Cognitive-behavioral Therapy for Insomnia in School-aged Children

NCT07048340 | Recruiting

• 1 other identifier: 0010319-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Insomnia

Keywords

Insomnia; Pediatric insomnia; CBT-I

Outcome Measures

Primary Outcomes (2)

• Clinical assessment of child insomnia

  A structured interview with the child and parents will be conducted at both baseline and post-treatment by a blind clinical assessor. Based on ICSD-3 criteria, children will be diagnosed with chronic insomnia disorder if their sleep difficulties are evident on ≥3 nights per week, persisting for ≥3 months. The interview will additionally address sleep-related behaviors (e.g., reliance on parents for sleep onset), daytime consequences, and differential diagnosis. The clinical diagnosis of insomnia at baseline will serve to confirm that the child qualifies for inclusion in the trial. At post-treatment, the percentage of children no longer meeting the criteria for the disorder will be considered a primary outcome measure.

  Baseline, post-treatment (5 weeks following baseline)

• Child sleep efficiency

  Sleep efficiency will be measured using actigraphy and sleep diaries completed by parents. Sleep efficiency is computed as the percent of total sleep duration out of time in bed (including sleep onset latency and any wakefulness after sleep onset).

  Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)

Secondary Outcomes (6)

• Child sleep duration - actigraphic

  Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)

• Child sleep duration - parent reports

  Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)

• Child number of awakenings - actigraphic

  Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)

• Child number of awakenings - parent reports

  Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)

• Number of nights of co-sleeping

  Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)

Other Outcomes (13)

• Child pre-sleep hyperarousal

  Baseline, mid-treatment (3 weeks following baseline), and post-treatment (5 weeks following baseline).

• Parental accommodation score (FASS-PR)

  Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)

• Parental accommodation - Kalhish Questionnaire

  Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)

Study Arms (3)

CBT-I

EXPERIMENTAL

Families will receive the complete Cognitive Behavioral Therapy for Insomnia protocol (intake session + 4 CBT-I sessions).

Behavioral: Cognitive Behavioral Therapy for Insomnia

CBT-I without SRT

ACTIVE COMPARATOR

Families will receive the Cognitive Behavioral Therapy for Insomnia protocol (intake session + 4 CBT-I sessions), excluding the Sleep Restriction Therapy (SRT) components.

Behavioral: Cognitive Behavioral Therapy for Insomnia without SRT

Waitlist control

NO INTERVENTION

Families will complete the intake session and then be placed on a waitlist and receive CBT-I 5 weeks after baseline.

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

CBT-I intervention will include four 45-60 minute sessions with a clinician. The sessions will include CBT-I components such as sleep psychoeducation, bedtime routines and sleep hygiene, graduated exposure, cognitive restructuring, and SRT in one of the intervention groups. The protocol is based on previous studies of CBT-I for school-aged children.

CBT-I

Cognitive Behavioral Therapy for Insomnia without SRT BEHAVIORAL

This intervention will include four 45-60 minute sessions with a clinician. The sessions will include CBT-I components such as sleep psychoeducation, bedtime routines and sleep hygiene, graduated exposure, and cognitive restructuring. Sleep Restriction Therapy will not be included in the intervention. The protocol is based on previous studies that delivered CBT-I to school-aged children.

CBT-I without SRT

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Tel Aviv University: lead
• Israel Science Foundation: collaborator

Study Sites (1)

Tel Aviv University

Tel Aviv, Israel, 4641729, Israel

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Michal Kahn, PhD

CONTACT

+972544682588; michalkahn10@gmail.com

Shai Nimrodi, MA

CONTACT

058-426-6060; shainimrodi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: July 2, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From June 2025 Until 7 years after study completion (anticipated December 2029)
• Access Criteria: Qualified researchers affiliated with academic or clinical institutions will be able to request access to the de-identified individual participant data (IPD) and supporting documentation. Requests for access will be reviewed on a case-by-case basis to ensure appropriate use and compliance with ethical and legal standards. Interested researchers can submit a data request to the corresponding author via email, including a brief proposal outlining the intended use and planned analyses. A data sharing agreement will be required prior to access. Data will be shared electronically via secure institutional file transfer systems.

Locations

IL (1)