Post Trauma NightmaresERRT-CNCT02184026
Exposure, Relaxation, & Rescripting Therapy-Child
A study testing Exposure, Relaxation, & Rescripting Therapy-Child in people with Post Trauma Nightmares and Traumatic Stress, run by University of Montana at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Post Trauma Nightmares, Traumatic Stress
- What is being tested?
- Exposure, Relaxation, & Rescripting Therapy-Child
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- adult, no traumatic experience, no nightmares, apparent psychosis, pervasive developmental disorder, or mental retardation, not able to read and speak English
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Post Trauma Nightmares, Traumatic Stress
- Being tested
- Exposure, Relaxation, & Rescripting Therapy-Child
- Keywords
- nightmare, PTSD, trauma, children, Children Age 8 to 13
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure, Relaxation, & Rescripting Therapy-ChildBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposure, Relaxation, & Rescripting Therapy-Child | Experimental | Exposure, Relaxation, \& Rescripting Therapy-Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring. Receives: Behavioral: Exposure, Relaxation, & Rescripting Therapy-Child |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startDec 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Trauma NightmaresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cameo Borntrager, University of Montana
- Investigators
- Cameo Borntrager, Ph.D., Principal investigator, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184026
- Sponsor's protocol ID
- MRA-778
- Acronym
- ERRT-C
- Status last verified
- Jun 2016
- First submitted
- 23 Jul 2013
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure, Relaxation, & Rescripting Therapy-Child
- ClinicalTrials.gov ID
- NCT02184026
- Acronym / sponsor ID
- ERRT-C / MRA-778
- Conditions
- Post Trauma Nightmares, Traumatic Stress
- Keywords
- nightmare, PTSD, trauma, children, Children Age 8 to 13
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure, Relaxation, & Rescripting Therapy-Child | Experimental | Behavioral: Exposure, Relaxation, & Rescripting Therapy-ChildExposure, Relaxation, \& Rescripting Therapy-Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- adult, no traumatic experience, no nightmares, apparent psychosis, pervasive developmental disorder, or mental retardation, not able to read and speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure, Relaxation, & Rescripting Therapy-ChildExposure, 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. | Behavioural | Exposure, Relaxation, & Rescripting Therapy-Child |
Primary outcome
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.
11 secondary outcomes
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
Revised Child Anxiety and Depression Scale (RCADS)
Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
Nightmare Distress Questionnaire - Modified (NDQ)
Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
Strength and Difficulties Questionnaire - Child Version (SDQ)
Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
Children's Sleep Habits Questionnaire (CSHQ)
Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
Strengths and Difficulties Questionnaire - Parent Version (SDQ)
Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
The Parenting Stress Scale (PSS)
Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
Pittsburgh Sleep Quality Index - Parent self-report (PSQI)
Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
The McMaster Family Assessment Device (FAD)
Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
Academic Grade Point Average (GPA)
Time frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cameo Borntrager, Ph.D. principal investigator
University of Montana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure, Relaxation, & Rescripting Therapy-Child in people with Post Trauma Nightmares and Traumatic Stress, run by University of Montana at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2016; AzTrials last refreshed its copy on 27 Oct 2026.