Neurodevelopmental Disorders Clinical Trial
— BNBD-NDDOfficial title:
Development, Implementation, and Evaluation of an Internet-based Behavioural Sleep Intervention for Children With NDD and Insomnia
Verified date | April 2022 |
Source | IWK Health Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 218 |
Est. completion date | May 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Dalhousie University | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
IWK Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic Questionnaire to collect Demographic Information | 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. | Baseline | |
Other | Treatment Utilization Questionnaire | 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). | 8 months | |
Other | Client Satisfaction Questionnaire (CSQ-8) to assess Treatment Satisfaction | 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 months | |
Other | Adherence to Protocol based on number of times participants access the intervention site to assess Treatment Integrity | Computer-generated user statistics will be used to assess adherence to protocol to determine the number of times the site was accessed. | 4 months | |
Other | Adherence to Protocol based on length of time participants access the intervention site to assess Treatment Integrity | Computer-generated user statistics will be used to assess adherence to protocol to determine the length of time participants accessed the site. | 4 months | |
Other | Barriers to Treatment Participation Scale (BTPS) to assess Confounding factors | 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. | 4 months | |
Other | Children's Physical Activity Index (CPAI) | The 5 item CPAI measures children's level of physical activity. | 8 months | |
Other | Body Mass Index (BMI) | The BMI measure is used as a measure of obesity of the participant's child. | 8 months | |
Other | Parents Rating of Clinically Significant Improvement (PRCSI) | The PRSCI assesses clinically significant improvement using analogue-scale parental reports. The PRCSI contains 3 items to capture parent's satisfaction with the BNBD intervention.
During follow-up assessments, participants indicate how much their child's sleep problems have improved since they began the program. |
8 months | |
Other | Readiness for Change (RC) | The RC questionnaire is administered to assesses whether participants are mindful and willing to adjust their parenting practices and assessed as a predictor of treatment engagement. | Baseline | |
Other | Bedtime Routines Questionnaire (BRQ) | The BRQ is a 31-item parent-report measure of children's bedtime routine activities, specific to the consistency of the child's weekday and weekend bedtime routines, reactivity to changes in the routine, and frequency of adaptive and maladaptive activities before bedtime. The consistency score is the variable assessed in this study as a predictor for treatment outcome; increased agreement with the use of limit setting strategies and rewards relates to better outcomes in children's sleep. | 4 months | |
Other | Willingness to Pay (WP) | The WP is an author-made questionnaire used to measure participant perception of the value of the intervention. Responses are used to assess the potential for commercialization and identify additional resources that could supplement the intervention. | 4 months | |
Primary | 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 | Sleep Diary | 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, 4-month follow-up and 8 month-post randomization; data will be averaged over the week. | 8 months | |
Secondary | Actigraphy | Actigraphy involves measurement of motor activity using an accelerometer-based device. It provides measures of children's sleep duration, sleep onset and sleep efficiency. | 8 months | |
Secondary | Child Behavior Checklist (CBCL) to assess Child Psychosocial Health | 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 . | 8 months | |
Secondary | Pediatric Quality of Life (Peds-QL) | The Pediatric Quality of Life (Peds-QL) will be used to assess child psychosocial health | 8 months | |
Secondary | Single Item Fatigue Impact Scale (SIFIS) to assess Caregiver Fatigue | 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). | 8 months | |
Secondary | Parenting Scale (PS) to assess Parenting Practices | 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. | 8 months | |
Secondary | Depression Anxiety Stress Scale (DASS-21) to assess Caregiver Psychological Health | 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. | 8 months |
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