Better Nights, Better Days for Children With Neurodevelopment Disorders (BNBD-NDD)
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|ClinicalTrials.gov Identifier: NCT02694003|
Recruitment Status : Unknown
Verified February 2018 by IWK Health Centre.
Recruitment status was: Not yet recruiting
First Posted : February 29, 2016
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nonorganic Insomnia Neurodevelopmental Disorders Primary Insomnia||Behavioral: BNBD-NDD Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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 .
- 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).
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
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
|Contact: Sydney Dale-McGrath, MAfirstname.lastname@example.org|
|Contact: Becky Petrie, BAemail@example.com|
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3H 2R1|
|Contact: Sydney Dale-McGrath, MA 902-494-5177 firstname.lastname@example.org|
|Principal Investigator: Penny Corkum, PhD|
|Principal Investigator: Shelly Weiss, MD|
|Principal Investigator:||Penny Corkum, PhD||IWK Health Centre; Dalhousie University|
|Principal Investigator:||Shelly Weiss, MD||The Hospital for Sick Children; University of Toronto|