Recruiting

Insomnia

Sponsor:

Jeff Bridge

Code:

NCT05390918

Conditions

Insomnia

Suicidal Ideation

Suicide, Attempted

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

Interventions

TAILOR

Enhanced Usual Care

Study Details

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.

Conditions

Insomnia

Suicidal Ideation

Suicide, Attempted

Study ID

NCT05390918

Start date

Oct 20, 2022

Status verified date

Jan, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

235 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: TAILOR

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.

other: Enhanced Usual Care (EUC)

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.

Interventions

TAILOR

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.

Enhanced Usual Care

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

Primary outcome measure

  • Change from baseline in suicidality on the Ask Suicide-Screening Questions (ASQ) questionnaire at 2 months and 4 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, 2-months & 4-months ]

Central Contacts and Locations

Central contacts

Elizabeth Cannon, MA, MS

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

Kendra Heck, MPH

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

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Elizabeth Cannon, MA, MS

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

Kendra Heck, MPH

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

More Information

Sponsor

Jeff Bridge

Last update posted

Feb 5, 2026

Last verified

Jan, 2026

Keywords

  • Sleep Initiation and Maintenance Disorders
  • Suicidal Ideation
  • Adolescent
  • Motivational Interviewing
  • Cognitive Behavioral Therapy
  • Telemedicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jeff Bridge on 2026-02-05.