Program to improve sleep and reduce suicidal behavior in adolescents
Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior
This study is testing a new program to help teenagers who have trouble sleeping and are feeling suicidal, to see if it can improve their sleep and reduce their suicidal thoughts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 235 (estimated) |
| Ages | 11 Years to 18 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05390918 on ClinicalTrials.gov |
What this trial studies
This study tests the TAILOR program, which aims to improve sleep and reduce suicidal ideation in adolescents facing sleep difficulties and recent suicidal thoughts. The intervention combines Cognitive Behavioral Therapy, Motivational Interviewing, and remote support to address both sleep issues and suicidal risk. Participants will be compared to a control group receiving Enhanced Usual Care to evaluate the effectiveness of TAILOR over a period of four months.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11 to 18 who have experienced recent suicidal ideation and sleep problems.
Not a fit: Patients who have attempted suicide in the past three months or have certain psychiatric diagnoses will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce sleep problems and suicidal thoughts in adolescents, improving their overall mental health.
How similar studies have performed: Other studies have shown promise in using behavioral interventions for sleep and suicide prevention, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jeff Bridge, Ph.D. — Nationwide Children's Hospital
- Study coordinator: Elizabeth Cannon, MA, MS
- Email: elizabeth.cannon@nationwidechildrens.org
- Phone: 614-355-0578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.