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
This study aims to determine if treatment for insomnia also reduces anxiety in school-aged children. Compared to children in the control group, we expect children in both treatment groups to show improvements in sleep and anxiety, with greatest improvements expected for the "moderate" treatment group.
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
Ms 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
Ms 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.