Clinical trial NCT02243501: Better Nights, Better Days for Typically Developing Children
Official title: Better Nights, Better Days: Improving Psychosocial Health Outcomes in Children With Behavioural Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonorganic Insomnia
Primary Insomnia
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 534
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Rationale:

Evidence demonstrates that behavioural interventions should be the first line of treatment for children with insomnia, but this is not typically the case. Evidence-based behavioural intervention protocols are not readily available for clinical use, and their lack of implementation indicates inadequate knowledge translation. When evidence-based treatments are available, they are usually provided in a traditional service delivery framework (i.e., face-to-face therapy, small group therapy). 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 bridge this gap as we will provide a potential solution to one of the most common treatment barriers, access to care.

Intervention:

The BNBD intervention for children aged 1 to 10 years with insomnia is a bilingual, self-guided program delivered online. The intervention incorporates evidence-based strategies, including sleep education, positive routines, faded bedtime with response cost, sleep restriction, extinction/graduated extinction, stimulus fading, and scheduled awakenings. The intervention is comprised of five sessions made available sequentially to participants. The completion time of the intervention will range from 5-10 weeks. Each session will provide factual information to parents, strategies for implementation of best practices to address sleep problems, and access to additional help and advice. There is also a "Reward Centre" where parents can learn how to use reinforcement for children (e.g., sticker charts) to help support the implementation of these sleep intervention strategies. Participants complete a short Sleep Diary for a minimum of 5 days for each session throughout this intervention so that they can receive feedback on their progress. The intervention delivers the interactive, personalized cognitive and behavioural change strategies accessed through participants' desktops, laptops, tablets and smartphones. The program can be used at a time that is convenient for the participants, removing barriers to care and providing services in the comfort and privacy of their own homes.

Objectives and Hypotheses:

The study will evaluate the effectiveness of the BNBD online intervention for insomnia in children 1-10 years of age. The primary objective is to assess the immediate impact (Baseline vs. 4 month) of the intervention on children's sleep. The two hypotheses for the primary outcomes are:

1. Improvements in sleep efficiency calculated using actigraphy data in the Intervention Group compared with the Usual Care Group, and
2. Improvements in sleep efficiency calculated using Sleep Diary data in the Intervention Group compared with the Usual Care Group

The secondary objectives are: a) to evaluate the longer-term impact (baseline, 4, 8 months) on children's sleep and psychosocial health and, b) to examine the impact on parent daytime fatigue and psychosocial health outcomes. The four hypotheses of the secondary outcomes are:

1. Children in the Intervention Group will show improvement compared to children in the Usual Care Group at the two follow-up time points in their symptoms of insomnia based on improvements in sleep efficiency calculated using actigraphy and Sleep Diary data in the Intervention group compared with the Usual Care group.
2. Children in the Intervention Group will show improvement compared to children in the Usual Care Group at the two follow-up time points in their symptoms of insomnia based on the total score from the Behavioural Insomnia Questionnaire (BIQ) and Tayside Children's Sleep Questionnaire (TCSQ; toddler and pre-schoolers) / Sleep Disturbance Scale for Children (SDSC; school-age).
3. Children in the Intervention group, compared to children in the Usual Care Group, will show improved psychosocial health based on the internalizing and externalizing total scores from the Child Behaviour Checklist (CBCL/1 ½-5 and CBCL/6-18) and the total score from the Pediatric Quality of Life (Peds- QL).
4. Parents randomized to the Intervention Group, compared to parents randomized to the Usual Care group, will show at all follow-up time points:

1.Decreased daytime fatigue based on the Single Item Fatigue Impact Scale (SIFIS) 2.Improved psychosocial health as assessed by the total score of the Depression, Anxiety and Stress Scales (DASS-21) 3.Improved parenting strategies as assessed by the total score of the Parenting Scale (PS)

Exploratory analyses will examine age effects, the impact of the intervention on children's physical health, as well as process-level evaluation and implementation questions, exploring how BNBD works (e.g., changes in specific sleep behaviours such as bedtime routines, and predictors of treatment success).

Study Design:

The study is a two-arm Randomized Controlled Tiral (RCT) design, using 1-to-1 allocation, comparing participants assigned to receive either the BNBD online program for parents (Intervention Group) or the control group (Usual Care Group) who will not receive the intervention. The intervention will be delivered across Canada. The study will be coordinated through Corkum LABS at Dalhousie University.

Randomization will be used to minimize bias in the assignment of participants to either group, to increase the likelihood that known and unknown participant attributes (e.g., demographic and baseline characteristics) are evenly balanced, and to enhance the validity of statistical comparisons across groups.

Participants will be stratified at randomization by three age groups (Toddler, Pre-School, School-Aged) and two primary languages (English and French). Targets will be set for each variable - 1/3 of sample in each age group and 20% of sample French speaking, modelling the Canadian populatipm. This will ensure the study population is representative and balanced. Within each stratum, subjects will be randomized using an equal allocation ratio of 1:1. Both the Intervention Group and Usual Care Group will be able to access alternative resources and additional programs and services while enrolled in the study.

Blocks of 6 will be used to randomize the participants for each strata. The block size is short enough to prevent imbalance, and long enough to prevent guessing allocation in trials.

The power analyses indicate the need to have 250 participants in total who complete the final follow-up assessment at 8 months post randomization. Based on the Investigators past intervention research as well as sleep intervention trials in the literature, 500 participants who have successfully completed eligibility will be needed using an estimated 50% drop out rate from post-eligibility to the final follow-up assessment at 8 months. More specifically, loss of participants at each stage is estimated to be the following: 22% from post eligibility to end of baseline, 15% from post-randomization to 4 month assessment, and 13% from the 4 month to 8 month assessment.

Outcome measures will be administered to all participants at Baseline and at 4 and 8 months post-randomization online through the REDCap database. Data collected at 8 months will assess the degree of maintenance of any initial treatment effects on children's sleep in each age group, as well as examine the longer-term impact of the intervention on child and parent psychosocial health. The REDCap database will automatically contact participants via email to complete assessments. There will be automated emails from REDCap followed by phone calls from the research staff to ensure that outcome data is collected.

Study participation ends for participants in both study groups after completing the 8 month follow-up assessment. Participants in the Usual Care group will gain access to the BNBD program after their study participation is complete. The BNBD program will be accessible for the Usual Care group for 3 months.

Subject Population:

A total of 500 participants will be eligible to participate in the study. Participants will be recruited from across all Canadian provinces and territories. A target of 100 English-speaking participants will be recruited from across four geographical regions of Canada (Atlantic, Central, Prairies, West Coast and Northern Territories).

Data Analysis:

The primary outcome measures that will be used to evaluate the impact of the intervention program on insomnia symptoms are sleep efficiency based on actigraphy data and sleep efficiency based on Sleep Diary data. Two primary outcome measures are included in order to capture the variables of interest using both an objective measure of sleep (i.e., actigraphy) and a parent-report/subjective measure of sleep (i.e., Sleep Diary), thus allowing for comparison with existing research in the field. Another reason for using both objective and subjective measures is that it has been found that unblinded RCTs (i.e., in which participants know their group assignment such as the current study) have been demonstrated to be biased in favour of the active treatment, and it has been suggested that an objective measure (e.g., actigraphy) should be utilized in the assessment of outcomes. Secondary outcomes will examine the longer-term impact of change in sleep as well as the impact on the child's psychosocial health (behavioural, attentional, and emotional functioning) over the duration of the 8 month trial. We will also examine the impact on parents' fatigue levels and psychosocial health.

Primary Outcome: A mixed effect General Linear Models will be fit to the data to test if the Intervention group demonstrates improved outcomes compared to the Usual Care group. The dependent variables will be the primary outcomes assessed at 4 and 8 months post-randomization (sleep efficiency on actigraphy and the Sleep Diary). Participants will be modelled as random effects group (Intervention vs. Usual Care) and baseline covariates (age and language) will be modelled as fixed effects. A significant interaction effect between time (baseline, 4 and 8 month) and group will indicate an intervention effect for treatment.

Secondary Outcome: All secondary outcomes will be separately analyzed using Hierarchical Linear Modelling and will test differences between the two groups (Intervention vs. Usual Care) in the growth curves modelling changes in the outcome variables across the four points of measurement, controlling for age, language and other covariates.

Exploratory analyses: The investigators will examine the possibility of differential response to treatment across the three age groups using growth curve modelling of the two primary outcomes (actigraphy and Sleep Diary).

Eligibility 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).

Primary outcomes:
measure: Change in Sleep Efficiency and Onset Latency from Baseline to 8 Month Follow-up with Actigraphy
timeFrame: 8 months
measure: Change in Sleep Efficiency and Onset Latency from Baseline to 8 Month Follow-up with Sleep Diary
timeFrame: 8 months
Secondary outcomes:
measure: Tayside Children's Sleep Questionnaire (TCSQ)
timeFrame: 8 months
measure: Pediatric Quality of Life (Peds-QL)
timeFrame: 8 months
measure: Child Behaviour Checklist (CBCL)
timeFrame: 8 months
measure: Teacher Report Form (TRF)
timeFrame: 8 months
measure: Single Item Fatigue Impact Scale (SIFIS)
timeFrame: 8 months
measure: Depression Anxiety Stress Scale (DASS-21)
timeFrame: 8 months
measure: Parenting Scale (PS)
timeFrame: 8 months
measure: Sleep Disturbance Scale for Children (SDSC)
timeFrame: 8 months
Other outcomes:
measure: Demographic Questionnaire (DQ)
timeFrame: 8 months
measure: Children's Physical Activity Index (PAI)
timeFrame: 8 months
measure: Body Mass Index (BMI)
timeFrame: 8 months
measure: Parenting Rating of Clinical Significant Improvement (PRCSI)
timeFrame: 8 months
measure: Treatment Utilization (TU)
timeFrame: 4 months
measure: Willingness to Pay (WP)
timeFrame: 4 months
measure: Barriers to Treatment Participation Scale (BTPS)
timeFrame: 4 months
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 4 months
measure: Readiness for Change (RC)
timeFrame: Baseline
measure: Bedtime Routines Questionnaire (BRQ
timeFrame: 4 months
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Penny V Corkum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corkum PV, Reid GJ, Hall WA, Godbout R, Stremler R, Weiss SK, Gruber R, Witmans M, Chambers CT, Begum EA, Andreou P, Rigney G. Evaluation of an Internet-Based Behavioral Intervention to Improve Psychosocial Health Outcomes in Children With Insomnia (Better Nights, Better Days): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Mar 26;7(3):e76. doi: 10.2196/resprot.8348.