Primary Insomnia Clinical Trial
Official title:
Better Nights, Better Days: Improving Psychosocial Health Outcomes in Children With Behavioural Insomnia
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.
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).
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