Cognitive-behavioral Therapy for Insomnia in School-aged Children

Recruiting now · Not applicable

Conditions studied: Insomnia

In brief

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.

Key facts

Study ID

NCT07048340

Run by

Tel Aviv University

People needed

120

Starts

2025-07-10

Expected to finish

2029-12-01

Last updated by the study team

2025-09-18

Who can join

Age: 7 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Child receiving concurrent CBT treatment for sleep or anxiety disorders.
• Child diagnosed with a medical sleep problem (e.g., OSA, RLS)
• Significant health or neurodevelopmental problems (e.g., intellectual disability)
• Current psychotropic medications, or sleep aid medications
• Lack of Hebrew reading and writing
• Total sleep time that is shorter than 6 hours on average per night at baseline

Where it is running

• Tel Aviv University — Tel Aviv, Israel, Israel (enrolling)

Full record on ClinicalTrials.gov

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