Recruiting

Digital CBT-I

Sponsor:

University of South Florida

Code:

NCT07091149

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Interventions

CBT-I

Study Details

Brief summary:

The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.

Conditions

Insomnia

Study ID

NCT07091149

Start date

Apr 10, 2025

Status verified date

Jun, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBT-I

Immediate CBT-I for typically developing children using a 4-session digital intervention.

other: Waitlist Control

Participants in the waitlist control will have delayed treatment (4 weeks later).

Interventions

CBT-I

Cognitive behavioral therapy for insomnia

Primary outcome measure

  • Electronic Sleep Diaries - Child [ Time Frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up ]
  • Actigraphy - Child [ Time Frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up ]
  • Session Completion [ Time Frame: within 1 week post-treatment ]
  • Treatment Adherence [ Time Frame: within 1 week post-treatment ]
  • Internet Intervention Utility Questionnaire (IIUQ) [ Time Frame: within 1 week post-treatment ]
  • Treatment Satisfaction Survey [ Time Frame: within 1 week post-treatment ]
  • Pediatric Insomnia Severity Index [ Time Frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up ]

Central Contacts and Locations

Central contacts

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

More Information

Sponsor

University of South Florida

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • dCBTi
  • digital intervention
  • insomnia
  • children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-06-15.