ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1251-6744

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Childhood nightmares

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

Child nightmare frequency, as assessed using the Child's Sleep Habits Questionnaire.

Timepoint [1]

baseline, 1-week post intervention commencement (primary), 2-weeks post intervention and 3-months post intervention.

Primary outcome [2]

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]

baseline, 1-week post intervention commencement (primary) 2-weeks post intervention and 3-months post intervention.

Secondary outcome [1]

Child anxiety, as assessed using the Spence Children's Anxiety Scale.

Timepoint [1]

baseline, 1-week post intervention commencement, 2-weeks post intervention and 3-months post intervention.

Secondary outcome [2]

Parent sleepiness, as assessed using the Epworth Sleepiness Scale.

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

InventionCity

Address [1]

Invention City Inc.
PO Box 493
East Orleans, MA 02643
USA

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Social and Behavioural Research Ethics Committee, Flinders University

Ethics committee address [1]

Social and Behavioural Research Ethics Committee, Flinders University
Sturt Rd, Bedford Park
South Australia 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/02/2020

Approval date [1]

06/04/2020

Ethics approval number [1]

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

Prof Michael Gradisar

Address

Flinders University
Social Sciences North
Sturt Rd, Bedford Park
SA 5042

Country

Australia

Phone

+61 8 82012324

Fax

michael.gradisar@flinders.edu.au

Contact person for public queries

Name

Michael Gradisar

Address

Flinders University
Social Sciences North
Sturt Rd, Bedford Park
SA 5042

Country

Australia

Phone

+61 8 82012324

Fax

michael.gradisar@flinders.edu.au

Contact person for scientific queries

Name

Michael Gradisar

Address

Flinders University
Social Sciences North
Sturt Rd, Bedford Park
SA 5042

Country

Australia

Phone

+61 8 82012324

Fax

michael.gradisar@flinders.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	The "Dream Changer": a randomized controlled trial evaluating the efficacy of a parent-based intervention for childhood nightmares.	2022	https://dx.doi.org/10.1093/sleep/zsac004

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically