Clinical trial NCT02694003: Better Nights, Better Days for Children With Neurodevelopment Disorders
Official title: Development, Implementation, and Evaluation of an Internet-based Behavioural Sleep Intervention for Children With NDD and Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonorganic Insomnia
Neurodevelopmental Disorders
Primary Insomnia
Keywords: Autism Spectrum Disorder (ASD)
Fetal Alcohol Spectrum Disorder (FASD)
Cerebral Palsy (CP)
Attention-Deficit/Hyperactivity Disorder (ADHD)
Behavioural Insomnia
Neurodevelopmental Disorders
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 218
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disorder of Initiating and Maintaining Sleep (DIMS) Score
timeFrame: 8 months
Secondary outcomes:
measure: Sleep Diary
timeFrame: 8 months
measure: Actigraphy
timeFrame: 8 months
measure: Child Behavior Checklist (CBCL) to assess Child Psychosocial Health
timeFrame: 8 months
measure: Pediatric Quality of Life (Peds-QL)
timeFrame: 8 months
measure: Single Item Fatigue Impact Scale (SIFIS) to assess Caregiver Fatigue
timeFrame: 8 months
measure: Parenting Scale (PS) to assess Parenting Practices
timeFrame: 8 months
measure: Depression Anxiety Stress Scale (DASS-21) to assess Caregiver Psychological Health
timeFrame: 8 months
Other outcomes:
measure: Demographic Questionnaire to collect Demographic Information
timeFrame: Baseline
measure: Treatment Utilization Questionnaire
timeFrame: 8 months
measure: Client Satisfaction Questionnaire (CSQ-8) to assess Treatment Satisfaction
timeFrame: 4 months
measure: Adherence to Protocol based on number of times participants access the intervention site to assess Treatment Integrity
timeFrame: 4 months
measure: Adherence to Protocol based on length of time participants access the intervention site to assess Treatment Integrity
timeFrame: 4 months
measure: Barriers to Treatment Participation Scale (BTPS) to assess Confounding factors
timeFrame: 4 months
measure: Children's Physical Activity Index (CPAI)
timeFrame: 8 months
measure: Body Mass Index (BMI)
timeFrame: 8 months
measure: Parents Rating of Clinically Significant Improvement (PRCSI)
timeFrame: 8 months
measure: Readiness for Change (RC)
timeFrame: Baseline
measure: Bedtime Routines Questionnaire (BRQ)
timeFrame: 4 months
measure: Willingness to Pay (WP)
timeFrame: 4 months
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre; Dalhousie University
name: Penny Corkum, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children; University of Toronto
name: Shelly Weiss, MD
role: PRINCIPAL_INVESTIGATOR
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