TAILOR for Adolescent Insomnia and Suicidal Behavior
This study is testing a program called TAILOR (Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior). TAILOR uses strategies like Cognitive Behavioral Therapy (CBT) to help teenagers who have trouble sleeping and are at risk for suicidal behavior. The study will compare TAILOR to Enhanced Usual Care, which involves suicide risk screening and safety planning. We want to see if TAILOR can improve sleep and reduce suicidal thoughts and behaviors in adolescents aged 11 to 18 who are patients at Nationwide Children's Hospital. Success would mean a reduction in suicidal thoughts and behaviors, and an improvement in sleep, as measured by questionnaires over 2 and 4 months.
- Study design
- This interventional study plans to enroll 235 participants. It compares two approaches: TAILOR and Enhanced Usual Care.
- What's involved
- Participants will have sessions where sleep problems are assessed and CBT strategies are offered. Suicide risk screening and safety planning will also be conducted.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for changes in suicidality and suicidal ideation/behavior at 2 months and 4 months.
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Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jeff Bridge, Ph.D. · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital
Who to contact
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What this trial measures
- Change from baseline in suicidality on the Ask Suicide-Screening Questions (ASQ) questionnaire at 2 months and 4 monthsBaseline, 2-months & 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.
- Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 2 months and 4 monthsBaseline, 2-months & 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.
- Change from baseline in lethality/medical damage of suicide attempt on the Medical Damage Lethality Rating Scale (MD-LRS) at 2 months and 4 monthsBaseline, 2-months & 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.
- Change from baseline in aspects of suicide intent on the Suicide Intent Scale (SIS) at 2 months and 4 monthsBaseline, 2-months & 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).
- Change from baseline in suicidal ideation severity on the Suicidal Ideation Questionnaire-Junior (SIQ-JR) at 2 months and 4 monthsBaseline, 2-months & 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").
- Change from baseline in aspects of insomnia on the Adolescent Sleep Wake Scale (ASWS) at 2 months and 4 monthsBaseline, 2-months & 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).
- Change from baseline in sleep hygiene behaviors on the Adolescent Sleep Hygiene Scale (ASHS) at 2 months and 4 monthsBaseline, 2-months & 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).
- 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 monthsBaseline, 2-months & 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).
- Change from baseline in typical hours slept on item 4 of the BEARS Sleep Screening Tool Adapted - Adolescents measure at 2 months and 4 monthsBaseline, 2-months & 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.