Exposure, Relaxation, & Rescripting Therapy-Child

Traumatic Stress Clinical Trial

— ERRT-C  

Official title:

Exposure, Relaxation, & Rescripting Therapy-Child

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184026
• Other study ID #: MRA-778
• Status: Completed
• Phase: N/A
• First received: July 23, 2013
• Last updated: June 17, 2016
• Start date: December 2012
• Est. completion date: April 2015

Study information

• Verified date: June 2016
• Source: University of Montana
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Trauma Nightmares
• Traumatic Stress

Intervention

Behavioral:
• Exposure, Relaxation, & Rescripting Therapy-Child
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.

Locations

Country	Name	City	State
United States	University of Montana	Missoula	Montana

Sponsors (1)

Lead Sponsor	Collaborator
University of Montana

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Trail Making Test	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.	1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups	No
Other	Wechsler Intelligence Scale for Children (WISC-IV), Letter-Number Sequencing subtest	A measure of attention, short-term auditory memory, and processing speed.	1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups	No
Other	Wechsler Intelligence Scale for Children (WISC-IV), Digit Span subtest	A measure of auditory short-term memory, attention, and concentration.	1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups	No
Other	Child Attention Network Task	A task designed to test attention shifting, alerting, orienting, and executive control networks.	1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups	No
Other	A Developmental NEuroPSYchological Assessment (NEPSY-II), Animal Sorting subtest	A measure of attention and executive functions.	1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups	No
Other	A Developmental NEuroPSYchological Assessment (NEPSY-II), Auditory Attention & Response Set subtest	A measure of attention and executive functions.	1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups	No
Other	A Developmental NEuroPSYchological Assessment (NEPSY-II), Clocks subtest	A measure of attention and executive functions.	1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups	No
Other	Aimsweb Reading Curriculum-Based Measurement (R-CBM)	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.	1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups	No
Other	Aimsweb MAZE Reading Curriculum-Based Measurement (MAZE-CBM)	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.	1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups	No
Other	Peabody Picture Vocabulary Test, Fourth Edition (PPVT-4)	A standardized assessment that evaluates receptive language, as an index of cognitive ability.	1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups	No
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No