InsomniaNiteCAPP JRNCT07091149
Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
A study testing CBT-I in people with Insomnia, run by University of South Florida at 1 site in United States.
Trial summary
The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Insomnia
- What is being tested?
- CBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2025to 1 May 2027
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child inclusion:
- 6-12 yrs
- Verbal IQ > 70 (to ensure verbal skills are sufficient to participate in treatment)
- participation of child's parent or legal guardian living in the same home
- child diagnosed with insomnia, 5) willing to accept random assignment.
- Insomnia:
Show all 10Show fewer
- 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:
- ability to read and understand English at the 5th grade level
- willing to accept random assignment.
Who cannot join
- Child exclusion:
- child unable to provide informed consent or child unable to provide assent
- child unwilling to accept random assignment
- child participation in another randomized research project
- child unable to complete forms or implement treatment procedures due to cognitive impairment
- child untreated medical comorbidity including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, [frequent] parasomnias)
Show all 16Show fewer
- 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)
- child stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)
- child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
- child other conditions adversely affecting trial participation.
- Caregiver exclusion criteria:
- unable to provide informed consent
- unwilling to accept random assignment
- caregiver participation in another randomized research project
- unable to complete forms or implement treatment procedures due to cognitive impairment
- caregiver participation in non-pharmacological treatment (including CBT) for sleep outside current trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jhanavi Sabharwal contact
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33612
Christina S McCrae, PhD
About this study
The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.
Read the detailed description
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.
- Conditions
- Insomnia
- Being tested
- CBT-I
- Keywords
- dCBTi, digital intervention, insomnia, children
- 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.
CBT-IBehavioural
Cognitive behavioral therapy for insomnia
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | Immediate CBT-I for typically developing children using a 4-session digital intervention. Receives: Behavioral: CBT-I |
| Waitlist Control | Other | Participants in the waitlist control will have delayed treatment (4 weeks later). Receives: Behavioral: CBT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Session Completion
Percentage of treatment sessions completed
Measured: within 1 week post-treatment
Treatment Adherence
Percentage of instructions followed as indicated on treatment adherence logs
Measured: 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.
Measured: within 1 week post-treatment
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
Measured: 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.
Measured: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start10 Apr 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Participants will be randomized to either CBT-I or a waitlist control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina McCrae, University of South Florida
- Investigators
- Christina McCrae, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091149
- Sponsor's protocol ID
- STUDY006258
- Acronym
- NiteCAPP JR
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 42210669
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
- ClinicalTrials.gov ID
- NCT07091149
- Acronym / sponsor ID
- NiteCAPP JR / STUDY006258
- Conditions
- Insomnia
- Keywords
- dCBTi, digital intervention, insomnia, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 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.
The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either CBT-I or a waitlist control
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: CBT-IImmediate CBT-I for typically developing children using a 4-session digital intervention. |
| Waitlist Control | Other | Behavioral: CBT-IParticipants in the waitlist control will have delayed treatment (4 weeks later). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 6-12 yrs
- Verbal IQ > 70 (to ensure verbal skills are sufficient to participate in treatment)
- participation of child's parent or legal guardian living in the same home
- child diagnosed with insomnia, 5) willing to accept random assignment.
- 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
Key exclusion criteria (16 listed)
- child unable to provide informed consent or child unable to provide assent
- child unwilling to accept random assignment
- child participation in another randomized research project
- child unable to complete forms or implement treatment procedures due to cognitive impairment
- child untreated medical comorbidity including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, [frequent] parasomnias)
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 |
|---|---|---|
| CBT-ICognitive behavioral therapy for insomnia | Behavioural | CBT-I, Waitlist Control |
Primary outcome
Electronic Sleep Diaries - Child
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
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.
Actigraphy - Child
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
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.
Session Completion
Time frame: within 1 week post-treatment
Percentage of treatment sessions completed
Treatment Adherence
Time frame: within 1 week post-treatment
Percentage of instructions followed as indicated on treatment adherence logs
Internet Intervention Utility Questionnaire (IIUQ)
Time frame: within 1 week post-treatment
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.
Treatment Satisfaction Survey
Time frame: within 1 week post-treatment
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
Pediatric Insomnia Severity Index
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
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.
16 secondary outcomes
Child Sleep Habits Questionnaire-Abbreviated
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Pediatric Symptom Checklist-17
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)
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Pediatric Daytime Sleepiness Scale
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Revised Children's Anxiety and Depression Scale-25
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Strengths and Difficulties Questionnaire
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Heart rate variability - Child
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Peds 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
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Electronic Sleep Diaries - Caregiver
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
State-Trait Anxiety Inventory (STAI-Y1) - Caregiver
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Beck Depression Inventory -II - Caregiver
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Fatigue Severity Scale - Caregiver
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Daily Fatigue - Caregiver
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Caregiver Strain Index - Caregiver
Time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
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 11 Sep 2026.
- Derived from this study: PubMed 42210669McCrae 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.
- Individual participant dataSharing planned: Undecided
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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.
Jhanavi Sabharwal contact
Christina McCrae principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I in people with Insomnia, run by University of South Florida at 1 site in United States.
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 10 inclusion and 16 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 11 Sep 2026. 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 United States. 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 Britani Holland, PhD (813-974-1804, blalone@usf.eduJ), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electronic Sleep Diaries - Child (time frame: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07091149, which also lists 1 linked publication.
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 11 Sep 2026.