BridgeMD
Tests treatment safety and results for Insomnia
Official title Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
ClinicalTrials.gov ID: NCT07091149
What this study is testing
- What it's testing
- The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12
You may be able to join if
- 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: 1) insomnia complaints for 3+ months by child report or caregiver...
You likely can't join if
- Child exclusion:
- child unable to provide informed consent or child unable to provide assent
- child unwilling to accept random assignment
- child participation in another assigned by chance 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]...
See the full eligibility criteria
- 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: 1) insomnia complaints for 3+ months by child report or caregiver observation that consist of (a) difficulties falling asleep, staying...
- ability to read and understand English at the 5th grade level
- willing to accept random assignment.
- Child exclusion:
- child unable to provide informed consent or child unable to provide assent
- child unwilling to accept random assignment
- child participation in another assigned by chance 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)
- 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 assigned by chance 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
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.