Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior
NCT ID: NCT05390918
Last Updated: 2026-02-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
235 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-10-20
Study Completion Date
2027-02-28
Brief Summary
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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.
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Detailed Description
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This study will test the effectiveness of TAILOR, a multifaceted intervention designed to reduce sleep problems and markers of suicide risk in adolescents. The TAILOR intervention will incorporate 3 different empirically-based behavioral-change approaches for addressing adult sleep and/or adolescent non-sleep behaviors, including Cognitive Behavioral Therapy, Motivational Interviewing, and voice- or video call-based assistance with adolescents with recent suicidal ideation and either no history of suicide attempt or suicide attempt at least 3 months ago.
Hypotheses:
1. Adolescents receiving the TAILOR intervention will have better sleep according to both youth and parent/Legal Guardian (P/LG) reports relative to adolescents in the Enhanced Usual Care (EUC) condition at 2 and 4 months.
2. The TAILOR intervention will result in significant reductions in suicidal ideation relative to the EUC condition at 4 months.
Exploratory secondary aims:
1. Determine if (a) the response to the TAILOR intervention varies by gender, race/ ethnicity, medication status, or type of insomnia (e.g., difficulties falling versus staying asleep) and (b) TAILOR impacts other health risk behavior domains besides sleep and suicidal ideation.
2. Assess if improved sleep at 2 months mediates the relationship between receiving the TAILOR intervention and lower suicidal ideation at 4 months.
3. Test whether TAILOR is superior to EUC in reducing suicide attempts at 4 months.
One hundred ninety 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). Suicidal ideation refers to thoughts about killing oneself, as well as contemplation of the when, where, and how of suicide. As such, suicidal ideation is considered proximal on a spectrum of severity for suicidal behaviors ranging from ideation to threats, to attempts, and to suicide. A major goal of TAILOR is thus to eliminate or at the very least minimize suicidal ideation.
Study outcomes will be assessed at 2- and 4- months post-randomization by an independent evaluator blind to participant status. Primary study outcomes will be sleep problems and suicidal ideation, major modifiable markers of suicide risk. All randomized participants will be followed for the duration of the study regardless of treatment compliance or clinical outcomes according to the protocol assessment, and main study analyses will follow an intent-to-treat (ITT) approach.
Hypotheses:
1. Adolescents receiving the TAILOR intervention will have better sleep according to both youth and parent/Legal Guardian (P/LG) reports relative to adolescents in the Enhanced Usual Care (EUC) condition at 2 and 4 months.
2. The TAILOR intervention will result in significant reductions in suicidal ideation relative to the EUC condition at 4 months.
Exploratory secondary aims:
1. Determine if (a) the response to the TAILOR intervention varies by gender, race/ ethnicity, medication status, or type of insomnia (e.g., difficulties falling versus staying asleep) and (b) TAILOR impacts other health risk behavior domains besides sleep and suicidal ideation.
2. Assess if improved sleep at 2 months mediates the relationship between receiving the TAILOR intervention and lower suicidal ideation at 4 months.
3. Test whether TAILOR is superior to EUC in reducing suicide attempts at 4 months.
One hundred ninety 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). Suicidal ideation refers to thoughts about killing oneself, as well as contemplation of the when, where, and how of suicide. As such, suicidal ideation is considered proximal on a spectrum of severity for suicidal behaviors ranging from ideation to threats, to attempts, and to suicide. A major goal of TAILOR is thus to eliminate or at the very least minimize suicidal ideation.
Study outcomes will be assessed at 2- and 4- months post-randomization by an independent evaluator blind to participant status. Primary study outcomes will be sleep problems and suicidal ideation, major modifiable markers of suicide risk. All randomized participants will be followed for the duration of the study regardless of treatment compliance or clinical outcomes according to the protocol assessment, and main study analyses will follow an intent-to-treat (ITT) approach.
Conditions
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Insomnia
Suicidal Ideation
Suicide, Attempted
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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).
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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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.
Group Type
EXPERIMENTAL
TAILOR
Intervention Type
BEHAVIORAL
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 (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.
Group Type
OTHER
Enhanced Usual Care
Intervention Type
OTHER
The study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary.
Interventions
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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.
Intervention Type
BEHAVIORAL
Enhanced Usual Care
The study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary.
Intervention Type
OTHER
Other Intervention Names
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EUC
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Minimum Eligible Age
11 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Centers for Disease Control and Prevention
FED
Sponsor Role
collaborator
Jeff Bridge
OTHER
Sponsor Role
lead
Responsible Party
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Jeff Bridge
Director, Center for Suicide Prevention and Research
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Jeff Bridge, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Related Links
Access external resources that provide additional context or updates about the study.
https://www.cdc.gov/injury/wisqars/LeadingCauses.html
WISQARS National and Regional, Ages 12-17 Years, 2015
https://reporter.nih.gov/
National Institutes of Health Research Portfolio Online Reporting Tool, 1/13/2016
http://www.cdc.gov/HealthyYouth/yrbs/index.htm
Youth Risk Behavior Surveillance, 2013
https://www.sleepfoundation.org/professionals/sleep-america-polls
Sleep in America Poll
http://www.motivationalinterview.org
Motivational Interviewing Network of Trainers: Excellence in Motivational Interviewing
https://clinicaltrials.gov/ct2/show/NCT02248675
BBTI for SI
https://clinicaltrials.gov/ct2/show/NCT01770587
A Sleep-Oriented Intervention for Suicidal Behaviors
https://clinicaltrials.gov/ct2/show/NCT01689909
Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT)
http://en.wikipedia.org/wiki/Columbus,_Ohio_Metropolitan_Area
Columbus, OH metropolitan area
http://www.cdc.gov/healthyyouth/yrbs/questionnaire_rationale.htm
2015 National Youth Risk Behavior Survey Questionnaire
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0920-1301
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00002083
Identifier Type: -
Identifier Source: org_study_id
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