Sleep ProblemsNCT05072548
The ABCs of SLEEPING: Effectiveness Study
A study testing The ABCs of SLEEPING in people with Sleep Problems and Behavioural Insomnia of Childhood, run by IWK Health Centre at 1 site in Canada.
Trial 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". Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Problems, Behavioural Insomnia of Childhood
- What is being tested?
- The ABCs of SLEEPING
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2019to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of the ABCs of SLEEPING Mobile Applicable
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.
Read the detailed description
An evidence-based approach to treating sleep problems in school-aged children is to follow a stepped approach where interventions more easily implemented with fewer side effects (i.e., psychoeducation and implementing healthy sleep practices) are implemented first, followed by more involved approaches (i.e., behavioural intervention), and only using those with potential side effects as a final approach (i.e., medication). While there have been interventions developed for all of the above noted approaches, there are practical barriers (e.g., time and cost) as well as system barriers (e.g., healthcare professionals reporting a lack of training, knowledge, and time to provide evidence-based sleep care). Together, these barriers impact the ability of parents to access sleep intervention within this stepped approach. Given the high prevalence of internet use in North America, there is a growing trend for interventions to be adapted to online formats which addresses these accessibility barriers so that these interventions can reach most families with access to the internet. A smartphone app-based mode of intervention delivery is useful for accessibility and convenience reasons (e.g., no time cost for attending program/intervention sessions for busy parents, cost-effectiveness, etc.). Additionally, delivering sleep intervention via a smartphone app has the strong potential for effectiveness as they are delivered in a home setting (i.e., where new intervention practices are to occur). The investigator's research team has developed a smartphone app intervention called "ABCs of SLEEPING" which was initially developed to be a mnemonic to draw attention to the important factors that must be considered for healthy sleep practices for children: 1) age-appropriate bedtimes and wake-times with consistency, 2) schedules and routines, 3) location, 4) no electronics in the bedroom or before bed, 5) exercise and diet, 6) positivity, 7) independence when falling asleep, and 8) needs met during the day, 9) equal great sleep. The ABCs intervention includes three components. The first component is the ABCs of SLEEPING questionnaire that assesses the child's sleep practices using parent's responses to questions within each of the ABCs of SLEEPING healthy sleep practice areas. These responses algorithmically determine the feedback received on the second component, the sleep report card, which provides parents with feedback on each healthy sleep practice area. Feedback is provided based on a star system, with one star denoting the sleep practice area to be high priority (i.e., the healthy sleep practice recommendations are not being met), two stars denoting medium priority (i.e., the healthy sleep practice recommendations are not being fully met), and three stars denoting low priority (i.e., the healthy sleep practice recommendations are being fully met). The third component, the sleep tips, are then organized for the user in terms of priority. Priority is based on the star system described above, in combination with the robustness of the evidence for the healthy sleep recommendation. For example, if one star was received for both use of electronics at night and exercising prior to bed, use of electronics would be prioritized over exercising before bed based on the strength of the extant literature for this recommendation. To date, the ABCs of SLEEPING intervention has undergone evaluation in terms of its usability (i.e., usability, usefulness, desirability, etc.) and feasibility (i.e., acceptability, implementation, and preliminary efficacy). The next step in this research is to evaluate the ABCs of SLEEPING intervention for its effectiveness using increasing control (i.e., a control group and controlling for variables like sleep medication).
This effectiveness trial will be composed of three study periods. The first period is the "pre-test" period where baseline measures of the Children's Sleep Habits Questionnaire, Pediatric Insomnia Severity Index, Bedtime Routines Questionnaire, Actigraph/Sleep Diary, as well as demographics (i.e., measured using a Demographics Questionnaire) are collected. Following this pre-test period, parents will be randomized to either to the treatment or the control group. Parents randomized to the treatment group will receive the ABCs of SLEEPING intervention for a 4-week period. Parents in the intervention group will no longer have access to the intervention after this 4-week period concludes. Parents in the control group are not required to complete any study measures during this time period. Following this "intervention period" is the "post-test" period. During the post-test period, parents will complete again the study's measures (i.e., The Children's Sleep Habits Questionnaire, Pediatric Insomnia Severity Index, Bedtime Routines Questionnaire, and Actigraph/Sleep Diary). After completing the post-test period, the study will conclude. Additionally, parents in the control group will receive the intervention for a 4-week period.
- Conditions
- Sleep Problems, Behavioural Insomnia of Childhood
- Being tested
- The ABCs of SLEEPING
- Keywords
- School aged children, Sleep problems, Behavioural insomnia, Smartphone intervention, Behavioural intervention
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ABCs of SLEEPINGBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm will receive access to the ABCs of SLEEPING Intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
The Pediatric Insomnia Severity Index assesses sleep onset problems using parental report of sleep maintenance problems, daytime sleepiness, and nocturnal sleep duration. This questionnaire will be used to describe the severity of insomnia in this sample, as well as to assess change in insomnia severity.
Measured: 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).
An actigraph is a battery-operated, watch-like device, most often worn on the non-dominant wrist, that collects movement information using accelerometer technology. Previous studies have shown that the commercial software algorithms used to analyze actigraphy data provide valid and reliable estimates of when participants are asleep and awake, as well as a means of assessing sleep quality variables such as sleep latency and duration. For the current study, Philips actigraphs will be used. The participant's child will wear an actigraph for the purposes of collecting objective information about sleep onset latency (how quickly the child falls asleep). Note that actigraphy is used for measuring both sleep onset latency and sleep efficiency. The investigators have described these as two separate outcome measures that are measured using the same tool (i.e., actigraphy).
Measured: 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
This study will utilize a brief 8-item sleep diary to collect parent-reported sleep variables (e.g., "what time was your child down for the night?"). This questionnaire will be utilized to help score actigraphy data by examining corresponding information.
Measured: 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).
An actigraph is a battery-operated, watch-like device, most often worn on the non-dominant wrist, that collects movement information using accelerometer technology. Previous studies have shown that the commercial software algorithms used to analyze actigraphy data provide valid and reliable estimates of when participants are asleep and awake, as well as a means of assessing sleep quality variables such as sleep latency and duration. For the current study, Philips actigraphs will be used. The participant's child will wear an actigraph for the purposes of collecting objective information about sleep efficiency (the percentage of time scored as asleep during the sleep period from the time the child goes to bed to the time the child gets out of bed in the morning). Note that actigraphy is used for measuring both sleep onset latency and sleep efficiency. The investigators have described these as two separate outcome measures that are measured using the same tool (i.e., actigraphy).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start10 Jun 2019
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Penny Corkum, PhD, Principal investigator, IWK Health Centre; Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072548
- Sponsor's protocol ID
- 38732
- Status last verified
- Apr 2025
- First submitted
- 28 Jul 2021
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This trial will be reported at a group level only, not individual participant level.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of the ABCs of SLEEPING Mobile Applicable
- ClinicalTrials.gov ID
- NCT05072548
- Acronym / sponsor ID
- 38732
- Conditions
- Sleep Problems, Behavioural Insomnia of Childhood
- Keywords
- School aged children, Sleep problems, Behavioural insomnia, Smartphone intervention, Behavioural intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An evidence-based approach to treating sleep problems in school-aged children is to follow a stepped approach where interventions more easily implemented with fewer side effects (i.e., psychoeducation and implementing healthy sleep practices) are implemented first, followed by more involved approaches (i.e., behavioural intervention), and only using those with potential side effects as a final approach (i.e., medication). While there have been interventions developed for all of the above noted approaches, there are practical barriers (e.g., time and cost) as well as system barriers (e.g., healthcare professionals reporting a lack of training, knowledge, and time to provide evidence-based sleep care). Together, these barriers impact the ability of parents to access sleep intervention within this stepped approach. Given the high prevalence of internet use in North America, there is a growing trend for interventions to be adapted to online formats which addresses these accessibility barriers so that these interventions can reach most families with access to the internet. A smartphone app-based mode of intervention delivery is useful for accessibility and convenience reasons (e.g., no time cost for attending program/intervention sessions for busy parents, cost-effectiveness, etc.). Additionally, delivering sleep intervention via a smartphone app has the strong potential for effectiveness as they are delivered in a home setting (i.e., where new intervention practices are to occur). The investigator's research team has developed a smartphone app intervention called "ABCs of SLEEPING" which was initially developed to be a mnemonic to draw attention to the important factors that must be considered for healthy sleep practices for children: 1) age-appropriate bedtimes and wake-times with consistency, 2) schedules and routines, 3) location, 4) no electronics in the bedroom or before bed, 5) exercise and diet, 6) positivity, 7) independence when falling asleep, and 8) needs met during the day, 9) equal great sleep. The ABCs intervention includes three components. The first component is the ABCs of SLEEPING questionnaire that assesses the child's sleep practices using parent's responses to questions within each of the ABCs of SLEEPING healthy sleep practice areas. These responses algorithmically determine the feedback received on the second component, the sleep report card, which provides parents with feedback on each healthy sleep practice area. Feedback is provided based on a star system, with one star denoting the sleep practice area to be high priority (i.e., the healthy sleep practice recommendations are not being met), two stars denoting medium priority (i.e., the healthy sleep practice recommendations are not being fully met), and three stars denoting low priority (i.e., the healthy sleep practice recommendations are being fully met). The third component, the sleep tips, are then organized for the user in terms of priority. Priority is based on the star system described above, in combination with the robustness of the evidence for the healthy sleep recommendation. For example, if one star was received for both use of electronics at night and exercising prior to bed, use of electronics would be prioritized over exercising before bed based on the strength of the extant literature for this recommendation. To date, the ABCs of SLEEPING intervention has undergone evaluation in terms of its usability (i.e., usability, usefulness, desirability, etc.) and feasibility (i.e., acceptability, implementation, and preliminary efficacy). The next step in this research is to evaluate the ABCs of SLEEPING intervention for its effectiveness using increasing control (i.e., a control group and controlling for variables like sleep medication).
This effectiveness trial will be composed of three study periods. The first period is the "pre-test" period where baseline measures of the Children's Sleep Habits Questionnaire, Pediatric Insomnia Severity Index, Bedtime Routines Questionnaire, Actigraph/Sleep Diary, as well as demographics (i.e., measured using a Demographics Questionnaire) are collected. Following this pre-test period, parents will be randomized to either to the treatment or the control group. Parents randomized to the treatment group will receive the ABCs of SLEEPING intervention for a 4-week period. Parents in the intervention group will no longer have access to the intervention after this 4-week period concludes. Parents in the control group are not required to complete any study measures during this time period. Following this "intervention period" is the "post-test" period. During the post-test period, parents will complete again the study's measures (i.e., The Children's Sleep Habits Questionnaire, Pediatric Insomnia Severity Index, Bedtime Routines Questionnaire, and Actigraph/Sleep Diary). After completing the post-test period, the study will conclude. Additionally, parents in the control group will receive the intervention for a 4-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: The ABCs of SLEEPINGThe intervention arm will receive access to the ABCs of SLEEPING Intervention. |
| 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The ABCs of SLEEPINGThe 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. | Behavioural | Intervention |
Primary outcome
Children's Sleep Habits Questionnaire (i.e., child sleep habits measure)
Time frame: Measured once at pre-test and once at post-test (i.e., 6-week follow up) to examine change in sleep habits.
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.
4 secondary outcomes
Pediatric Insomnia Severity Index (i.e., pediatric insomnia severity measure)
Time frame: 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).
Time frame: 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
Time frame: 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).
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No. This trial will be reported at a group level only, not individual participant level.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny Corkum, PhD principal investigator
IWK Health Centre; Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The ABCs of SLEEPING in people with Sleep Problems and Behavioural Insomnia of Childhood, run by IWK Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Sleep Habits Questionnaire (i.e., child sleep habits measure) (time frame: Measured once at pre-test and once at post-test (i.e., 6-week follow up) to examine change in sleep habits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.