Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior

Study Overview
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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.

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: 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. The TAILOR intervention will result in significant reductions in suicidal ideation relative to the EUC condition at 4 months. Exploratory secondary aims: 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. Assess if improved sleep at 2 months mediates the relationship between receiving the TAILOR intervention and lower suicidal ideation at 4 months. 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.

Official Title
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Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior

Conditions
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Insomnia, Suicidal Ideation, Suicide, Attempted

Intervention / Treatment
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* Behavioral: TAILOR
* Other: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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 Chronic physical pain contributing to sleep problems 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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAILOR<br>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. | Behavioral: TAILOR<br>* 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.<br>|
| Other: Enhanced Usual Care (EUC)<br>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. | Other: Enhanced Usual Care<br>* The study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary.<br>* Other names: EUC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in suicidality on the Ask Suicide-Screening Questions (ASQ) questionnaire at 2 months and 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. | 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 | 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. | 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 | 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. | 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 | 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). | 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 | 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). | 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 | 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). | 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 | 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). | 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 | 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). | 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 | 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. | Baseline, 2-months & 4-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Information Sheet (GIS) | The GIS is used to assess age, race, gender, religion, family constellation, living arrangement, school placement, socio-economic status (SES), as well as addresses and telephone numbers of 3 relatives, which may be used to locate subjects for study retention. | Baseline | 
| Child and Adolescent Symptom Inventory-5 (CASI-5) | The CASI-5 is a behavioral rating scale containing 160 items (4 point scale; 0=Never; 3=Very Often) based on DSM-5 criteria that screens for the most common child and adolescent psychiatric disorders, to be completed by the parent. It will be used to provide a circumscribed measure of psychopathology to characterize the sample. | Baseline | 
| Change from baseline in psychosocial functioning and impairment on the Columbia Impairment Scale (CIS) at 2 months and 4 months | The CIS is a valid 13-item child- and parent- report measure of psychosocial impairment with good internal consistency and test-retest reliability. | Baseline, 2-months & 4-months | 
| Drug Use Screening Inventory (DUSI) | The DUSI is a 15-item self-report measure of polysubstance abuse that measures frequency of alcohol and substance use (5-point scale; 0=0 Times; 5= More than 20 Times). The DUSI will be used to characterize baseline substance use in all adolescents via both parent and adolescent report. | Baseline | 
| Change from baseline in health risk behaviors on the 2017 National Youth Risk Behavior Survey at 2 months and 4 months | A subset of questions from the CDC's 2017 National Youth Risk Behavior Survey will be used to assess the following health risk behaviors: physical fighting, tobacco use, electronic vapor product use, alcohol use and binge drinking, body weight, physical activity, and school grades. | Baseline, 2-months & 4-months | 
| Modified version of The Service Assessment for Children and Adolescents (SACA Modified) | The parent participating in the study will be asked questions related to any treatment or help the child participant has received for emotional, behavioral, or drug or alcohol problems at baseline. | Baseline | 
| Biological family history of suicidal behavior on the Family History Screen (FHS) | Two items from the validated FHS will be administered to the parent participant assessing family history of suicidal behavior within their child's biological parents and full siblings. | Baseline | 
| Motivation to change sleep-related behavior on the Sleep Motivation Question at Baseline | One question will be asked to gauge both the parent's and adolescent's motivation to change sleep-related behavior on a scale of 1-10 at Baseline. | Baseline | 
| Change from baseline in parent-child conflict on the Conflict Behavior Questionnaire (CBQ) at 2 months and 4 months | The CBQ is a 20-item true/false scale that assesses general conflict between parents and their children. The CBQ is completed by parents and adolescents. The CBQ has adequate internal consistency and discriminatory validity between distressed and non-distressed families. | Baseline, 2-months & 4-months | 
| Client's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8) | The CSQ-8 is an 8-item, easily scored and administered measurement that is designed to measure client satisfaction with services. The items for the CSQ-8 were selected on the basis of ratings by mental health professionals of items that could be related to client satisfaction and by subsequent factor analysis. The CSQ-8 is unidimensional, yielding a homogeneous estimate of general satisfaction with services. The CSQ-8 has been extensively studied, and while it is not necessarily a measure of a client's perceptions of gain from treatment. or outcome, it does elicit the client's perspective on the value of services received. | 4-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Initiation and Maintenance Disorders, Suicidal Ideation, Adolescent, Motivational Interviewing, Cognitive Behavioral Therapy, Telemedicine