NCT05390918

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Oct 2022Feb 2027

First Submitted

Initial submission to the registry

April 15, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

October 20, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

4.3 years

First QC Date

April 15, 2022

Last Update Submit

February 3, 2026

Conditions

InsomniaSuicidal IdeationSuicide, Attempted

Keywords

Sleep Initiation and Maintenance DisordersSuicidal IdeationAdolescentMotivational InterviewingCognitive Behavioral TherapyTelemedicine

Outcome Measures

Primary Outcomes (9)

  • Change from baseline in suicidality on the Ask Suicide-Screening Questions (ASQ) questionnaire at 2 months and 4 months

    The ASQ is a validated 4-item screen for suicidal ideation and behavior (yes/no) administered via interview. There is an additional 5th item if there is endorsement of one or more of the previous items.

    Baseline, 2-months & 4-months

  • Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 2 months and 4 months

    The C-SSRS is a validated, semi-structured interview that assesses both suicidal behavior and suicidal ideation (yes/no, frequency), with flexible timepoints and multiple informants depending on administrator purpose and need.

    Baseline, 2-months & 4-months

  • Change from baseline in lethality/medical damage of suicide attempt on the Medical Damage Lethality Rating Scale (MD-LRS) at 2 months and 4 months

    The MD-LRS is a validated assessment of the degree of actual (6-point scale; 0=none; 5=death) or potential lethality (physical damage to the body; 3-point scale; 0=Behavior not likely to result in injury; 2=Behavior likely to result in injury despite available medical care) of a suicide attempt. The MD-LRS is completed by the interviewer based on details provided on the C-SSRS.

    Baseline, 2-months & 4-months

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

    The SIS is a validated 15-item interview measure that assesses all relevant behavioral and circumstantial aspects surrounding an actual suicide attempt, including plans, preparation elements, and conception of the lethality of the chosen method (3-point scale; 0=no or less intent; 2=more intent).

    Baseline, 2-months & 4-months

  • Change from baseline in suicidal ideation severity on the Suicidal Ideation Questionnaire-Junior (SIQ-JR) at 2 months and 4 months

    The SIQ-JR is a 15-item modified version of the 30-item Suicidal Ideation Questionnaire. The SIQ-JR is a validated self-report measure of suicidal ideation severity in adolescents (7-point scale; 0="I never had this thought"; 6="Almost every day").

    Baseline, 2-months & 4-months

  • Change from baseline in aspects of insomnia on the Adolescent Sleep Wake Scale (ASWS) at 2 months and 4 months

    The ASWS is a 28-item, validated, self-report measure that assesses sleep onset insomnia, sleep maintenance insomnia, and morning awakenings (6-point scale; 0=Never; 5=Always).

    Baseline, 2-months & 4-months

  • Change from baseline in sleep hygiene behaviors on the Adolescent Sleep Hygiene Scale (ASHS) at 2 months and 4 months

    The ASHS is a validated, self-report, 28-item measure assessing sleep-inhibiting (e.g., caffeine use, technology use) and sleep-facilitating behaviors (6-point scale; 0=Never; 5=Always).

    Baseline, 2-months & 4-months

  • Change from baseline in adverse effects of disordered sleep on the on the Sleep-Disordered Breathing Subscale (SDBS) of the Pediatric Sleep Questionnaire (PSQ) at 2 months and 4 months

    The participating parent will complete the 7-item SDBS of the PSQ, which assesses potential behavioral and physical adverse effects of sleep disorders (yes, no, or don't know).

    Baseline, 2-months & 4-months

  • Change from baseline in typical hours slept on item 4 of the BEARS Sleep Screening Tool Adapted - Adolescents measure at 2 months and 4 months

    The BEARS is a validated self-report measure assessing bedtime problems (B), excessive daytime sleepiness (E), awakenings during the night (A), and regularity and duration of sleep (R). Question 4 (R) asks how many hours the adolescent sleeps on a typical week night and typical weekend night.

    Baseline, 2-months & 4-months

Secondary Outcomes (10)

  • General Information Sheet (GIS)

    Baseline

  • Child and Adolescent Symptom Inventory-5 (CASI-5)

    Baseline

  • Change from baseline in psychosocial functioning and impairment on the Columbia Impairment Scale (CIS) at 2 months and 4 months

    Baseline, 2-months & 4-months

  • Drug Use Screening Inventory (DUSI)

    Baseline

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

    Baseline, 2-months & 4-months

  • +5 more secondary outcomes

Study Arms (2)

TAILOR

EXPERIMENTAL

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.

Behavioral: TAILOR

Enhanced Usual Care (EUC)

OTHER

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.

Other: Enhanced Usual Care

Interventions

TAILORBEHAVIORAL

The first TAILOR session will assess existing sleep problems from both the adolescent's and parent/legal guardian's perspectives, concluding with offering a CBT strategy to try. Session 2 will involve getting feedback from the family on that specific strategy and then offering additional CBT strategies. The remaining sessions will be devoted to refining the use of CBT strategies. MI will be integrated as the communication style throughout, including reflective listening, rolling with resistance, and showing deference to the family's ultimate decisions. The interventionist will also use the "elicit-provide-elicit" approach from MI. The interventionist will elicit the family's own ideas for improving the adolescent's sleep, ask for permission to provide his/her own suggestions, and then gauge the family's reactions to those suggestions, versus simply recommending a CBT strategy and problem-solving barriers to implementation.

TAILOR
Enhanced Usual CareOTHER

The study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary.

Also known as: EUC
Enhanced Usual Care (EUC)

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Related Publications (85)

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Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSuicidal IdeationSuicide, Attempted

Interventions

Tailor protein, Drosophila

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Jeff Bridge, Ph.D.

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Cannon, MA, MS

CONTACT

614-355-0578elizabeth.cannon@nationwidechildrens.org

Kendra Heck, MPH

CONTACT

614-355-3433kendra.heck@nationwidechildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: One hundred ninety eligible youths aged 11 years, 0 months, to 18 years, 11 months, inclusive at time of consent, with sleep problems (within the past month) and suicidal ideation (within the past 90 days) will be randomized to either TAILOR (n=95 eligible participants) or to EUC (n=95 eligible participants).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Center for Suicide Prevention and Research

Study Record Dates

First Submitted

April 15, 2022

First Posted

May 25, 2022

Study Start

October 20, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Beginning 3 months and ending 5 years following publication.
Access Criteria
Researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Proposals should be directed to jeff.bridge@nationwidechildrens.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years after publication at a web address to be determined.

Locations

US(1)