Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior
概览
- 阶段
- 不适用
- 干预措施
- TAILOR
- 疾病 / 适应症
- Insomnia
- 发起方
- Jeff Bridge
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Change from baseline in sleep hygiene behaviors on the Adolescent Sleep Hygiene Scale (ASHS) at 2 months and 4 months
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
Jeff Bridge
Director, Center for Suicide Prevention and Research
Nationwide Children's Hospital
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: TAILOR
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.
干预措施: Enhanced Usual Care
结局指标
主要结局
Change from baseline in sleep hygiene behaviors on the Adolescent Sleep Hygiene Scale (ASHS) at 2 months and 4 months
时间窗: Baseline, 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 aspects of suicide intent on the Suicide Intent Scale (SIS) at 2 months and 4 months
时间窗: Baseline, 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 aspects of insomnia on the Adolescent Sleep Wake Scale (ASWS) at 2 months and 4 months
时间窗: Baseline, 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 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
时间窗: Baseline, 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 months
时间窗: Baseline, 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.
Change from baseline in suicidality on the Ask Suicide-Screening Questions (ASQ) questionnaire at 2 months and 4 months
时间窗: Baseline, 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 months
时间窗: Baseline, 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 suicidal ideation severity on the Suicidal Ideation Questionnaire-Junior (SIQ-JR) at 2 months and 4 months
时间窗: Baseline, 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 lethality/medical damage of suicide attempt on the Medical Damage Lethality Rating Scale (MD-LRS) at 2 months and 4 months
时间窗: Baseline, 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.
次要结局
- Modified version of The Service Assessment for Children and Adolescents (SACA Modified)(Baseline)
- General Information Sheet (GIS)(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)
- Child and Adolescent Symptom Inventory-5 (CASI-5)(Baseline)
- Biological family history of suicidal behavior on the Family History Screen (FHS)(Baseline)
- Motivation to change sleep-related behavior on the Sleep Motivation Question at Baseline(Baseline)
- 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)
- Change from baseline in parent-child conflict on the Conflict Behavior Questionnaire (CBQ) at 2 months and 4 months(Baseline, 2-months & 4-months)
- Client's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)(4-months)