Exposure, Relaxation, & Rescripting Therapy-Child

NCT ID: NCT01776229

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-11-30

Brief Summary

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 the first randomized clinical trial with children, adapting an efficacious adult therapy to a 5-session nightmare treatment for 5-17 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 healthcare option to Oklahomans, 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

Nightmares Associated With Trauma and Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioral

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

Group Type: EXPERIMENTAL

Exposure, Relaxation, & Rescripting Therapy-Child

Intervention Type: 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.

Waitlist Control

All potential participants will be evaluated and some will be randomly placed in the control group, following the five-week treatment phase, participants in the control group will be re-evaluated and offered the treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• children age 5-17 with traumatic or potentially traumatic/adverse experiences 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
• in order to ensure the verbal comprehension of the child, the PPVT will be used to help evaluate if a child is suitable for treatment, as an index to ensure they can verbally comprehend the cognitive component of treatment

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tulsa

OTHER

Sponsor Role: lead

Responsible Party

Lisa Cromer

Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Cromer, Phd

Role: PRINCIPAL_INVESTIGATOR

The University of Tulsa

Locations

The University of Tulsa Institute for Trauma Abuse and Neglect

Tulsa, Oklahoma, United States

Countries

United States

Related Links

https://www.facebook.com/ChildNightmareStudy

Child Nightmare Study Facebook Information Page

Other Identifiers

TU 11-63RI

Identifier Type: -

Identifier Source: org_study_id