Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior (TAILOR)

Jeff Bridge

Status: Enrolling

Conditions: Suicide, Attempted; Suicidal Ideation; Insomnia

Treatments: Behavioral: TAILOR; Other: Enhanced Usual Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05390918

STUDY00002083

0920-1301 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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) or to EUC (n=95). 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

TAILOR

Experimental group

Description:

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.

Treatment:

Behavioral: TAILOR

Enhanced Usual Care (EUC)

Other group

Description:

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.

Treatment:

Other: Enhanced Usual Care