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Sleep Intervention for Suicidal Behavior (TAILOR Trial)

N/A

Recruiting

Led By Jeff Bridge, Ph.D.

Research Sponsored by Jeff Bridge

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Nationwide Children's Hospital patients between the ages of 11 years, 0 months, and 18 years, 11 months, inclusive at time of consent

Be younger than 65 years old

Must not have

Diagnosis of Narcolepsy

Currently receiving sleep disorder services from a sleep clinic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2-months & 4-months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a sleep-related suicide prevention program for adolescents at risk for suicidal behavior. The program includes behavior-change strategies for those who have difficulty sleeping.

Who is the study for?

This trial is for adolescents aged 11-18 who are patients at Nationwide Children's Hospital, have had suicidal thoughts and sleep problems recently, and live with a caregiver who can consent to research. It excludes those with certain sleep disorders, recent substance use, inadequate English skills, no phone or internet access, recent suicide attempt or medication changes.

What is being tested?

TAILOR (Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior) is being tested against Enhanced Usual Care. TAILOR includes behavior strategies for teens at risk of suicide with insomnia issues. The study aims to see if improving sleep reduces suicidal behaviors.

What are the potential side effects?

Since TAILOR involves behavioral strategies rather than medications, side effects may be minimal but could include increased anxiety or stress due to changes in routine or frustration if techniques initially do not work as expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 11 and 18 years old and a patient at Nationwide Children's Hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with narcolepsy.

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I am currently getting help for a sleep disorder from a clinic.

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I experience daytime symptoms of Restless Leg Syndrome.

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I have been diagnosed with Bipolar Disorder or Psychosis.

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I have had issues with breathing or turned blue while sleeping in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2-months & 4-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2-months & 4-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2-months & 4-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sleep Disorders

Sleeplessness

Change from baseline in aspects of suicide intent on the Suicide Intent Scale (SIS) at 2 months and 4 months

+6 more

Secondary study objectives

Biological family history of suicidal behavior on the Family History Screen (FHS)

Change from baseline in health risk behaviors on the 2017 National Youth Risk Behavior Survey at 2 months and 4 months

Change from baseline in parent-child conflict on the Conflict Behavior Questionnaire (CBQ) at 2 months and 4 months

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: TAILORExperimental Treatment1 Intervention

Half of the participants will be randomized into the experimental arm of this study. A study clinician will call each family approximately 4 times over 2 months. The study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary. The TAILOR intervention will then be administered. TAILOR includes the assessment of existing sleep problems and sleep practices and education on Cognitive Behavioral Therapy (CBT) strategies for insomnia, with Motivational Interviewing (MI) as the communication style.

Group II: Enhanced Usual Care (EUC)Experimental Treatment1 Intervention

Half of the participants will be randomized into Enhanced Usual Care (EUC). A study clinician will call each family approximately 4 times over 2 months. The study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary.

0 / 6Eligibility criteria met