InsomniaNCT07048340
Cognitive-behavioral Therapy for Insomnia in School-aged Children
A study testing Cognitive Behavioral Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia without SRT in people with Insomnia, run by Tel Aviv University at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia without SRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Jul 2025to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv University
Tel Aviv, Israel, 4641729
Michal Kahn, PhD, +972-544682588, michalkahn10@gmail.com
Shai Nimrodi, MA, =972-58-426-6060, shainimrodi@gmail.com
About this study
Official title: The Role of Sleep Restriction Therapy in Cognitive-behavioral Therapy for Insomnia in School-aged Children: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Cognitive Behavioral Therapy for Insomnia without SRT
- Keywords
- Insomnia, Pediatric insomnia, CBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
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 SRTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | Families will receive the complete Cognitive Behavioral Therapy for Insomnia protocol (intake session + 4 CBT-I sessions). Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Total nighttime sleep duration will be assessed using actigraphy
Measured: 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
Total nighttime sleep duration will be assessed using sleep diaries completed by parents.
Measured: 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
Number of nighttime awakenings will be assessed using actigraphy.
Measured: 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
The number of nighttime awakenings will be assessed using daily sleep diaries filled by parents.
Measured: 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
Parents will report in daily sleep diaries whether co-sleeping (sharing a room or bed with the child) occured.
Measured: Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)
Child sleep related problems
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.
Measured: Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start10 Jul 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Israel Science Foundation
- Responsible party
- Principal investigator, Michal Kahn, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048340
- Sponsor's protocol ID
- 0010319-2
- Status last verified
- Sep 2025
- First submitted
- 26 May 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified individual participant data upon reasonable request, including baseline demographic and clinical characteristics (e.g., age, gender, diagnosis, symptom severity at baseline), intervention assignment, and primary and secondary outcome measures. Data will be fully anonymized to protect participant confidentiality before sharing.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sleep Restriction Therapy in Cognitive-behavioral Therapy for Insomnia in School-aged Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07048340
- Acronym / sponsor ID
- 0010319-2
- Conditions
- Insomnia
- Keywords
- Insomnia, Pediatric insomnia, CBT-I
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Israel Science Foundation
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaFamilies will receive the complete Cognitive Behavioral Therapy for Insomnia protocol (intake session + 4 CBT-I sessions). |
| CBT-I without SRT | Active comparator | Behavioral: Cognitive Behavioral Therapy for Insomnia without SRTFamilies will receive the Cognitive Behavioral Therapy for Insomnia protocol (intake session + 4 CBT-I sessions), excluding the Sleep Restriction Therapy (SRT) components. |
| 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaCBT-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. | Behavioural | CBT-I |
| Cognitive Behavioral Therapy for Insomnia without SRTThis 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. | Behavioural | CBT-I without SRT |
Primary outcome
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.
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).
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Yes. We will share de-identified individual participant data upon reasonable request, including baseline demographic and clinical characteristics (e.g., age, gender, diagnosis, symptom severity at baseline), intervention assignment, and primary and secondary outcome measures. Data will be fully anonymized to protect participant confidentiality before sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia without SRT in people with Insomnia, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Kahn, PhD (+972544682588, michalkahn10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of child insomnia (time frame: Baseline, post-treatment (5 weeks following baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025; AzTrials last refreshed its copy on 4 Nov 2026.