Cognitive behavioural therapy for sleep disturbances in children with brain injury

Not Applicable

Recruiting

• Conditions: Traumatic brain injury; Sleep disturbance; Insomnia; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents; Mental Health - Other mental health disorders

• Registration Number: ACTRN12618001200279
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-18
• Last Update Posted: 22 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

(i) Individuals who have sustained a traumatic brain injury (TBI) of any severity
(ii) Aged 11 to 16 years
(iii) Receiving outpatient treatment for TBI at the Brain Injury Rehabilitation Program at Sydney Children's Hospital Randwick
(iv) Sub-clinical to clinical symptoms of insomnia (i.e., T-score >55 on the Sleep Disturbances Scale for Children) or evidence of reduced sleep quality on Actigraphy. In addition, a structured clinical interview will be conducted prior to commencement of treatment to evaluate children's sleep against the International Classification of Sleep Disorders (ICSD), 2nd Edition.

Exclusion Criteria

(i) Individuals and families that are not fluent in English
(ii) Aged <11 years
(iii) Individuals with sleep disorders that are not amenable to behavioural treatment (e.g., sleep breathing disorder or sleep hyperhidrosis)
(iv) Individuals with significant cognitive and/or physical impairments

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility will be determined via process evaluation, conducted according to MRC guidance and will provide information on recruitment rate, refusal rate, trial retention and follow-up rates, adherence rates to treatment, and attendance. <br><br>The process evaluation will also appraise inclusion criteria, data collection methods (i.e., participant burden), fidelity and quality of treatment implementation, and participants' engagement, satisfaction and feedback. <br><br>The following measures will be administered:<br>(i) Treatment Evaluation Inventory - Short Form (TEI-SF; parent report) <br>(ii) Treatment Engagement Scale (TES; therapist report)[Process evaluation: On completion of treatment<br>TEI-SF: On completion of treatment<br>TES: On completion of each therapy session (1-4)]