Cognitive-behavioral Therapy for Insomnia in School-aged Children

ConditionInsomnia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age7-11

SponsorTel Aviv University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: CBT-IExperimental treatment 1 intervention

Group B: CBT-I without SRTActive comparator 1 intervention

Group C: Waitlist controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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).

Time frame

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

Secondary outcomes

Child sleep duration - actigraphic

Total nighttime sleep duration will be assessed using actigraphy

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

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

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

Number of nighttime awakenings will be assessed using actigraphy.

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

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

Time frame

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

Other outcomes

Child pre-sleep hyperarousal

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

Time frame

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

Parental accommodation score (FASS-PR)

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.

Time frame

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

Parental accommodation - Kalhish Questionnaire

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.

Time frame

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

Child externalizing and internalizing symptoms

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

Time frame

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

Sponsors and contacts

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Tel Aviv University

Lead sponsor

Israel Science Foundation

Collaborator

Source ClinicalTrials.gov

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