Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000109606
Ethics application status
Approved
Date submitted
15/01/2014
Date registered
29/01/2014
Date last updated
31/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of disordered sleep and anxiety in school-aged children
Scientific title
A randomised controlled trial of the effect of sleep restriction therapy on anxiety in school-aged children with insomnia
Secondary ID [1] 283912 0
nil
Universal Trial Number (UTN)
U1111-1152-1715
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 290909 0
Anxiety 290910 0
Condition category
Condition code
Mental Health 291262 291262 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in each of two treatment conditions will receive therapy based on principles of Cognitive Behaviour Therapy for Insomnia. Treatment will be provided by a Psychologist, Clinical Psychologist, or Provisional Psychologist.
1. Sleep restriction: reducing time-in-bed to 30 mins less than the usual average total sleep time. This will be achieved by shifting the child's usual bed time later by 30 minutes.
2. Bedtime restriction: reducing time-in-bed to match usual average total sleep time.
In both of these interventions, participants will attend two therapy sessions (one week apart, 1 hour on each occasion) and will implement their given schedule for a period of two weeks. Adherence to the intervention will be monitored using a 7-day sleep diary and wrist actigraphy.
Intervention code [1] 288594 0
Behaviour
Comparator / control treatment
Control participants will attend two therapy sessions (one week apart, 1 hour on each occasion). They will receive psycho-education (e.g., information about sleep architecture, REM sleep, circadian rhythms) and implement a regular & consistent bedtime schedule. This will be achieved by calculating their average time-in-bed across the baseline week, and then planning a schedule that involves being in bed for that amount of time each night (using a bed time and rise time that works for their household). This schedule will be implemented for a period of two weeks.
Adherence to the planned sleep schedule will be monitored using a 7-day sleep diary and wrist actigraphy. Treatment will be provided by a Psychologist, Clinical Psychologist, or Provisional Psychologist.
Control group
Active

Outcomes
Primary outcome [1] 291261 0
Sleep Parameters from Sleep Diary: time in bed, sleep onset latency, total sleep time, time awake after sleep onset, and sleep efficiency
Timepoint [1] 291261 0
post-treatment, 1-month follow-up
Primary outcome [2] 291262 0
Spence Children's Anxiety Scale (general anxiety and separation anxiety scales)
Timepoint [2] 291262 0
post-treatment, 1-month follow-up
Primary outcome [3] 291263 0
Worry Scale for Children - total score
Timepoint [3] 291263 0
post-treatment, 1-month follow-up
Secondary outcome [1] 306374 0
Paediatric Daytime Sleepiness Scale - total score
Timepoint [1] 306374 0
post-treatment, 1-month follow-up
Secondary outcome [2] 306385 0
Neuropsychological functioning (simple reaction time and digit span)
Timepoint [2] 306385 0
post-treatment

Eligibility
Key inclusion criteria
meet diagnostic criteria for Behavioural Insomnia of Childhood according to the International Classification of Sleep Disorders -2 manual
Minimum age
6 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Atypical development, English as a second language, non-psychological sleep disorders (e.g., sleep disordered breathing, parasomnias)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2014
Actual
9/04/2014
Date of last participant enrolment
Anticipated
Actual
15/03/2017
Date of last data collection
Anticipated
Actual
10/05/2017
Sample size
Target
60
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 288553 0
University
Name [1] 288553 0
Flinders University
Country [1] 288553 0
Australia
Primary sponsor type
Individual
Name
A/Prof Michael Gradisar
Address
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 287266 0
None
Name [1] 287266 0
Address [1] 287266 0
Country [1] 287266 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290416 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 290416 0
Ethics committee country [1] 290416 0
Australia
Date submitted for ethics approval [1] 290416 0
31/01/2014
Approval date [1] 290416 0
14/03/2014
Ethics approval number [1] 290416 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45582 0
Ms Neralie Cain
Address 45582 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 45582 0
Australia
Phone 45582 0
+61882012192
Fax 45582 0
Email 45582 0
[email protected]
Contact person for public queries
Name 45583 0
Neralie Cain
Address 45583 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 45583 0
Australia
Phone 45583 0
+61882012192
Fax 45583 0
Email 45583 0
[email protected]
Contact person for scientific queries
Name 45584 0
Neralie Cain
Address 45584 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 45584 0
Australia
Phone 45584 0
+61882012192
Fax 45584 0
Email 45584 0
[email protected]

No information has been provided regarding IPD availability


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.