NCT05390918 Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior
| NCT ID | NCT05390918 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jeff Bridge |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 235 participants |
| Start Date | 2022-10-20 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 235 participants in total. It began in 2022-10-20 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 specific behavior-change strategies for adolescents at risk of suicidal behavior who suffer from difficulties falling asleep, staying asleep, and/or insufficient sleep.
Eligibility Criteria
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
Contact & Investigator
Jeff Bridge, Ph.D.
PRINCIPAL INVESTIGATOR
Nationwide Children's Hospital
Frequently Asked Questions
Who can join the NCT05390918 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 18 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05390918 currently recruiting?
Yes, NCT05390918 is actively recruiting participants. Contact the research team at elizabeth.cannon@nationwidechildrens.org for enrollment information.
Where is the NCT05390918 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT05390918 clinical trial?
NCT05390918 is sponsored by Jeff Bridge. The principal investigator is Jeff Bridge, Ph.D. at Nationwide Children's Hospital. The trial plans to enroll 235 participants.
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