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Better Nights, Better Days for Typically Developing Children (BNBD)

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ClinicalTrials.gov Identifier: NCT02243501
Recruitment Status : Unknown
Verified March 2017 by IWK Health Centre.
Recruitment status was:  Recruiting
First Posted : September 18, 2014
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
IWK Health Centre

Brief Summary:

Up to 25% of children suffer from sleep problems categorized as "insomnia": difficulty settling, falling asleep, and staying asleep. This leads to daytime sleepiness and negatively effects behaviour, mood, and academic performance. It also has negative effects on primary caregiver's sleep and their daytime functioning. Despite robust evidence supporting the efficacy of behavioural treatments for insomnia in children, very few receive these treatments. The most common treatment for insomnia in children is medication. This pattern of care is troubling because there are no approved medications for insomnia in children, and there are concerns about the safety and side effects of these medications. One of the primary reasons for the low rate of evidence-based treatment is the shortage of available treatment resources for both parents and health care providers.

When evidence-based treatments are available, they are usually provided in a traditional service delivery framework. These traditional approaches are often very difficult for parents to access due to scheduling conflicts, incidental costs, and travel difficulties. Thus, there is a critical need for access to effective interventions focused on insomnia for children, and increased knowledge for parents and health care providers about appropriate treatments for insomnia.

The Better Nights, Better Days (BNBD) program will provide a potential solution to one of the most common treatment barriers: access to care. BNBD will provide a readily accessible distance treatment via the internet, to increase access to evidence-based care for insomnia in typically developing children aged 1 to 10. BNBD was developed based on evidence-based programs and extant literature. The investigators will conduct a randomized controlled trial (RCT) in which participants (primary caregivers of children ages 1 to 10 years with insomnia) will be assigned to Intervention or Usual Care based on a 1-to-1 allocation. The effects of this behavioural sleep intervention will be assessed at 4 and 8 months post baseline assessment. Assessment will include both sleep and daytime functioning of the children, and daytime functioning of their caregivers.

This study aligns with the recognized need to more rapidly transfer new scientific knowledge to improve patient care and population health, and targets the validation of new treatment delivery models to increase availability of effective treatment.


Condition or disease Intervention/treatment Phase
Nonorganic Insomnia Primary Insomnia Behavioral: Intervention Group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Better Nights, Better Days: Improving Psychosocial Health Outcomes in Children With Behavioural Insomnia
Study Start Date : September 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: Intervention Group
The Intervention Group receives access to the BNBD intervention, and can access alternative resources while enrolled in the study. The BNBD intervention for caregivers of children 1 to 10 years with insomnia is a self-guided program delivered online. The intervention is conceptually consistent across age groups. Interactive and personalized content and evidence-based strategies are incorporated: sleep education, positive routines, faded bedtime with response cost, sleep restriction, extinction/graduated extinction, stimulus fading, and scheduled awakenings. BNBD includes five sessions available sequentially: Sleep Information; Healthy Sleep Practices; Settling to Sleep; Going Back to Sleep; Looking Back and Ahead. The completion time of the intervention will range from 5-10 weeks.
Behavioral: Intervention Group
The BNBD intervention for caregivers of children 1 to 10 years with insomnia is a self-guided program delivered online. The intervention is conceptually consistent across age groups. Interactive and personalized content and evidence-based strategies are incorporated: sleep education, positive routines, faded bedtime with response cost, sleep restriction, extinction/graduated extinction, stimulus fading, and scheduled awakenings. BNBD includes five sessions available sequentially: Sleep Information; Healthy Sleep Practices; Settling to Sleep; Going Back to Sleep; Looking Back and Ahead. The completion time of the intervention will range from 5-10 weeks.
Other Name: Better Nights, Better Days

No Intervention: Usual Care Group
The Usual Care Group will receive no treatment until after the 8 month follow-up assessment. The Usual Care Group can access alternative resources and additional programs and services while enrolled in the study.



Primary Outcome Measures :
  1. Change in Sleep Efficiency and Onset Latency from Baseline to 8 Month Follow-up with Actigraphy [ Time Frame: 8 months ]
    Actigraphy involves measurement of motor activity using an accelerometer-based, battery-operated device. The investigators will use actigraphy to collect information about changes in children's sleep efficiency (captured from lights out to awakening), sleep onset, total sleep time, and night wakings from baseline to 4 month and 8 month follow-up. Actigraphy data have been shown to be highly concordant with polysomnographic (PSG) data for identifying sleep and waking (85-90%) and to distinguish effectively between sleep-disturbed children and controls. The investigators will use Philps Respironics Actiwatch 2 actigraphs. Actigraphy data will be collected for a one week period at baseline, and 4 months and 8 months post randomization. Participants are instructed to ensure their child wears their actigraph during the 7 days of Sleep Diary collection.

  2. Change in Sleep Efficiency and Onset Latency from Baseline to 8 Month Follow-up with Sleep Diary [ Time Frame: 8 months ]
    Sleep Diaries will be used to document sleep variables over a number of days/nights. A composite score will capture bedtime resistance, difficulties falling asleep and night wakings, as these are the key features of insomnia in children. Parents record information about their children's sleep and sleep behaviours for a one week. The Sleep Diary contains 25 items specifically measuring; sleep duration, night time sleep duration, daytime sleep duration, sleep onset latency, bedtime, wake time, presence and frequency of night awakening, and the presence and frequency of bedtime resistance. Sleep Diaries also provide a measure of time spent in bed extracted from the time the light was turned off ("Down for the night") to the time lights were turned on ("Up for the day"). Sleep Diaries are administered to participants at the 3 assessment periods to assess change over baseline to 4 month and 8 month follow-up. Sleep diaries have demonstrated good face validity and high internal consistency.


Secondary Outcome Measures :
  1. Tayside Children's Sleep Questionnaire (TCSQ) [ Time Frame: 8 months ]
    Two questionnaires will be used to assess children's sleep / insomnia, depending on the age of the child, at baseline, 4 month and 8 month assessment periods. The Tayside Children's Sleep Questionnaire (TCSQ) consists of 10 items and will be used to measure insomnia symptoms in children aged 1-5 years. Only the first 9 items are used for scoring, and the last item is included to assess how parents view their child's sleep problem, but is excluded from data analysis. The TCSQ has been validated for its use to accurately measure sleep problems.

  2. Pediatric Quality of Life (Peds-QL) [ Time Frame: 8 months ]
    The Pediatric Quality of Life (Peds-QL) questionnaire is used to assess children's physical and psychosocial health at baseline, 4 month and 8 month assessment periods. The participant will complete the form for ages 2-4, 5-7, or 8-12. The Peds-QL is a validated, 23-item modular tool designed to measure health related quality of life (HRQoL) in children and adolescents across 4 domains: physical, emotion, social and school functioning. The questionnaire uses a Likert Scale anchored 0 "never" to 4 "almost always", with reverse-scored answers linearly transformed to a 0-100 scale, with higher scores reflecting higher health related quality of life. The cut-off score assigned to physical health is any value 1 SD below the population sample mean, and this is also applied to psychosocial health.

  3. Child Behaviour Checklist (CBCL) [ Time Frame: 8 months ]
    The Child Behavior Checklist (CBCL) for ages 1 ½-5 and 6-18 will be used to assess the child's daytime functioning and psychosocial health at the three assessment periods. CBCL/1 ½-5 responses are scored and summed across subscales (Emotionally Reactive, Anxious/Depressed, Somatic Complaints, Withdrawn, Sleep Problems, Attention Problems, Aggressive Behaviour), combined into "internalizing" and "externalizing", and compared to a normative sample indicating the child's behaviour falling within "normal" limits, "borderline clinical", or "clinical". CBCL/6-18 responses are scored and summed across subscales (Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Rule-breaking Behaviour and Aggressive Behaviour), grouped into either internalizing or externalizing factors with total scores, compared to a normative sample indicating where the child's behaviour falls. The CBCL is psychometrically sound.

  4. Teacher Report Form (TRF) [ Time Frame: 8 months ]
    The Caregiver Teacher Report Form (C-TRF) for children 1 ½ to 5 and Teacher Report Form (TRF) 6-18 is used to assess children's daytime functioning and psychosocial health, obtained from an informant to validate parent reports. The forms received by teachers are dependent on the child's age. The TRF measures a child's adaptive functioning and behavioural problems with 100 items on a 3-point Likert-scale anchored from 0 "not true" to 2 "very true or often true", with the added textboxes for qualitative feedback. Both TRFs are optional measures that participants may forward to their child's teachers, and are administered at baseline, 4 months and 8-months follow up. The TRF has demonstrated good psychometric properties, high test-retest reliability and internal consistency.

  5. Single Item Fatigue Impact Scale (SIFIS) [ Time Frame: 8 months ]
    The SIFIS is a single item that measures the severity of fatigue on caregivers. Responses are recorded on a Likert-scale anchored from 0 "none" to 10 "a severely disabling effect". Participants receive the SIFIS at baseline, 4 and 8 month assessment periods. The SIFIS was adapted from Chan and colleagues' (2003) 40-item Fatigue Impact Scale, a measure with sound psychometric properties, demonstrating high internal consistency and the adequate correlations between each item's rating and the summed ordinal ratings of the remaining items, high construct validity and responsiveness.

  6. Depression Anxiety Stress Scale (DASS-21) [ Time Frame: 8 months ]
    The Depression Anxiety and Stress Scale (DASS-21) is used to measure self-reported parent distress. Using 21 items, participants indicate to what extent they have experienced certain mental health disorder symptoms in the past month. Items are anchored from 0 "did not apply to me at all" to 3 "applied to me very much or most of the time. Responses are scored into three subscales: depression, anxiety and stress. These subscales are combined to obtain a measure of general stress, which is the variable that used in this study. The DASS-21 has been validated for its use to measure parent distress in a community, nonclinical sample with strong internal consistency. Concurrent validity was also validated, and the DASS-21 also demonstrates high sensitivity to effects of parent-focused interventions.

  7. Parenting Scale (PS) [ Time Frame: 8 months ]
    The Parenting Scale (PS) is used to measure dysfunctional parenting practices consisting of 30 items. This rating scale was designed to measure dysfunctional parenting across three stable factors; laxness, over reactivity, and verbosity. Participants are instructed to select a circle on a visual analogue scale to identify to what extent they engage in certain parenting practices (e.g. giving child several reminders/warnings as opposed to one reminder/warning). The measure has established test reliability and validity.

  8. Sleep Disturbance Scale for Children (SDSC) [ Time Frame: 8 months ]
    Two questionnaires will be used to assess children's sleep / insomnia, depending on the age of the child, at baseline, 4 month and 8 month assessment periods. The Sleep Disturbance Scale for Children (SDSC) will be used to measure insomnia in children aged 6-10. The SDSC will be used to measure initiation and maintenance of sleep. The SDSC has been validated with high sensitivity specificity, and reliability coefficients.


Other Outcome Measures:
  1. Demographic Questionnaire (DQ) [ Time Frame: 8 months ]
    A Demographic Questionnaire (DQ) is used to collect basic demographic information of the participant, the spouse/partner of the participant (if applicable), and the child of the participant. 29 items were compiled from the format of the Canadian Consensus, and the National Longitudinal Survey of Children and Youth (2011). Questions pertain to the age, sex, number of adults living in the home, relationship to the child participating, marital status, ethnic or cultural heritage, highest level of education completed, employment status, work hours, job position, household income, if their spouse/partner live in their home (if applicable), and their spouse/partner's relationship with the participants' child. If applicable, the same questions are asked about the caregiver's spouse/partner and their child. The information collected will be used to describe the sample and will allow us to determine the representativeness of the sample to the Canadian population.

  2. Children's Physical Activity Index (PAI) [ Time Frame: 8 months ]
    The Children's Physical Activity Index CPAI is adapted from the Children's Physical Activity Questionnaire from the Canadian Health Measures Survey (2007) and is used to measure the child's physical activity levels. Participants will receive the CPAI at baseline and 8 month follow-up. When the CPAI is administered, participants will be asked to provide responses to questions aimed at understanding the child's levels of activity and/or inactivity. Response options vary from 5-8 options given, ranging from "never" engaging in a particular activity (either related to activity or inactivity) or "always".

  3. Body Mass Index (BMI) [ Time Frame: 8 months ]
    Body Mass Index (BMI) is collected to determine the physical fitness of the child. BMI will be calculated using The Dieticians of Canada BMI calculator (2015) for children and teens. After the BMI is calculated, percentile charts are calculated. BMI is measured at baseline and 8 month follow-up. Participants are instructed to use a measuring tape and scale to obtain accurate measurements for the height, weight and waist circumference of their child. Participants then provide the exact height, weight, waist circumference, and BMI score. Reference for these instructions were adapted from The Dieticians of Canada BMI calculator website (2015).

  4. Parenting Rating of Clinical Significant Improvement (PRCSI) [ Time Frame: 8 months ]
    The Parents Rating of Clinically Significant Improvement (PRCSI) is used to assess parents' percentage of satisfaction with the intervention progress. The PRCSI was adapted from Montgomery, Stores and Wiggs (2004) to be appropriate for measuring clinically significant improvement using analogue scale self-reports. The PRCSI contains 3 items requiring parents to use an analogue scale to record their satisfaction responses and is administered at baseline, 4 month and 8 month follow-up. This measure is also completed by parents in the Intervention Group prior to each intervention session.

  5. Treatment Utilization (TU) [ Time Frame: 4 months ]
    The Treatment Utilization (TU) questionnaire was adapted from The Parenting Matters Program. It measures the extent to which parents utilize treatment resources (i.e. family physicians). This is a predictor of treatment success and the responses is used to assess the need for treatment intervention. The TU includes 27 items divided into 8 item categories: family physician, pediatrician, other person or place for regular health care, urgent care and emergency room, specialized health services, cost, medications, and other sources of help or advice. The TU is administered at the baseline, 4 and 8 month follow-up.

  6. Willingness to Pay (WP) [ Time Frame: 4 months ]
    The Willingness to Pay (WP) questionnaire will be used to assess participants' perceptions of the value of the program. The WP is administered at baseline and only administered to those in the Intervention Group at 4 month follow-up.

  7. Barriers to Treatment Participation Scale (BTPS) [ Time Frame: 4 months ]
    The Barriers to Treatment Participation Scale (BTPS) is a 12 item questionnaire used to assess participants' experience of obstacles or barriers to participating in their children's treatment, treatment demands or issues, and perceived relevance of treatment. Items are anchored on a 5-point Likert-scale that ranges from 1 "never a problem" to 5 "very often a problem". Previous studies have demonstrated adequate internal consistency reliability. The BTPS will be administered to the Intervention Group at the 4 month follow-up.

  8. Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 4 months ]
    The Client Satisfaction Questionnaire (CSQ-8) is used to measure participant satisfaction with the BNBD intervention. The CSQ-8 is an 8 item measure that is widely used in primary care and mental health treatment and measures satisfaction using a 4-point Likert-scale ranging from 1 being "No, definitely not" to 4 "yes, definitely" in terms of the participant satisfaction. The CSQ-8 is administered to participants receiving the intervention at 4 months follow-up. An overall score for the CQS-8 is produced by summing all item responses producing scores ranging from 8 to 32, with higher values indicating higher satisfaction. The CSQ-8 is a well-established measure for satisfaction with an established internal consistency.

  9. Readiness for Change (RC) [ Time Frame: Baseline ]
    The Readiness for Change (RC) questionnaire assesses whether participants are mindful and willing to adjust their parenting practices. This is used as a predictor of treatment engagement. Several studies have utilized the RC measure in the context of parenting successfully to predict parent commitment to treatment. Participants are instructed to record their responses on a 6-point scale ranging from "strongly disagree" to "strongly agree" with the option to also provide the response "does not apply". The RC is administered at baseline.

  10. Bedtime Routines Questionnaire (BRQ [ Time Frame: 4 months ]
    The Bedtime Routines Questionnaire (BRQ) is used to measure bedtime routine activities using 31 items. This questionnaire provides information about how the participants' child goes to bed during weekdays and weekends. Responses are measured on a 5-point frequency scale ranging from 1 "almost never" to 5 "nearly always". BRQ responses are good predictors for treatment outcome, and increased agreement with the use of limit setting strategies and rewards related to better outcomes in the child's sleep. The BRQ has demonstrated strong psychometric properties. It has an acceptable to excellent internal consistency.



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.


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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Potential participants must meet the following criteria to be eligible to participate in the study:

  1. Primary caregiver of a child aged 1 to 10 years.
  2. Live in any province or territory in Canada.
  3. Have regular access to high speed internet connection and an email account.
  4. Comfortable communicating in English or French for day-to-day tasks (e.g., listening to the news on the radio or watching TV, reading books, magazines, etc.).
  5. Child has insomnia, defined as having Sleep Onset Disturbance. For Sleep Onset Disturbance, child must meet two of the following three criteria. These episodes must have been occurring for at least one month:

1. More than three reunions for 12-24 month olds/more than two reunions for >24 month olds that occur two or more nights per week 2. 30 or more minutes to fall asleep for 12-24 month olds/20 or more minutes to fall asleep for >24 month olds 3. Parent remains in room for sleep onset for two or more nights per week

Exclusion Criteria:

Potential participants who meet any of the following criteria are not eligible to participate in the study:

  1. Parent wishes to "bed-share" with his/her child.
  2. Child has a probable intrinsic sleep disorder (e.g., sleep apnea) as assessed using the Pediatric Sleep Questionnaire (PSQ).
  3. Child has a significant medical disorder that interferes with sleep (e.g., asthma attacks during night, tube feeding, non-ambulatory, severe developmental disability affecting sensory systems such as vision).
  4. Child has a mental health disorder that has required hospitalization or residential care and/or current use of psychotropic medications which are known to interfere with sleep (e.g., stimulant medication for ADHD).

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): NCT02243501


Contacts
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Contact: Sydney Dale-McGrath, MA 902-494-5177 bnbd@dal.ca
Contact: Sydney Dale-McGrath, MA 902-494-5177 bnbdndd@dal.ca

Locations
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Canada, Nova Scotia
Dalhousie University Recruiting
Halifax, Nova Scotia, Canada, B3H 2R1
Contact: Becky Petrie, BA    902-494-5177    bnbd@dal.ca   
Principal Investigator: Penny V Corkum, PhD         
Sponsors and Collaborators
IWK Health Centre
Investigators
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Principal Investigator: Penny V Corkum, PhD Dalhousie University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT02243501     History of Changes
Other Study ID Numbers: 228586
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders