NCT02184026

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
12 months until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

2.3 years

First QC Date

July 23, 2013

Last Update Submit

June 17, 2016

Conditions

Keywords

nightmarePTSDtraumachildrenChildren Age 8 to 13

Outcome Measures

Primary Outcomes (1)

  • 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 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)

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

  • Revised Child Anxiety and Depression Scale (RCADS)

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

  • Nightmare Distress Questionnaire - Modified (NDQ)

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

  • Pittsburgh Sleep Quality Index (PSQI)

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

  • Strength and Difficulties Questionnaire - Child Version (SDQ)

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

  • +6 more secondary outcomes

Other Outcomes (10)

  • Trail Making Test

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

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

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

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

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

  • +7 more other outcomes

Study Arms (1)

Exposure, Relaxation, & Rescripting Therapy-Child

EXPERIMENTAL

Exposure, Relaxation, \& Rescripting Therapy-Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.

Behavioral: Exposure, Relaxation, & Rescripting Therapy-Child

Interventions

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.

Exposure, Relaxation, & Rescripting Therapy-Child

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • adult, no traumatic experience, no nightmares, apparent psychosis, pervasive developmental disorder, or mental retardation, not able to read and speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Montana

Missoula, Montana, 59812, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Cameo Borntrager, Ph.D.

    University of Montana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 8, 2014

Study Start

December 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 20, 2016

Record last verified: 2016-06

Locations