ)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    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).

  8. The Parenting Stress Scale (PSS)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    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").

  9. Pittsburgh Sleep Quality Index - Parent self-report (PSQI)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    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.

  10. The McMaster Family Assessment Device (FAD)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    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.

  11. Academic Grade Point Average (GPA)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    GPA will be collected as a measure of academic performance.

Other outcomes

  1. Trail Making Test

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    A neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. It provides information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.

  2. Wechsler Intelligence Scale for Children (WISC-IV), Letter-Number Sequencing subtest

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    A measure of attention, short-term auditory memory, and processing speed.

  3. Wechsler Intelligence Scale for Children (WISC-IV), Digit Span subtest

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    A measure of auditory short-term memory, attention, and concentration.

  4. Child Attention Network Task

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    A task designed to test attention shifting, alerting, orienting, and executive control networks.

  5. A Developmental NEuroPSYchological Assessment (NEPSY-II), Animal Sorting subtest

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    A measure of attention and executive functions.

  6. A Developmental NEuroPSYchological Assessment (NEPSY-II), Auditory Attention & Response Set subtest

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    A measure of attention and executive functions.

  7. A Developmental NEuroPSYchological Assessment (NEPSY-II), Clocks subtest

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    A measure of attention and executive functions.

  8. Aimsweb Reading Curriculum-Based Measurement (R-CBM)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    A measure designed to be a short (one minute) fluency measure used to regularly monitor the development of early literacy and early reading skills. Results can be used to evaluate individual student development.

  9. Aimsweb MAZE Reading Curriculum-Based Measurement (MAZE-CBM)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    A supplemental measure to provide a more complete picture of a child's reading skill. Maze is a multiple-choice task that children complete while reading silently. The first sentence of a 150-400 word passage is left intact. Thereafter, every 7th word is replaced with three words inside parenthesis. The child must choose the correct word.

  10. Peabody Picture Vocabulary Test, Fourth Edition (PPVT-4)

    Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups

    A standardized assessment that evaluates receptive language, as an index of cognitive ability.

Sponsors and collaborators

Lead sponsor

University of Montana

Other

Registry information

Acronym: ERRT-C

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2014
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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