Better Nights, Better Days for Children With Neurodevelopment Disorders

NCT02694003 | Completed DMC

• 1 other identifier: 1024081
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Disorder of Initiating and Maintaining Sleep (DIMS) Score

  Disorder of Initiating and Maintaining Sleep (DIMS) score calculated based on parent-report questionnaire data. DIMS is a measure that captures the degree of severity of sleeping problems, and is calculated using a sum of select questions from the Tayside Children's Sleep Questionnaire (administered to parents of children ages 4-5 years old) or the Sleep Disturbance Scale for Children (administered to parents of children ages 6-12 years old).

  8 months

Secondary Outcomes (7)

• Sleep Diary

  8 months

• Actigraphy

  8 months

• Child Behavior Checklist (CBCL) to assess Child Psychosocial Health

  8 months

• Pediatric Quality of Life (Peds-QL)

  8 months

• Single Item Fatigue Impact Scale (SIFIS) to assess Caregiver Fatigue

  8 months

Other Outcomes (12)

• Demographic Questionnaire to collect Demographic Information

  Baseline

• Treatment Utilization Questionnaire

  8 months

• Client Satisfaction Questionnaire (CSQ-8) to assess Treatment Satisfaction

  4 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: BNBD-NDD Intervention

Usual Care

NO INTERVENTION

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.

Interventions

BNBD-NDD Intervention 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.

Intervention

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• are the primary caregiver of a child aged 4 to 12 years
• live in any province/territory in Canada
• have regular access to a high-speed internet connection and an email account
• fluent in English or French
• have self-reported listening and reading comprehension level of grade 6 or higher
• have a child with ASD, CP, FASD, or ADHD, with level of impairment ranging from mild to moderate, in addition to insomnia

You may not qualify if:

• caregiver wishes to "bed-share" with child
• child has a probable intrinsic sleep disorder (e.g., sleep apnea)
• 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)
• child has a mental health disorder that has required hospitalization or residential care
• child is non-ambulatory
• child experiences enuresis at least 3 times per week that requires parental intervention during the night
• 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)
• 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

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 2R1, Canada

Location

Related Publications (1)

• 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.

  PMID: 37698915 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Neurodevelopmental Disorders; Autism Spectrum Disorder; Fetal Alcohol Spectrum Disorders; Cerebral Palsy; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Child Development Disorders, Pervasive; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Attention Deficit and Disruptive Behavior Disorders

Study Officials

• Penny Corkum, PhD

  IWK Health Centre; Dalhousie University

  PRINCIPAL INVESTIGATOR

• Shelly Weiss, MD

  The Hospital for Sick Children; University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: February 29, 2016
• 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)