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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2-months & 4-months

Awards & highlights

TAILOR Trial 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.Check my eligibility

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.See study design

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.

TAILOR Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

TAILOR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

TAILOR 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jeff BridgeLead Sponsor

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,477,212 Total Patients Enrolled

Jeff Bridge, Ph.D.Principal InvestigatorNationwide Children's Hospital

Media Library

TAILOR Clinical Trial Eligibility Overview. Trial Name: NCT05390918 — N/A

Insomnia Research Study Groups: TAILOR, Enhanced Usual Care (EUC)

Insomnia Clinical Trial 2023: TAILOR Highlights & Side Effects. Trial Name: NCT05390918 — N/A

TAILOR 2023 Treatment Timeline for Medical Study. Trial Name: NCT05390918 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available for participants in this medical trial?

"According to the clinical trials website, this medical trial began enrolling participants on October 20th 2020 and is still actively recruiting. The details were last updated on October 25th 2022."

Answered by AI

Do I meet the criteria to participate in this research study?

"This research trial is seeking to enrol 190 minors between 12 and 17 years of age who are experiencing suicidal ideations. Furthermore, they must meet the following criteria: be a current patient at Nationwide Children's Hospital; have a legal guardian able to give consent for the study participation; report recent (90 days) suicide attempts or sleep problems (30 days); possess either Bipolar disorder or Psychosis diagnosis; experience alteration in antipsychotic/mood stabilizer medication within 2 months prior to entry; snore noisily 3 nights per week even if not affected by illness, allergy season etc.; and present with Body Mass Index higher than 40"

Answered by AI

Is the upper age limit for this experimentation open-ended?

"This trial is enrolling participants aged 12 to 17."

Answered by AI

What is the current participant count for this research endeavor?

"Affirmative. According to the data available on clinicaltrials.gov, this research project is actively seeking patients and was first posted on October 20th 2022. As of today's date, it has been edited most recently on October 25th 2022 and 190 participants are needed at a single medical centre."

Answered by AI

What are the main aims of this clinical investigation?

"The principal outcome of this clinical trial, which will be evaluated through a baseline, two-month and four-month time frame is to measure changes in insomnia levels expressed on the Adolescent Sleep Wake Scale (ASWS) after two months and again after four. Other secondary objectives involve assessing substance use via Drug Use Screening Inventory (DUSI), socio-economic information using the General Information Sheet (GIS) as well as parent/child conflict with Conflict Behavior Questionnaire (CBQ)."

Answered by AI

Recent research and studies

The Journal of Clinical PsychiatryJournal

Meta-analysis of Sleep Disturbance and Suicidal Thoughts and Behaviors

Pigeon, Wilfred R., Martin Pinquart, and Kenneth Conner. 2012. “Meta-analysis of Sleep Disturbance and Suicidal Thoughts and Behaviors”. The Journal of Clinical Psychiatry. Physicians Postgraduate Press, Inc. doi:10.4088/jcp.11r07586.

Sleep Medicine ReviewsJournal

Functional Consequences of Inadequate Sleep in Adolescents: A Systematic Review

Shochat, Tamar, Mairav Cohen-Zion, and Orna Tzischinsky. 2014. “Functional Consequences of Inadequate Sleep in Adolescents: A Systematic Review”. Sleep Medicine Reviews. Elsevier BV. doi:10.1016/j.smrv.2013.03.005.

SleepJournal

Resilience and Readiness Through Restorative Sleep

Germain, Anne. 2015. “Resilience and Readiness Through Restorative Sleep”. Sleep. Oxford University Press (OUP). doi:10.5665/sleep.4388.

Journal of Clinical PsychologyJournal