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The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.
This is a pilot study to examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children aged 6-12 with insomnia and their caregiver(s) compared to a waitlist control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I | Experimental | Immediate CBT-I for typically developing children using a 4-session digital intervention. |
|
| Waitlist Control | Other | Participants in the waitlist control will have delayed treatment (4 weeks later). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-I | Behavioral | Cognitive behavioral therapy for insomnia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Electronic Sleep Diaries - Child | Primary: child sleep onset latency (lights-out until sleep onset) and total sleep time. All other sleep diary variables are secondary (e.g., sleep efficiency (total sleep time/time in bed x 100%). Child (with caregiver assistance) and caregiver complete electronic diaries each morning (~5 mins) during each 1-week assessment and throughout treatment. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Actigraphy - Child | Primary variables: child sleep onset latency and total sleep time. All other actigraphy variables are secondary. Children wear actigraphs (Fitbit Inspire 3, Google), watch-like device, that monitors light and gross motor activity. Data analyzed using 30s epochs. Validated algorithm estimates SOL, TST, WASO, sleep efficiency and other variables provided by diaries. A combination of diary and actigraphy data estimates bed/waketime variability. Children wear devices 24/7 during each 1-week assessment. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Session Completion | Percentage of treatment sessions completed | within 1 week post-treatment |
| Treatment Adherence | Percentage of instructions followed as indicated on treatment adherence logs | within 1 week post-treatment |
| Internet Intervention Utility Questionnaire (IIUQ) | 16-item measure designed to assess usability, likeability, usefulness, understandability, and convenience of an Internet intervention using a 5-point Likert scale, ranging from 0 (not at all) to 4 (very). Two additional open-ended questions ask about the most and least helpful aspects of the program. Scoring range is 0-64. | within 1 week post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Child Sleep Habits Questionnaire-Abbreviated | The Child Sleep Habits Questionnaire - Abbreviated consists of 22 questions regarding child sleep behaviors on a 1 point scale (0 = never, 7 = always). Higher scores indicating issues with sleep habits. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Pubertal Development Scale (PDS) | Self-report questionnaire used to assess pubertal status | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
Inclusion Criteria:
Child inclusion:
Insomnia:
1) insomnia complaints for 3+ months by child report or caregiver observation that consist of (a) difficulties falling asleep, staying asleep, and/or waking up too early, (b) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, and (c) Pediatric Insomnia Severity Index score >8
Caregiver inclusion:
Exclusion Criteria:
Child exclusion:
Caregiver exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina S McCrae, PhD | Contact | 813-974-1804 | christinamccrae@usf.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42210669 | Derived | McCrae CS, Stearns MA, Mazurek MO, Page J, Holland B, Takagishi J, Emmanual P, Zhang X, Kapolka M, Craggs C, Gonzalez D, Owens J. Digital Cognitive Behavioral Treatment of Insomnia in Youth: Protocol for an RCT Examining Feasibility, Acceptability, and Efficacy of LAMBI. Behav Sleep Med. 2026 May 28:1-15. doi: 10.1080/15402002.2026.2667840. Online ahead of print. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Participants will be randomized to either CBT-I or a waitlist control
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| Treatment Satisfaction Survey | 9-item measure designed to provide feedback on the study, including its structure, assessments, scheduling, working with study staff, and the usability of the intervention platforms using a 10-point Likert scale, ranging from 1 (strongly disagree) to 10 (strongly agree) and open-ended questions | within 1 week post-treatment |
| Pediatric Insomnia Severity Index | The Pediatric Insomnia Severity Index is a six-item questionnaire that assesses insomnia symptom severity in children 4-10 years old. Items are rated on a 0-6 point scale based on the child's sleep over the past week. Scoring range is 0-30 with with higher scores indicating greater insomnia severity. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Pediatric Symptom Checklist-17 |
The Pediatric Symptom Checklist-17 is a 17-item questionnaire that measures attention, internalizing, and externalizing problems on a 0-2 scale. Scores range from 0-34 with higher score indicates a greater level of psychosocial impairment. |
| baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Behavior Rating Inventory of Executive Function -2nd Edition (BRIEF-2) | The Behavior Rating Inventory of Executive Function -2nd Edition (BRIEF-2) is an 86-item caregiver-report measure of day-to-day executive functioning and impairment. T-scores ranging from 30-90 with higher scores indicating greater executive functioning difficulties | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Pediatric Daytime Sleepiness Scale | The Pediatric Daytime Sleepiness Scale is an 8-item questionnaire that measures daytime sleepiness and school-related outcomes on a 5-point scale. Scores range from 0-32 with higher scores indicating greater daytime sleepiness. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Revised Children's Anxiety and Depression Scale-25 | The Revised Children's Anxiety and Depression Scale-25 (caregiver report) is a 25-item scale that measures levels of anxiety and depression on a 4-point scale. Scores range from 0-75 with higher scores indicating more severity in symptoms. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Strengths and Difficulties Questionnaire | The Strengths and Difficulties Questionnaire is a 25-item questionnaire that measures five scales (emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior) on a 4-point scale. Scores range from 0-40 with higher scores indicating greater difficulties across emotional, behavioral, and peer domains. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Heart rate variability - Child | HRV will be assessed using Holter Monitoring during an established stress reactivity protocol. Participants will be seated at rest and undergo Holter Monitoring procedures: 1) 5 min baseline, 2) 30 secs vibrotactile stimuli (Conair WM200X, Stamford, CT) at 80 Hz oscillations applied to left hand, 3) 3 min recovery, 4) 30 secs vibrotactile stimuli applied to right hand, 5) 3 min recovery, 6) cold pressor stimulation to right hand (place hand to bottom of bowl of ice water calibrated to 4° C), 7) 3 min recovery, 8) cold pressor stimulation to left hand. Time and spectral analysis of short-term HRV during baseline, vibration and cold pressor stimuli will be conducted in BioPAC software. Time (reflects beat-to-beat variability-RMSDNN, pNN50) and frequency [reflects underlying HR rhythms-High (0.15-0.4 Hz), low (0.04-0.15 Hz), very low (below 0.04 Hz), LF/HF ratio] domains will be examined. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Peds Quality of Life | PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. Caregiver forms will be completed. Scores ranges from 0-100 with higher scores indicating better quality of life. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Heart rate variability - Caregiver | HRV will be assessed using Holter Monitoring during an established stress reactivity protocol. Participants will be seated at rest and undergo Holter Monitoring procedures: 1) 5 min baseline, 2) 30 secs vibrotactile stimuli (Conair WM200X, Stamford, CT) at 80 Hz oscillations applied to left hand, 3) 3 min recovery, 4) 30 secs vibrotactile stimuli applied to right hand, 5) 3 min recovery, 6) cold pressor stimulation to right hand (place hand to bottom of bowl of ice water calibrated to 4° C), 7) 3 min recovery, 8) cold pressor stimulation to left hand. Time and spectral analysis of short-term HRV during baseline, vibration and cold pressor stimuli will be conducted in BioPAC software. Time (reflects beat-to-beat variability-RMSDNN, pNN50) and frequency [reflects underlying HR rhythms-High (0.15-0.4 Hz), low (0.04-0.15 Hz), very low (below 0.04 Hz), LF/HF ratio] domains will be examined. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Actigraphy - Caregiver | Caregiver sleep diary variables include sleep onset latency (lights-out until sleep onset), wake after sleep onset, total sleep time, and sleep efficiency (total sleep time/time in bed x 100%). Caregivers wear actigraphs (Fitbit Inspire 3, Google), a watch-like device that monitors light and gross motor activity. Data analyzed using 30s epochs. Validated algorithm estimates SOL, TST, WASO, sleep efficiency and other variables provided by diaries. A combination of diary and actigraphy data estimates bed/waketime variability. Caregivers wear devices 24/7 during each 1-week assessment. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Electronic Sleep Diaries - Caregiver | Caregiver sleep diary variables include sleep onset latency (lights-out until sleep onset), wake after sleep onset, total sleep time, and sleep efficiency (total sleep time/time in bed x 100%). Caregiver will complete electronic diaries each morning (~5 mins) during each 1-week assessment and throughout treatment. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| State-Trait Anxiety Inventory (STAI-Y1) - Caregiver | State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the caregiver generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. Scores range from 20-80 with higher scores indicate greater levels of anxiety. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Beck Depression Inventory -II - Caregiver | Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). Scores range from 0-63 with higher scores indicating higher severity of depressive symptoms. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Fatigue Severity Scale - Caregiver | Fatigue Severity Scale includes 9 items on severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). Scores range from 9-63 with higher scores indicating severe fatigue symptoms. | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Daily Fatigue - Caregiver | Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable) | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| Caregiver Strain Index - Caregiver | Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. Scoring range 0-26 with higher scores indicate greater caregiver strain | baseline, within 1 week post treatment, 1 month follow up, 3 month follow up |
| D001523 |
| Mental Disorders |