Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001200279
Ethics application status
Approved
Date submitted
12/07/2018
Date registered
18/07/2018
Date last updated
11/07/2019
Date data sharing statement initially provided
11/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive behavioural therapy for sleep disturbances in children with brain injury
Scientific title
Cognitive behavioural therapy for sleep disturbances following paediatric brain injury: A
multiple-baseline, single-case experimental design
Secondary ID [1] 295207 0
None
Universal Trial Number (UTN)
n/a
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury
 308343 0
Sleep disturbance 308345 0
Insomnia 308346 0
Condition category
Condition code
Neurological 307345 307345 0 0
Other neurological disorders
Injuries and Accidents 307346 307346 0 0
Other injuries and accidents
Mental Health 307347 307347 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised single-case experimental multiple baseline design, which includes a set sequence of phases: baseline, CBT-I, follow-up. The baseline duration is randomly determined. The baseline duration will be either 7 or 14 days. The duration of follow-up is 7 days. Cognitive behavioural therapy for insomnia (CBT-I) will be used in the study. This treatment aims to develop a consistent sleep-wake schedule and strengthen the association between bed and sleep by limiting time awake in bed. Participants will receive 4 x weekly sessions lasting 75-min each of individual manualised CBT-I that will include: sleep education, sleep hygiene, stimulus control and sleep restriction, and relapse prevention. Parents will also be involved in treatment. Homework will be assigned to participants each session, including maintaining a sleep diary during the treatment period. Participants will also be required to wear an actigraphy watch and complete a sleep diary during the baseline, follow up and treatment period. Parents will be provided with information about the treatment and asked to support children in the implementation of techniques learned during treatment. The treatment will be conducted by a Clinical Psychologist skilled in CBT and trained in implementation of adapted CBT treatments for insomnia for children with TBI developed for this study.
Intervention code [1] 301544 0
Behaviour
Comparator / control treatment
Participants will be randomly allocated to a baseline of either 7 or 14 days. Participants will complete sleep diaries and wear actigraphs during the allocated baseline.
On completion of treatment participants will complete sleep diaries for 7 days.
Average baseline sleep diary and actigraphy recordings will be compared to post-treatment recordings.
Participants will serve as their own controls.
Control group
Active

Outcomes
Primary outcome [1] 306327 0
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.

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.

The following measures will be administered:
(i) Treatment Evaluation Inventory - Short Form (TEI-SF; parent report)
(ii) Treatment Engagement Scale (TES; therapist report)
Timepoint [1] 306327 0
Process evaluation: On completion of treatment
TEI-SF: On completion of treatment
TES: On completion of each therapy session (1-4)
Secondary outcome [1] 348200 0
Sleep Disturbance (subjective assessment) assessed using the Sleep Disturbance Scale for Children (SDSC; parent report)
Timepoint [1] 348200 0
Baseline and immediately post-intervention
Secondary outcome [2] 348201 0
Sleep disturbance (objective assessment) assessed using Actigraphy combined with a structured sleep diary will record data on average sleep onset latency, night awakenings, total sleep duration, and sleep efficiency.
Timepoint [2] 348201 0
Baseline (7- or 14-days), during treatment (4-weeks), immediately post-intervention (7-days)
Secondary outcome [3] 348202 0
Insomnia severity assessed using the insomnia severity index (ISI; self-report)
Timepoint [3] 348202 0
Baseline and immediately post-intervention
Secondary outcome [4] 348203 0
Global rating of sleep quality assessed using the Pittsburugh Sleep Quality Index (PSQI; self-report)
Timepoint [4] 348203 0
Baseline and immediately post-intervention
Secondary outcome [5] 348204 0
Sleep Hygiene assessed using the Children's Sleep Hygiene Scale (CSHS; 2-12y parent report) or the Adolescent Sleep Hygiene Scale (13-18y; self-report)
Timepoint [5] 348204 0
Baseline and immediately post-intervention
Secondary outcome [6] 348205 0
Fatigue assessed using the PedsQL Multidimensional Fatigue Scale (PedsQL-MF; parent and self-report)
Timepoint [6] 348205 0
Baseline and immediately post-intervention
Secondary outcome [7] 348206 0
Pain assessed using the Faces Pain Scale Revised (FPS-R; self-report)
Timepoint [7] 348206 0
Baseline and immediately post-intervention
Secondary outcome [8] 348207 0
General behavioural functioning/mood assessed using the Child Behaviour Checklist (CBCL; parent report)
Timepoint [8] 348207 0
Baseline and immediately post-intervention
Secondary outcome [9] 348208 0
Cognition (executive functioning) assessed using the Behavioural Rating Scale of Executive Functions Second Edition (BRIEF-2)
Timepoint [9] 348208 0
Baseline and immediately post-intervention
Secondary outcome [10] 348209 0
Cognition (memory) assessed using the Everyday Memory Questionnaire (EMQ; parent and self-report)
Timepoint [10] 348209 0
Baseline and immediately post-intervention

Eligibility
Key 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.
Minimum age
11 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to 7- or 14-day baseline assessment sequentially from the schedule in a 1:1 ratio
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer random number generator (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study will utilise a randomised double-baseline single case experimental design (SCED), where participants will be randomly allocated to either 7-day or 14-day baseline assessment of sleep (actigraphy and sleep diary) and completion of outcome questionnaires. Following baseline assessment, all participants will complete the manualised sleep treatment. Follow-up assessment will involve completion of the outcome questionnaires and 7-day assessment of sleep (sleep diary and actigraphy)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary analysis (Feasibility): The primary outcome will be examined using descriptive statistics for process evaluation data (i.e., recruitment rate, trial retention etc.).

Secondary analysis (Efficacy): The secondary outcomes will be evaluated by comparing baseline and post-intervention outcome measures. For objective sleep measured by actigraphy and sleep diary we will undertake (i) visual inspection of time-series graphs, and (ii) compare scores at baseline, during treatment, and post-treatment, using SSD for R, a statistical program specifically designed for single subject research design. For subjective measures (i.e., questionnaires measuring sleep, fatigue, behaviour/mood, cognition, and pain) we will calculate reliable change indices using psychometric data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/07/2018
Actual
30/07/2018
Date of last participant enrolment
Anticipated
28/09/2020
Actual
Date of last data collection
Anticipated
30/11/2020
Actual
Sample size
Target
14
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11144 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 22967 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 299792 0
University
Name [1] 299792 0
The University of Sydney
Country [1] 299792 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
School of Psychology
Brennan MacCallum Building (A18)
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 299141 0
Hospital
Name [1] 299141 0
Sydney Children's Hospital
Address [1] 299141 0
Rehab2Kids, Brain Injury Rehabilitation Program
Sydney Children's Hospital Randwick
NSW 2031
Country [1] 299141 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300678 0
Sydney Children's Hospital Network Human Research Ethics Committee [EC00130]
Ethics committee address [1] 300678 0
Ethics committee country [1] 300678 0
Australia
Date submitted for ethics approval [1] 300678 0
Approval date [1] 300678 0
15/05/2018
Ethics approval number [1] 300678 0

Summary
Brief summary
Traumatic brain injury (TBI) has been recognised as a major public health issue by the World Health Organisation. Children are particularly susceptible. Children with TBI are at risk of life-long residual cognitive and behavioural deficits. Therefore, development of treatments that promote recovery and improve outcomes is of critical importance.
Our initial outcome study showed that 62% of children who sustain moderate to severe TBI experienced sleep disturbance. This is an important finding as sleep is vital for brain development, cognitive, and emotional health. At present, however, sleep disturbances remain largely undiagnosed and untreated after childhood TBI. Development and implementation of effective treatments for sleep disturbances is important, as improved sleep will promote recovery, brain development, cognitive and emotional health, and the wellbeing of children and families.

Aims:
This study aims to (i) determine the feasibility of CBT for insomnia (CBT-I) following child traumatic brain injury and (ii) determine the efficacy of CBT-I on sleep and secondary functional gains in fatigue, pain, behaviour/mood, and cognition.

Participants:
Seven children (age 11-16 years) who meet the following criteria will be recruited: (i) receiving outpatient treatment for TBI at the Brain Injury Rehabilitation Program, Sydney Children's Hospital Randwick; (ii) subclinical to clinical symptoms of insomnia (i.e., T-score >55) on the Sleep Disturbance Scale for Children or evidence of reduced sleep quality on actigraphy. In addition, a structured clinical interview will be conducted to evaluate children's sleep against the International Classification of Sleep Disorders (ICSD), 2nd Edition; and (iii) participant and family fluent in English.

Baseline assessment:
Participants will be randomised to 7- or 14-day baseline assessment of sleep (i.e., wear an actigraphy watch and complete a daily sleep diary) and questionnaires about sleep, fatigue, pain, behaviour/mood, and cognition.

Intervention:
All participants will then complete 4 x 75min weekly sessions of individual manualised CBT-I treatment during which time they will continue to wear an actigraphy watch and complete the daily sleep diary for the duration of the 4 weeks. Therapists delivering the intervention will rate participants' treatment engagement using a questionnaire after each treatment session.

Post-intervention assessment:
Following treatment, all participants will complete 7-day assessment of sleep (actigraphy and sleep diary) and questionnaires. They will also be asked to rate whether they found the intervention to be satisfactory and acceptable by completing an additional questionnaire on completion on treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84442 0
A/Prof Suncica Lah
Address 84442 0
Brennan MacCallum Building (A18)
School of Psychology
The University of Sydney
NSW 2006
Country 84442 0
Australia
Phone 84442 0
+61 293512648
Fax 84442 0
Email 84442 0
[email protected]
Contact person for public queries
Name 84443 0
A/Prof Suncica Lah
Address 84443 0
Brennan MacCallum Building (A18)
School of Psychology
The University of Sydney
NSW 2006
Country 84443 0
Australia
Phone 84443 0
+61 293512648
Fax 84443 0
Email 84443 0
[email protected]
Contact person for scientific queries
Name 84444 0
A/Prof Suncica Lah
Address 84444 0
Brennan MacCallum Building (A18)
School of Psychology
The University of Sydney
NSW 2006
Country 84444 0
Australia
Phone 84444 0
+61 293512648
Fax 84444 0
Email 84444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD has not been included in the ethics application.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.