Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000466842
Ethics application status
Approved
Date submitted
11/02/2021
Date registered
20/04/2021
Date last updated
22/03/2022
Date data sharing statement initially provided
20/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Acceptability and Efficacy of a Parent-Mediated Video Conferencing Intervention for Treatment of Sleep Problems in Preschool Aged Children: A Randomised Controlled Trial
Scientific title
The Acceptability and Efficacy of a Parent-Mediated Video Conferencing Intervention for Treatment of Sleep Problems in Preschool Aged Children: A Randomised Controlled Trial
Secondary ID [1] 303404 0
None
Universal Trial Number (UTN)
U1111-1264-8191
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Problems 320728 0
Condition category
Condition code
Mental Health 318570 318570 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The sleep program will consist of 3 x 1.5 hour fortnightly parent sessions conducted over video conference. The program includes psychoeducation on sleep and sleep hygiene, teaches parents strategies to implement a wind-down routine, ensure a consistent bed and wake time, develop sleep-related behaviour charts and exposure hierarchies, and deal with bedtime fears, oppositional child bed-time behaviour, co-sleeping and night-time wakening. The educational content (including reference materials emailed to parents) was designed for the face-to-face version of this program and was amended specifically for this study.

Clinicians will be provisionally registered Psychologists undertaking postgraduate training in clinical psychology. They will receive 6 hours of training by A/Prof Caroline Donovan. Clinicians will be supervised by A/Prof Donovan and A/Prof Farrell, both of whom are fully registered Clinical Psychologists. All treatment sessions will be video-recorded and independently assessed for treatment fidelity and adherence.
Intervention code [1] 319732 0
Treatment: Other
Intervention code [2] 319973 0
Behaviour
Comparator / control treatment
Parents in the waitlist condition will be able to access any other child sleep services available during the course of the study. They will be offered the program after the final follow-up, 5-months post randomisation.
Control group
Active

Outcomes
Primary outcome [1] 326524 0
Acceptability of treating sleep problems in preschool aged children using parent-mediated video conferencing assessed by a treatment satisfaction scale designed for this project.
Timepoint [1] 326524 0
2 weeks post treatment completion
Primary outcome [2] 326525 0
Child sleep problems as assessed by:
Child Sleep Habits Questionnaire (Owens et al., 2000)
Timepoint [2] 326525 0
Baseline, 2 months post-randomisation and 5-months post-randomisation
Primary outcome [3] 326822 0
Child sleep problems as assessed by:
Parent rating of sleep problem (none, mild, moderate, severe)
Timepoint [3] 326822 0
Baseline, 2 months post-randomisation and 5-months post-randomisation
Secondary outcome [1] 391784 0
Child sleep problems as assessed by:
1.. 7-day sleep diary designed for this study
Timepoint [1] 391784 0
Baseline, 2 months post-randomisation and 5-months post-randomisation
Secondary outcome [2] 391785 0
Child anxiety problems as assessed by:
The Pre-school Anxiety Scale (Spence et al., 2001)
Timepoint [2] 391785 0
Baseline, 2 months post-randomisation and 5-months post-randomisation
Secondary outcome [3] 391786 0
Parenting, parenting stress and family functioning as assessed by:
The Parenting and Family Adjustment Scales (PAFAS; Sanders et al, 2014)
Timepoint [3] 391786 0
Baseline, 2 months post-randomisation and 5-months post-randomisation
Secondary outcome [4] 392810 0
Dark and night fears measured by a scale created for the project
Timepoint [4] 392810 0
Baseline, 2 months post-randomisation and 5-months post-randomisation
Secondary outcome [5] 393174 0
Acceptability of treating sleep problems in preschool aged children using parent-mediated video conferencing assessed by a 10-15 minute semi structured interview
Timepoint [5] 393174 0
2 weeks post treatment

Eligibility
Key inclusion criteria
Children will be included in the study if they a) score above 41 on the Child Sleep Habits Questionnaire, and b) are rated as having a ‘moderate’ or ‘severe’ sleep problem through parent report on the screening survey and c) aged 3, 4 or 5 years of age at enrolment.. Parents must be willing to participate in either of the two conditions, consent to being filmed, and agree to complete online assessments.
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will be excluded from the study if they have a parent-reported intellectual or developmental disorder, as the sleep program is designed for neurotypical children.

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 randomised after screening and baseline measures have been completed. Randomisation will be performed by a researcher independent of the project using a web-based randomisation schedule. Members of the research team do not have access to the randomisation schedule and must contact the holder of the allocation schedule who was "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule will be pre-generated using permuted block randomisation with variable block sizes by an independent researcher.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study employs a mixed-methods design with qualitative and quantitative components. This study uses a semi-structured interview after treatment to address the primary aim of understanding parents’ opinions of the mode of delivery, content and format of the program.

Hypotheses pertaining to the reduction of sleep and mental health problems will be tested using a combination of chi square analyses and hierarchical linear modelling (HLM). Specifically, the binary outcome of sleep problem vs no sleep problem will be examined and reported using chi-square analyses for each assessment occasion. The continuous sleep and mental health outcome measures will be analysed using an intent-to-treat approach with repeated measures, mixed model, HLM, taking time as a within-subjects effect and treatment arm as a between subjects effect.

Power calculations are conservatively based on chi-square tests using ‘sleep problem’ vs ‘no sleep problem’ as the outcome measure for effects between the two conditions. Although we expect a large effect size for sleep problems, we expect a moderate effect for mental health problems. This is a PhD study which aims to recruit 40 families (20 intervention, 20 waitlist).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307819 0
University
Name [1] 307819 0
Griffith University
Country [1] 307819 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
176 Messines Ridge Road,
Mt Gravatt QLD 4122
Country
Australia
Secondary sponsor category [1] 308556 0
None
Name [1] 308556 0
Address [1] 308556 0
Country [1] 308556 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307825 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 307825 0
Office for Research
Level 0, Bray Centre (N54)
Griffith University
170 Kessels Road
Nathan Qld 4111
Ethics committee country [1] 307825 0
Australia
Date submitted for ethics approval [1] 307825 0
01/10/2020
Approval date [1] 307825 0
23/10/2020
Ethics approval number [1] 307825 0
2020/818

Summary
Brief summary
The aim of this study is to a trial a parent-focussed treatment program for sleep problems in young children delivered by videoconference. We will determine whether the sleep program is more effective than waitlist, in reducing sleep, fear and anxiety problems in children, and improving parenting and family outcomes. Furthermore, the program including the delivery mode (video conference) will be evaluated by parent satisfaction ratings as well as a 15-minute telephone interview.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108634 0
A/Prof Caroline Donovan
Address 108634 0
Griffith University Mt Gravatt Campus
School of Applied Psychology
176 Messines Ridge Road, Mt Gravatt QLD 4122
Country 108634 0
Australia
Phone 108634 0
+61 7 3735 3401
Fax 108634 0
Email 108634 0
[email protected]
Contact person for public queries
Name 108635 0
A/Prof Caroline Donovan
Address 108635 0
Griffith University Mt Gravatt Campus
School of Applied Psychology
176 Messines Ridge Road, Mt Gravatt QLD 4122
Country 108635 0
Australia
Phone 108635 0
+61 7 3735 3401
Fax 108635 0
Email 108635 0
[email protected]
Contact person for scientific queries
Name 108636 0
A/Prof Caroline Donovan
Address 108636 0
Griffith University Mt Gravatt Campus
School of Applied Psychology
176 Messines Ridge Road, Mt Gravatt QLD 4122
Country 108636 0
Australia
Phone 108636 0
+61 7 3735 3401
Fax 108636 0
Email 108636 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


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.