Cognitive-behavioral Therapy for Insomnia in School-aged Children
Key facts
- Who runs it
- Tel Aviv University
- Where
- Tel Aviv, IsraelSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 10 Jul 2025
- Expected to end
- 1 Dec 2029
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Cognitive Behavioral Therapy for Insomnia
- Cognitive Behavioral Therapy for Insomnia without SRT
- Record updated
- 18 September 2025
Who can take part
- Age
- 7 years to 11 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Child aged 7-11 years
- Parents aged over 18 years
- Child meets the International Classification of Sleep Disorders - Third Edition (ICSD-3) criteria for chronic insomnia disorder with sleep difficulties occurring at least 3 times a week and lasting at least 3 months (Insomnia diagnosis will be determined during a clinical interview)
Who cannot take part
- Child receiving concurrent CBT treatment for sleep or anxiety disorders
- Current psychotropic medications, or sleep aid medications
- Child diagnosed with a medical sleep problem (e.g., OSA, RLS)
- Significant health or neurodevelopmental problems (e.g., intellectual disability)
- Lack of Hebrew reading and writing
- Total sleep time that is shorter than 6 hours on average per night at baseline
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 7 and 11 years old?
Where in Israel
- Tel Aviv UniversityTel Aviv, IsraelContact: Michal Kahn, PhDTaking people
About the trial
What the trial wants to find out
This randomized controlled trial will test the efficacy of CBT-I intervention for school-aged children (7-11 years old) with insomnia. The trial will focus on the role of sleep restriction therapy in treatment. Children will be randomized to one of three groups: (1) CBT-I; (2) CBT-I without SRT; or (3) a waitlist control group. Assessments will occur at baseline, mid-treatment, post-treatment, and a 3-month follow up. Some measures (e.g., child motivation) will also be assessed after each therapy session. Insomnia and sleep-wake patterns will be assessed objectively using actigraphy, and subjectively using sleep diaries, a clinical diagnostic interview, and questionnaires. Parent and child questionnaires will be administered to assess moderators and mediators of treatment outcomes.
The 3 groups in the trial
- CBT-ITreatment being tested
Families will receive the complete Cognitive Behavioral Therapy for Insomnia protocol (intake session + 4 CBT-I sessions).
Treatment: Cognitive Behavioral Therapy for Insomnia
- CBT-I without SRTExisting treatment, for comparison
Families will receive the Cognitive Behavioral Therapy for Insomnia protocol (intake session + 4 CBT-I sessions), excluding the Sleep Restriction Therapy (SRT) components.
Treatment: Cognitive Behavioral Therapy for Insomnia without SRT
- Waitlist controlNo study treatment, for comparison
Families will complete the intake session and then be placed on a waitlist and receive CBT-I 5 weeks after baseline.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Role of Sleep Restriction Therapy in Cognitive-behavioral Therapy for Insomnia in School-aged Children: A Randomized Controlled Trial
- Fit questions
- Built from NCT07048340, who can take part
- Record updated
- 18 September 2025