The ABCs of SLEEPING: Effectiveness Study

NCT05072548 | Completed

• 1 other identifier: 38732
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will examine the effectiveness of a mobile applicable intervention called the "ABCs of SLEEPING". This intervention provides parents with prioritized/customized sleep recommendations and a sleep report based on their responses to the "Sleep check-in". This app is evidence-based and developed by sleep researchers and its aim is to provide accessible evidence-based sleep information for parents of children aged 6 to 12 years of age.

Conditions

Sleep Problems; Behavioural Insomnia of Childhood

Keywords

School aged children; Sleep problems; Behavioural insomnia; Smartphone intervention; Behavioural intervention

Outcome Measures

Primary Outcomes (1)

• Children's Sleep Habits Questionnaire (i.e., child sleep habits measure)

  This questionnaire was designed as a sleep screening instrument for school-aged children that yields final scores across eight subscales: bedtime resistance, sleep resistance, parasomnia, sleep disordered breathing, night-wakings, daytime sleepiness, sleep anxiety, and sleep onset delay, as well as a summative score, called the Total Sleep Disturbance score. This is the investigator's primary outcome measure because the ABCs of SLEEPING is aimed at improving children's sleep habits.

  Measured once at pre-test and once at post-test (i.e., 6-week follow up) to examine change in sleep habits.

Secondary Outcomes (4)

• Pediatric Insomnia Severity Index (i.e., pediatric insomnia severity measure)

  Measured once at pre-test and once at post-test (i.e., 6-week follow up) to examine change in pediatric insomnia severity.

• Actigraphy (i.e., sleep onset latency measure).

  Measured for 5-7 days at pre-test, and 5-7 days at post-test (i.e., 6-week follow up) to examine change in sleep onset latency (i.e., objective measures of sleep).

• Sleep Diary

  Measured for 5-7 days at pre-test, and 5-7 days at post-test (i.e., 6-week follow up) to examine change in sleep onset latency and sleep efficiency (i.e., the sleep diary is used alongside actigraphy data as an objective measure of sleep).

• Actigraphy (i.e., sleep efficiency measure).

  Measured for 5-7 days at pre-test, and 5-7 days at post-test (i.e., 6-week follow up) to examine change in sleep efficiency (i.e., objective measures of sleep).

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention arm will receive access to the ABCs of SLEEPING Intervention.

Behavioral: The ABCs of SLEEPING

Control group

NO INTERVENTION

The control group arm does not receive the ABCs of SLEEPING intervention. This arm is free to access other resources while enrolled in the study. After the post-test follow up time point, the control group arm will be able to access the intervention.

Interventions

The ABCs of SLEEPING BEHAVIORAL

The intervention is comprised of three components. The first is a sleep check-in which is a questionnaire that is evidence based and evaluates what areas of sleep parents can work on. The second component is the sleep report which summarizes to the parent what areas they're doing well in (i.e., within the ABCs of SLEEPING mnemonic described above) and what areas they can improve on. The third component of this intervention are the "sleep tips" which are sleep recommendations that are customized based on the identified areas of sleep the parents are suggested to work on.

Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Reside in Canada
• Have internet/computer and smartphone access and an email account for the completion of online questionnaire and for accessing the intervention
• Be comfortable reading and writing in English
• child has at least 1 behaviourally-based sleep problem (i.e., either difficulty falling asleep, staying asleep, and early morning awakenings)

You may not qualify if:

• Child should not have a significant mental or physical health condition (i.e., defined as the child being ambulatory, not hospitalized or in residential care, and able to complete developmentally appropriate daily activities as expected for their age)
• Child should not have a known intrinsic sleep disorder (e.g., sleep apnea)
• Child should not be taking a sleep medication

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Penny Corkum, PhD

  IWK Health Centre; Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be made aware what group they are randomized to (i.e., control or treatment group).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: October 11, 2021
• Study Start: June 10, 2019
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)