Better Nights, Better Days for Children With Neurodevelopment Disorders

NCT ID: NCT02694003

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2023-01-10

Brief Summary

More than 90% of children with neurodevelopmental disorders (NDD) experience sleep problems, whereas less than 25% of typically developing children experience sleep problems. Poor sleep can have significant consequences for children's physical and psychosocial health, as well their caregivers' well-being. The impact of sleep problems on daytime functioning is even greater in children with NDD. Although there are a range of factors that may disturb sleep in children with NDD, the most frequent cause of sleep disturbance is behavioural insomnia. There is some evidence that behavioural interventions can be effective in improving sleep in children with NDD. However, this has not been tested through well-designed, large-scale randomized controlled trials (RCTs). Moreover, there are a number of significant barriers to access for insomnia treatment for children; most importantly, sleep interventions are often only provided by specialists, limiting access to treatment services. Instead, behavioural insomnia is often treated with advice about sleep hygiene and with the supplement melatonin, which is, at best, a short-term solution. The investigators, an interdisciplinary team of researchers, will develop and evaluate the effectiveness of an online sleep intervention that will be widely accessible and sustainable and will have the potential to dramatically improve the health of children with NDD and their families.

Detailed Description

The purpose of the study is to develop and evaluate a web-based intervention for insomnia among children with neurodevelopmental disabilities (NDD), including Autism Spectrum Disorder (ASD), Fetal Alcohol Spectrum Disorder (FASD), Cerebral Palsy (CP), and Attention-Deficit/Hyperactivity Disorder (ADHD). Using the internet to deliver an intervention program for insomnia in children will address access barriers and provide evidence-based treatment to large numbers of children with NDD.

This study will adapt the Better Nights, Better Days (BNBD) e-intervention that was developed for typically developing children ages 1-10 years. The adaptation of BNBD will be led by a team of experts in the fields of sleep in children with NDD, including ASD, FASD, CP, and ADHD. The adaption will focus on behaviours that pose challenges to implementation of the evidence-based sleep intervention strategies (e.g., anxiety, parental stress, sensory sensitivities, language impairments, attention difficulties, etc.), rather than disorder-specific symptoms. The finalized intervention is tailored for primary caregives of children between the ages of 4-12 years, with mild to moderate NDD impairment.

The effectiveness of this intervention in improving children's sleep and daytime functioning, as well as secondary effects on the well-being of caregivers, will be evaluated through a randomized controlled trial (RCT). A parallel-design RCT (one per diagnostic group) will be conducted to determine if the web-based sleep intervention for NDD improves children's sleep and is associated with improved psychosocial outcomes for children and their caregivers.

This study is comprised of a development phase and an RCT phase.

Phase 1: Adaptation of web-based intervention and usability testing. A 3-step process will be used to adapt the BNBD e-intervention for use by caregivers of children with NDD.

Step 1: Development of modifications based on team lead input and literature reviews, with the objective to identify specific adaptations for sleep interventions. The investigators will conduct a Delphi study to gain consensus from leading experts on the most appropriate modifications.

Step 2: Modification of the BNBD program. The investigators will work with Velsoft Training Materials Inc. to adapt the intervention for caregivers of children with NDD. Modifications will include changes to the information already included in BNBD, and addition of informational and videos.

Step 3: Usability study with experts and caregivers. The investigators will evaluate the e-intervention on 6 dimensions: usable, credible, accessible, desirable, useful, and valuable. The investigators will obtain participants' perceptions of whether the caregivers will be well supported by this e-intervention, and how to incorporate additional supports. Participants will be 5 health care professionals who work with children with NDD, and 3 caregivers for each NDD group, for a maximum sample of 17.

Phase 2: RCT of the BNBD-NDD Sleep Intervention. In Phase 2, the investigators will evaluate the effectiveness of the web-based intervention for insomnia in 4 to 12-year-olds with NDD. Assessments will be conducted at Baseline and at 4 and 8 months post-randomization. The primary objective is to assess the intervention's immediate impact (Baseline vs. 4 months) on children's sleep. Th secondary objective is to evaluate longer-term impact (Baseline, 4, 8 months) on children's sleep, as well as the longer-term impact on child and caregiver psychosocial health outcomes.

Research Design. Investigators will use a RCT design, with a pragmatic trial approach, to evaluate the effectiveness of the intervention, adhering to CONSORT 2010 guidelines. The investigators will conduct a pragmatic, single-site (with national recruitment) RCT, stratified by diagnostic group. Participants (primary caregivers of children ages 4 to 12 years with insomnia and mild to moderate NDD) will be assigned to Intervention or Usual Care based on a 1-to-1 allocation. The primary objective is to assess whether the intervention improves children' sleep within each group at 4 months and is this improved sleep maintained at the long-term follow-up (8 month assessment). Secondary objectives are to determine whether the intervention results in similar improvements in insomnia symptoms in each of the four NDD diagnostic groups and the intervention's impact on child and caregiver psychosocial health.

Randomization. After Baseline caregivers will be randomized to usual care or internet-based sleep intervention (BNBD-NDD). The usual care group may access other interventions. They will be given access to BNBD-NDD after all follow-up assessments. Caregivers in the intervention group will also be allowed to access other interventions. The investigators will use block-randomized stratification for each of the 4 diagnostic groups. A staff member (not affiliated with the project) will prepare computer-generated block randomization.

Participants. The investigators will recruit 200 eligible participants to have 100 caregivers complete the post-treatment (4 month) assessment. Given the likelihood of overlap in diagnoses across groups, participants will be enrolled based on their primary and most impairing disorder. The intervention will be designed for children with mild-to-moderate disabilities, as it is expected that children with severe neurologic disease will not benefit from this type of intervention.

Screening Assessment. Caregivers will be asked questions through an online screening instrument to assess whether their child meets the study's inclusion criteria and does not meet any of the exclusion criteria. To determine if the child has behavioural insomnia, criteria outlined by Richman and modified by Anders and Dahl, which are consistent with the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) insomnia criteria, will be used. To determine if the child may have sleep apnea (an exclusion item), caregivers will complete the Pediatric Sleep Questionnaire (PSQ).

Baseline and Outcome Assessments. Assessments will be conducted at Baseline and at 4 and 8 months post-randomization for all participants. A research assistant will email caregivers at the appropriate time requesting that they complete the assessment, and will follow up by email or telephone to answer questions and encourage completion of forms. The primary outcome measure used to evaluate the impact of the intervention on children's sleep is the DIMS score which will be calculated based on parent-report sleep questionnaire data. Secondary outcomes will examine change in sleep and psychosocial health, and parent's psychosocial health. The outcome measures of change will include measures of children's sleep and psychosocial health, as well as measures of parents' psychosocial health, and exploratory questionnaires examining how the intervention works.

Conditions

Nonorganic Insomnia; Neurodevelopmental Disorders; Primary Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

The intervention arm will receive access to the BNBD-NDD Intervention.

Group Type: EXPERIMENTAL

BNBD-NDD Intervention

Intervention Type: BEHAVIORAL

The intervention comprises 5 sessions, consisting of educational materials followed by interactive activities, designed to facilitate the successful application of the behavioural strategies. Clinicians and caregivers share tips and recommendations about implementing the strategies, providing modelling and emotional/social support, through supplemental videos. Caregivers complete daily internet sleep diaries that track sleep-related variables and patterns, associations between changes in caregivers' behaviour and children's sleep, and associations between changes in children's sleep and their daytime functioning. At the end of each session, caregivers receive a personalized plan for the week, linking relevant session strategies to caregivers' goals for their children's sleep.

Usual Care

The usual care arm does not receive the BNBD-NDD intervention. This arm is free to access other resources while enrolled in the study. After the 8-month follow up time point, the usual care arm will be able to access the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BNBD-NDD Intervention

The intervention comprises 5 sessions, consisting of educational materials followed by interactive activities, designed to facilitate the successful application of the behavioural strategies. Clinicians and caregivers share tips and recommendations about implementing the strategies, providing modelling and emotional/social support, through supplemental videos. Caregivers complete daily internet sleep diaries that track sleep-related variables and patterns, associations between changes in caregivers' behaviour and children's sleep, and associations between changes in children's sleep and their daytime functioning. At the end of each session, caregivers receive a personalized plan for the week, linking relevant session strategies to caregivers' goals for their children's sleep.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. are the primary caregiver of a child aged 4 to 12 years

2. live in any province/territory in Canada

3. have regular access to a high-speed internet connection and an email account

4. fluent in English or French

5. have self-reported listening and reading comprehension level of grade 6 or higher

6. have a child with ASD, CP, FASD, or ADHD, with level of impairment ranging from mild to moderate, in addition to insomnia

Exclusion Criteria

1. caregiver wishes to "bed-share" with child

2. child has a probable intrinsic sleep disorder (e.g., sleep apnea)

3. child has a significant medical disorder that interferes with sleep (e.g., nighttime asthma attacks, tube-feeding, severe developmental disability affecting sensory systems such as vision)

4. child has a mental health disorder that has required hospitalization or residential care

5. child is non-ambulatory

6. child experiences enuresis at least 3 times per week that requires parental intervention during the night

7. child has a functional impairment below the 2nd percentile as determined by a caregiver report measure, the Adaptive Behavior Assessment System, 2nd Edition (ABAS-II)

8. child is currently being treated with anti-epileptic and/or psychotropic medications (e.g., stimulant medication for ADHD) and the medication or dose is not stable and/or expected to change within 6 months

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IWK Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Penny Corkum, PhD

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre; Dalhousie University

Shelly Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children; University of Toronto

Locations

Dalhousie University

Halifax, Nova Scotia, Canada

Countries

Canada

References

Jia XY, Andreou P, Brown C, Constantin E, Godbout R, Hanlon-Dearman A, Ipsiroglu O, Reid G, Shea S, Smith IM, Zwicker JD, Weiss SK, Corkum P. An eHealth Program for Insomnia in Children With Neurodevelopmental Disorders (Better Nights, Better Days): Protocol for an Economic Evaluation of a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 12;12:e46735. doi: 10.2196/46735.

Reference Type: DERIVED

PMID: 37698915 (View on PubMed)

Other Identifiers

1024081

Identifier Type: -

Identifier Source: org_study_id