Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr

University of South Florida40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Insomnia

Interventions

CBT-IBEHAVIORAL

Cognitive behavioral therapy for insomnia

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: Child inclusion: 1. 6-12 yrs 2. Verbal IQ \> 70 (to ensure verbal skills are sufficient to participate in treatment) 3. participation of child's parent or legal guardian living in the same home 4. child diagnosed with insomnia, 5) willing to accept random assignment. 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: 1. ability to read and understand English at the 5th grade level 2. willing to accept random assignment. Exclusion Criteria: Child exclusion: 1. child unable to provide informed consent or child unable to provide assent 2. child unwilling to accept random assignment 3. child participation in another randomized research project 4. child unable to complete forms or implement treatment procedures due to cognitive impairment 5. child untreated medical comorbidity including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias) 6. child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin as described in #7 (see Notes below for details) 7. child stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months) 8. child participation in non-pharmacological treatment (including CBT) for sleep outside current trial 9. child other conditions adversely affecting trial participation. Caregiver exclusion criteria: 1. unable to provide informed consent 2. unwilling to accept random assignment 3. caregiver participation in another randomized research project 4. unable to complete forms or implement treatment procedures due to cognitive impairment 5. caregiver participation in non-pharmacological treatment (including CBT) for sleep outside current trial

Locations (1)

University of South Florida

Tampa, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up

Session Completion

Percentage of treatment sessions completed

Time frame: within 1 week post-treatment

Treatment Adherence

Percentage of instructions followed as indicated on treatment adherence logs

Time frame: 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.

Time frame: within 1 week post-treatment

Treatment Satisfaction Survey

Central Contacts

Christina S McCrae, PhD

CONTACT

813-974-1804 christinamccrae@usf.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up

Heart rate variability - Caregiver

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 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

Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up