Status:
RECRUITING
Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior
Lead Sponsor:
Jeff Bridge
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Insomnia
Suicidal Ideation
Eligibility:
All Genders
11-18 years
Phase:
NA
Brief Summary
This study will test the effectiveness of a sleep-related primary suicide prevention program entitled TAILOR (Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior), which includes...
Detailed Description
This study will test the effectiveness of TAILOR, a multifaceted intervention designed to reduce sleep problems and markers of suicide risk in adolescents. The TAILOR intervention will incorporate 3 d...
Eligibility Criteria
Inclusion
- Inclusion:
- Nationwide Children's Hospital patients
- Between the ages of 11 years, 0 months, and 18 years, 11 months, inclusive at time of consent
- Endorse both recent (past 90 days) suicidal ideation and sleep problems (past 30 days)
- Resides with primary caregiver who has legal authority to consent to research participation
- Exclusion:
- Suicide attempt in the past 3 months
- Diagnosis of Bipolar Disorder or Psychosis
- Having a change to an antipsychotic and/or mood stabilizer medication regimen within the last 2 months
- Snoring at least 3 nights per week that can be heard a room or two away, even without a cold or flu or during allergy season
- Gasping for air while sleeping, diagnosis of Obstructive Sleep Apnea, or turning blue within the past year
- Body Mass Index \> 40
- Daytime symptoms of Restless Leg Syndrome
- Diagnosis of Narcolepsy
- Diagnosis of Seizures or Epilepsy, or prescribed anticonvulsant medication, within the past 4 years
- Significant substance use in the past month
- Currently receiving sleep disorder services from a sleep clinic
- Inability to speak/read English adequately to understand and complete study consent and procedures
- No access to a telephone or internet-connecting device
- Sibling already in the study
Exclusion
Key Trial Info
Start Date :
October 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05390918
Start Date
October 20 2022
End Date
July 1 2026
Last Update
March 21 2025
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205