Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000633987
Ethics application status
Approved
Date submitted
6/05/2020
Date registered
29/05/2020
Date last updated
4/11/2021
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Dream Changer: A parent-based intervention to reduce childhood nightmares
Scientific title
Parent-based intervention for childhood nightmares: a randomized controlled trial
Secondary ID [1] 301207 0
None
Universal Trial Number (UTN)
U1111-1251-6744
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood nightmares 317356 0
Condition category
Condition code
Mental Health 315462 315462 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'Dream Changer' intervention: Participating parents will be provided with a 'Dream Changer', which is a remote-like device that emits dim light with a push of its button. The 'Dream Changer' is shaped and sized much like a TV remote-control, made out of white plastic. It has one button, that when pushed- lights up a dim (~0.5 lumen) blue light, that shines through a 0.5cm transparent lens surrounding the remote. The 'Dream Changer' also has a vinil 1X1 inch sticker with the words "Dream Changer" and an image of a light blue planet, stars and cloud.
The 'Dream Changer' will be sent to participants via post. Parents will be instructed to provide the following explanation when presenting the 'Dream Changer' to their child: "Sometimes you wake up from a bad dream at night, right? I want to give you something that will help you (present the Dream Changer to the child). This is the ‘Dream Changer’. It is a remote control, like the remote we have for the TV. When you don’t like something on the screen you use the remote to change the channel, right? Now you can do the same thing with your dreams. Dreams are like videos we watch in our sleep- our brain creates them, and we watch them with our eyes shut. From now on you decide which ‘video’ to watch in your sleep. When you get into bed, think about a good dream you’d like to watch in your sleep tonight. And if a bad dream starts screening, use this to change it”.
These instructions will be provided to parents in writing on a single occasion, along with educational information about nightmares in children, and their potential effects on sleep and avoidance behaviors. A link to a short video-clip of a clinical psychologist (with over 15 years experience) explaining these issues and presenting the 'Dream Changer' will additionally be provided to parents. This video clip is designed specifically for the purpose of this study.
As a way of monitoring adherence, parents will report the number of nights in which the child went to sleep with the 'Dream Changer', and number of times the child used it during the previous week. This will be done on two occasions- one per week in the two weeks after providing their child with the 'Dream Changer'.
Parents will be able to keep the 'Dream Changer' for up to 3 months after treatment is completed.
Intervention code [1] 317509 0
Treatment: Other
Intervention code [2] 317708 0
Treatment: Devices
Comparator / control treatment
Waitlist control (Participants in this group will receive treatment 3-weeks after entering the study)
Control group
Active

Outcomes
Primary outcome [1] 323709 0
Child nightmare frequency, as assessed using the Child's Sleep Habits Questionnaire.
Timepoint [1] 323709 0
baseline, 1-week post intervention commencement (primary), 2-weeks post intervention and 3-months post intervention.
Primary outcome [2] 323710 0
Child sleep-wake patterns, as assessed using the Child's Sleep Habits Questionnaire. The following sleep aspects will be examined: (1) sleep onset latency; (2) number of nighttime awakenings; (3) duration of wake after sleep onset; (4) total sleep duration; (5) sleep onset time.
Timepoint [2] 323710 0
baseline, 1-week post intervention commencement (primary) 2-weeks post intervention and 3-months post intervention.
Secondary outcome [1] 382683 0
Child anxiety, as assessed using the Spence Children's Anxiety Scale.
Timepoint [1] 382683 0
baseline, 1-week post intervention commencement, 2-weeks post intervention and 3-months post intervention.
Secondary outcome [2] 382685 0
Parent sleepiness, as assessed using the Epworth Sleepiness Scale.
Timepoint [2] 382685 0
baseline, 1-week post intervention commencement, 2-weeks post intervention and 3-months post intervention.

Eligibility
Key inclusion criteria
Eligible participants will be (1) parents of children aged 3-8 years old with recurrent nightmares (at least 1 per week on average during the past month); (2) aged 18 years or older; (3) residing in Australia.
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
N/A

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)
Yes (central randomization by computer)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Based on previous intervention studies in this field, effect sizes are expected to be moderate. Thus, N=60 participants are expected to yield 80% power. Linear mixed models will be used to assess treatment outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2020
Actual
29/06/2020
Date of last participant enrolment
Anticipated
1/02/2021
Actual
18/01/2021
Date of last data collection
Anticipated
15/02/2021
Actual
26/04/2021
Sample size
Target
60
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305656 0
Commercial sector/Industry
Name [1] 305656 0
InventionCity
Country [1] 305656 0
United States of America
Primary sponsor type
University
Name
Flinders University
Address
Flinders Univeristy
College of Education, Psychology and Social Work
Sturt Rd, Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 306070 0
None
Name [1] 306070 0
Address [1] 306070 0
Country [1] 306070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305940 0
Social and Behavioural Research Ethics Committee, Flinders University
Ethics committee address [1] 305940 0
Social and Behavioural Research Ethics Committee, Flinders University
Sturt Rd, Bedford Park
South Australia 5042
Ethics committee country [1] 305940 0
Australia
Date submitted for ethics approval [1] 305940 0
05/02/2020
Approval date [1] 305940 0
06/04/2020
Ethics approval number [1] 305940 0
8598

Summary
Brief summary
Nightmares and nighttime worries are substantial contributors to decreases in child sleep duration and quality, and have been shown to have a myriad of adverse effects on child development and well-being. As these phenomena are pervasive, there is a critical need to provide parents with simple parenting practices that will help their children cope with nightmares and promote better sleep. This project aims to determine whether parents who provide their children with an imagination-based technique (specifically, a ‘Dream-Changer’ remote) subsequently report fewer child nightmares and improved sleep, compared to parents who do not use this technique. The value of identifying such accessible, straightforward, low-cost interventions to promote child sleep and well-being is of vast value and significance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102142 0
Prof Michael Gradisar
Address 102142 0
Flinders University
Social Sciences North
Sturt Rd, Bedford Park
SA 5042
Country 102142 0
Australia
Phone 102142 0
+61 8 82012324
Fax 102142 0
Email 102142 0
michael.gradisar@flinders.edu.au
Contact person for public queries
Name 102143 0
Michael Gradisar
Address 102143 0
Flinders University
Social Sciences North
Sturt Rd, Bedford Park
SA 5042
Country 102143 0
Australia
Phone 102143 0
+61 8 82012324
Fax 102143 0
Email 102143 0
michael.gradisar@flinders.edu.au
Contact person for scientific queries
Name 102144 0
Michael Gradisar
Address 102144 0
Flinders University
Social Sciences North
Sturt Rd, Bedford Park
SA 5042
Country 102144 0
Australia
Phone 102144 0
+61 8 82012324
Fax 102144 0
Email 102144 0
michael.gradisar@flinders.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseThe "Dream Changer": a randomized controlled trial evaluating the efficacy of a parent-based intervention for childhood nightmares.2022https://dx.doi.org/10.1093/sleep/zsac004
N.B. These documents automatically identified may not have been verified by the study sponsor.