Actively Recruiting

Phase Not Applicable
Age: 7Years - 11Years
All Genders
NCT07048340

Cognitive-behavioral Therapy for Insomnia in School-aged Children

Led by Tel Aviv University · Updated on 2025-09-18

120

Participants Needed

1

Research Sites

229 weeks

Total Duration

On this page

Sponsors

T

Tel Aviv University

Lead Sponsor

I

Israel Science Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cognitive-behavioral Therapy for Insomnia in School-aged Children

Who Can Participate

Age: 7Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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).
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Tel Aviv University

Tel Aviv, Israel, Israel, 4641729

Actively Recruiting

Loading map...

Research Team

M

Michal Kahn, PhD

CONTACT

S

Shai Nimrodi, MA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here