Digital CBT-I for Insomnia in Children Aged 6-12
This study is testing a digital program called NiteCAPP Jr, which uses Cognitive Behavioral Therapy for Insomnia (CBT-I) to help children aged 6 to 12 with insomnia. The goal is to see if NiteCAPP Jr is practical to use, if families like it, and if it helps children sleep better. Researchers will compare children using NiteCAPP Jr to a group that waits to receive the treatment. Success will be measured by changes in sleep patterns, recorded through electronic sleep diaries and a device called an actigraph (worn on the wrist to track movement and sleep), and how many sessions participants complete. This study is currently unclear on its recruitment status and plans to enroll 40 children.
- Study design
- This is a pilot study that will randomly assign 40 participants to either receive the NiteCAPP Jr program or be in a waitlist control group.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for sleep changes at baseline, within one week after treatment, and then at 1-month and 3-month follow-up appointments.
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Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Electronic Sleep Diaries - Childbaseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Primary: child sleep onset latency (lights-out until sleep onset) and total sleep time. All other sleep diary variables are secondary (e.g., sleep efficiency (total sleep time/time in bed x 100%). Child (with caregiver assistance) and caregiver complete electronic diaries each morning (\~5 mins) during each 1-week assessment and throughout treatment.
- Actigraphy - Childbaseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Primary variables: child sleep onset latency and total sleep time. All other actigraphy variables are secondary. Children wear actigraphs (Fitbit Inspire 3, Google), watch-like device, that monitors light and gross motor activity. Data analyzed using 30s epochs. Validated algorithm estimates SOL, TST, WASO, sleep efficiency and other variables provided by diaries. A combination of diary and actigraphy data estimates bed/waketime variability. Children wear devices 24/7 during each 1-week assessment.
- Session Completionwithin 1 week post-treatment
Percentage of treatment sessions completed
- Treatment Adherencewithin 1 week post-treatment
Percentage of instructions followed as indicated on treatment adherence logs
- Internet Intervention Utility Questionnaire (IIUQ)within 1 week post-treatment
16-item measure designed to assess usability, likeability, usefulness, understandability, and convenience of an Internet intervention using a 5-point Likert scale, ranging from 0 (not at all) to 4 (very). Two additional open-ended questions ask about the most and least helpful aspects of the program. Scoring range is 0-64.
- Treatment Satisfaction Surveywithin 1 week post-treatment
9-item measure designed to provide feedback on the study, including its structure, assessments, scheduling, working with study staff, and the usability of the intervention platforms using a 10-point Likert scale, ranging from 1 (strongly disagree) to 10 (strongly agree) and open-ended questions
- Pediatric Insomnia Severity Indexbaseline, within 1 week post treatment, 1 month follow up, 3 month follow up
The Pediatric Insomnia Severity Index is a six-item questionnaire that assesses insomnia symptom severity in children 4-10 years old. Items are rated on a 0-6 point scale based on the child's sleep over the past week. Scoring range is 0-30 with with higher scores indicating greater insomnia severity.