Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Better Nights, Better Days for Children With Neurodevelopment Disorders (BNBD-NDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02694003
Recruitment Status : Not yet recruiting
First Posted : February 29, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
IWK Health Centre

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.

Condition or disease Intervention/treatment Phase
Nonorganic Insomnia Neurodevelopmental Disorders Primary Insomnia Behavioral: BNBD-NDD Intervention Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development, Implementation, and Evaluation of an Internet-based Behavioural Sleep Intervention for Children With NDD and Insomnia
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Intervention
The intervention arm will receive access to the BNBD-NDD Intervention.
Behavioral: 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.

No Intervention: 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 6-month follow up time point, the usual care arm will be able to access the intervention.



Primary Outcome Measures :
  1. Sleep Diary [ Time Frame: 6 months ]
    Caregivers will record information about their children's sleep (bedtime, sleep onset, final awakening time) and sleep behaviours (frequency and duration of nocturnal awakenings) for a one-week period to measure change at baseline, 3-month follow-up and 6 month-post randomization; data will be averaged over the week.

  2. Actigraphy [ Time Frame: 6 months ]
    Actigraphy involves measurement of motor activity using an accelerometer-based device. It provides measures of children's sleep duration, sleep onset and sleep efficiency.


Secondary Outcome Measures :
  1. Children's Sleep Habits Questionnaire (CSHQ) to asses Children's Sleep Habits [ Time Frame: 6 months ]
    The Children's Sleep Habits Questionnaire (CSHQ) was originally validated for children ages 4 through 10, but has also been used successfully with children as young as 2 years. The CSHQ composite score will be used. The CSHQ has demonstrated internal consistency (0.78), test-retest reliability (r = 0.67 to r = 0.79), and validity. It has been validated for use with children with ASD and FASD, and recommended for use in children with CP.

  2. Child Behavior Checklist (CBCL) to assess Child Psychosocial Health [ Time Frame: 6 months ]
    The age-appropriate version (1.5-5 years or 6-18 years) of the Child Behavior Checklist (CBCL) will be used to assess the child's daytime behavioural, attentional, and emotional functioning. Internalizing (i.e., anxiety, depressive symptoms) and externalizing (i.e., aggression, non-compliance, attention problems) scales will be examined separately. The CBCL has been used in research with NDD populations, including ASD, ADHD, and FASD .

  3. Single Item Fatigue Impact Scale (SIFIS) to assess Caregiver Fatigue [ Time Frame: 6 months ]
    Caregiver daytime fatigue will be assessed using a single-item scale. Caregivers indicate how much fatigue has affected them during the past week, using a 0 to 10 rating scale (where 10 represents severely disabling fatigue).

  4. Depression Anxiety Stress Scale (DASS-21) to assess Caregiver Psychological Health [ Time Frame: 6 months ]
    Caregivers' psychological symptomatology will be assessed by the Depression Anxiety Stress Scale (DASS-21). The DASS-21 has strong internal consistency, test-retest reliability, and overall validity, as well as established clinical cut-offs.

  5. Parenting Scale (PS) to assess Parenting Practices [ Time Frame: 6 months ]
    The Parenting Scale (PS) will be used to assess dysfunctional parental discipline practices. The measure has established test-retest reliability and validity. The Parenting Scale has been validated for caregivers of children with ADHD and been used with caregivers of children with NDD, including ASD.


Other Outcome Measures:
  1. Demographic Questionnaire to collect Demographic Information [ Time Frame: 6 months ]
    Basic demographic information for caregivers (e.g., marital status, educational attainment) and families (e.g., household income, ethnicity, number of siblings) will be assessed using a Demographic Questionnaire comprised of items from the Canadian Census to facilitate comparisons with population data and BNBD data. These data will be collected at Baseline, and changes in family composition will be assessed at the 6-month follow-up.

  2. Services for Children and Adolescents-Parent Interview (SCAPI) to assess Treatment Utilization [ Time Frame: 6 months ]
    Help received by caregivers from health professionals and agencies, as well as changes in treatment status (e.g., medication changes) will be measured by caregivers' reports of health care utilization and co-interventions on a validated measure (Services for Children and Adolescents-Parent Interview).

  3. Client Satisfaction Questionnaire (CSQ-8) to assess Treatment Satisfaction [ Time Frame: 3 months ]
    The investigators will use the treatment satisfaction measure the Client Satisfaction Questionnaire (CSQ-8) for the intervention group only at the 3 month time point. To maximize unbiased reporting, all completed questionnaires will be e-mailed to a research trainee who will not be involved with other aspects of the project.

  4. Adherence to Protocol based on number of times participants access the intervention site to assess Treatment Integrity [ Time Frame: 3 months ]
    Computer-generated user statistics will be used to assess adherence to protocol to determine the number of times the site was accessed.

  5. Adherence to Protocol based on length of time participants access the intervention site to assess Treatment Integrity [ Time Frame: 3 months ]
    Computer-generated user statistics will be used to assess adherence to protocol to determine the length of time participants accessed the site.

  6. Barriers to Treatment Participation Scale (BTPS) to assess Confounding factors [ Time Frame: 3 months ]
    The investigators will assess variables known to affect caregivers' ability to implement treatment, or contribute to treatment termination, using a standardized checklist, the Barriers to Treatment Participation Scale (BTPS) that includes occurrence of critical events (e.g., hospitalization of family member, moving) to evaluate the effects of various variables on treatment outcomes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. are the primary caregiver of a child aged 3 to 10 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 has a functional impairment below the 2nd percentile as determined by a caregiver report measure, the Adaptive Behavior Assessment System, 2nd Edition (ABAS-II)
  7. if 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694003


Contacts
Layout table for location contacts
Contact: Sydney Dale-McGrath, MA 902-494-5177 bnbdndd@dal.ca
Contact: Becky Petrie, BA 902-494-5177 bnbd@dal.ca

Locations
Layout table for location information
Canada, Nova Scotia
Dalhousie University Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2R1
Contact: Sydney Dale-McGrath, MA    902-494-5177    bnbdndd@dal.ca   
Principal Investigator: Penny Corkum, PhD         
Principal Investigator: Shelly Weiss, MD         
Sponsors and Collaborators
IWK Health Centre
Investigators
Layout table for investigator information
Principal Investigator: Penny Corkum, PhD IWK Health Centre; Dalhousie University
Principal Investigator: Shelly Weiss, MD The Hospital for Sick Children; University of Toronto

Layout table for additonal information
Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT02694003     History of Changes
Other Study ID Numbers: 34929
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This trial will be reported at a group level only, not individual participant level.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by IWK Health Centre:
Autism Spectrum Disorder (ASD)
Fetal Alcohol Spectrum Disorder (FASD)
Cerebral Palsy (CP)
Attention-Deficit/Hyperactivity Disorder (ADHD)
Behavioural Insomnia
Neurodevelopmental Disorders

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Sleep Initiation and Maintenance Disorders
Neurodevelopmental Disorders
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders