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NCT Number: NCT07048340

Cognitive-behavioral Therapy for Insomnia in School-aged Children

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv University

Tel Aviv, Israel, 4641729

Location status: Recruiting

Location contact

Michal Kahn, PhD

CONTACT

[email protected]

+972-544682588

Michal Kahn, PhD

PRINCIPAL_INVESTIGATOR

Shai Nimrodi, MA

CONTACT

[email protected]

=972-58-426-6060

About this study

Insomnia stands out as the most prevalent sleep disorder in youth, inflicting a range of adverse consequences on both the child and the family. While cognitive-behavioral therapy for insomnia (CBT-I) is considered the first-line treatment, empirical investigations into its efficacy in school-aged children have been scarce. Moreover, the unique contributions and underlying mechanisms of individual treatment components of the CBT-I 'package' remain poorly understood. Sleep Restriction Therapy (SRT) is acknowledged as a core module of CBT-I in adults, presumably driving clinical change via increases in homeostatic sleep pressure that facilitate sleep onset and maintenance. Yet, the incremental benefits of SRT within the context of CBT-I have not been systematically examined. Similarly, the role of two key mechanisms in the CBT-I 'package'-pre-sleep hyperarousal and parental over-accommodation-as mediators of treatment outcome has not been investigated. As for treatment moderators, the frequently encountered lack of motivation among children to engage in therapy poses a notable barrier to effective insomnia treatment, a barrier that SRT may potentially alleviate by offering the appeal of a later bedtime. Given the unique characteristics of insomnia in school-aged children and the prominent role played by parents in etiology and treatment, understanding these processes is pivotal. The proposed dismantling trial is designed to address these issues by rigorously testing the efficacy of CBT-I, including and excluding the SRT module, meticulously examining underlying mechanisms, and determining which variation of the intervention may be more suitable for specific children.

A total of 120 children aged 7-11 with chronic insomnia disorder will be randomized to one of 3 study arms: (1) CBT-I; (2) CBT-I without SRT; or (3) a waitlist control group. Assessments will occur at baseline, mid- treatment, post-treatment, and 3-month follow-up. Insomnia and sleep-wake patterns will be assessed objectively via actigraphy, complemented by parent and child questionnaires, sleep diaries, and a clinical diagnostic interview. Additional factors will be measured, including the child's presleep hyperarousal, separation anxiety, behavioral and emotional problems, as well as parental accommodation, distress and anxiety, and cry tolerance. Some of these factors will be tested as possible mediators (pre-sleep hyperarousal, parental accommodation, child motivation to engage in treatment, and family adherence to treatment) and moderators (parent and child levels of emotional or behavioral problems at baseline) of treatment outcome. Parents' satisfaction with treatment will also be assessed at post-treatment. Participants allocated to the waitlist control group will all receive CBT-I after the 5-week waiting period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Clinical assessment of child insomnia

    Time frame: Baseline, post-treatment (5 weeks following baseline)

    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.

  2. Child sleep efficiency

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

    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).

Secondary outcomes

  1. Child sleep duration - actigraphic

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

    Total nighttime sleep duration will be assessed using actigraphy

  2. Child sleep duration - parent reports

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

    Total nighttime sleep duration will be assessed using sleep diaries completed by parents.

  3. Child number of awakenings - actigraphic

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

    Number of nighttime awakenings will be assessed using actigraphy.

  4. Child number of awakenings - parent reports

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

    The number of nighttime awakenings will be assessed using daily sleep diaries filled by parents.

  5. Number of nights of co-sleeping

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

    Parents will report in daily sleep diaries whether co-sleeping (sharing a room or bed with the child) occured.

  6. Child sleep related problems

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

    Sleep behaviors and difficulties will be measured using the Children's Sleep Habit Questionnaire (CSHQ) - a 33-item parent-report measure of sleep behaviors and difficulties.

Other outcomes

  1. Child pre-sleep hyperarousal

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

    Presleep Hyperarousal will be assessed using The Pre-Sleep Arousal Survey for Children (PSAS-C), administered to the child by clinicians.

  2. Parental accommodation score (FASS-PR)

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

    Both parents will complete The Family Accommodation Scale for Sleep- Parent Report (FASS-PR), and a total score will be computed, with higher scores indicating greater parental accommodation.

  3. Parental accommodation - Kalhish Questionnaire

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

    Both parents will complete The Kalhish Questionnaire, measuring parental cognitions regarding child's anxiety. A total score will be computed, with higher scores indicating more parental cognitions endorsing accommodation.

  4. Child externalizing and internalizing symptoms

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

    Child behavioral problems will be assessed using the Strengths and Difficulties Questionnaire (SDQ), parent version.

  5. Parent depression, anxiety, and stress

    Time frame: Baseline and post-treatment (5 weeks following baseline)

    Parent depression, anxiety, and stress symptoms will be assessed using the DASS-21.

  6. Child separation anxiety

    Time frame: Baseline and post treatment (5 weeks following baseline)

    Separation anxiety will be measured using 8 items from the separation anxiety subscale of the Screen for Childhood Anxiety Related Disorders questionnaire (SCARED).

  7. Parental cry tolerance

    Time frame: Baseline

    Parents will undergo the Intervention Delay to Infant Crying Video (IDICV), which measures response time to a crying baby.

    The IDICV includes a presentation of a 2-min video clip of a 6-month-old baby playing on a carpet who then starts crying (after 10s), with a gradual increase in crying intensity and visual distress signs. Directions prior to the video presentation include that the parents of the baby are trying to ignore some of his crying to allow him to calm down by himself, and participants are asked to decide when they feel that it is absolutely necessary to intervene.

  8. Treatment adherence - parent reports

    Time frame: After each of the 4 therapy sessions, including session 1 (1 week after baseline), session 2 (2 weeks after basline), 3 (3 weeks after baseline), and 4 (5 weeks after baseline).

    Parents will complete a questionnaire regarding their adherence to the treatment protocol after every session. Parent ratings will be averaged to create a parental adherence score, with higher scores indicating higher adherence to treatment.

  9. Treatment adherence - therapist reports

    Time frame: After each of the 4 therapy sessions, including session 1 (1 week after baseline), session 2 (2 weeks after basline), 3 (3 weeks after baseline), and 4 (5 weeks after baseline).

    Therapists will evaluate the family's adherence to the treatment protocol after every session. Ratings will be averaged to create a family adherence score, with higher scores indicating higher adherence to treatment.

  10. Child motivation for treatment - child reports

    Time frame: After each of the 4 therapy sessions, including session 1 (1 week after baseline), session 2 (2 weeks after basline), 3 (3 weeks after baseline), and 4 (5 weeks after baseline).

    Children will answer modified questions from the Child Motivation Scale, administered by the clinician. Ratings will be averaged to create a child motivation score, with higher scores indicating higher motivation for treatment.

  11. Child motivation for treatment - therapist reports

    Time frame: After each of the 4 therapy sessions, including session 1 (1 week after baseline), session 2 (2 weeks after basline), 3 (3 weeks after baseline), and 4 (5 weeks after baseline).

    Therapists will also assess the motivation of the family (child and parents) on questionnaire items. Ratings will be averaged to create a family motivation score, with higher scores indicating higher motivation for treatment.

  12. Treatment satisfaction - parent reports

    Time frame: After each of the 4 therapy sessions, including session 1 (1 week after baseline), session 2 (2 weeks after basline), 3 (3 weeks after baseline), and 4 (5 weeks after baseline).

    Parents will answer questions regarding their satisfaction with the treatment and their relationship with the clinician. Ratings will be averaged to create a total satisfaction score, with higher scores indicating higher satisfaction from treatment.

  13. Treatment satisfaction - child reports

    Time frame: After each of the 4 therapy sessions, including session 1 (1 week after baseline), session 2 (2 weeks after basline), 3 (3 weeks after baseline), and 4 (5 weeks after baseline).

    Children will answer questions regarding their satisfaction with the treatment after each session. Their ratings will be averaged to create a total satisfaction score, with higher scores indicating higher satisfaction from treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Michal Kahn, PhD

CONTACT

[email protected]

+972544682588

Shai Nimrodi, MA

CONTACT

[email protected]

058-426-6060

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Collaborators

  • Israel Science Foundation

Registry information

Official study title

The Role of Sleep Restriction Therapy in Cognitive-behavioral Therapy for Insomnia in School-aged Children: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 2, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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