Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior

Insomnia Clinical Trial

— TAILOR  

Official title:

Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390918
• Other study ID #: STUDY00002083
• Secondary ID: 0920-1301
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: Elizabeth Cannon, MA, MS
• Phone: 614-355-0578
• Email: elizabeth.cannon[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders
• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• 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.

Other:
• Enhanced Usual Care
The study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Jeff Bridge	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

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* Note: There are 85 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   2015 National Youth Risk Behavior Survey Questionnaire
•   A Sleep-Oriented Intervention for Suicidal Behaviors
•   BBTI for SI
•   Columbus, OH metropolitan area
•   Motivational Interviewing Network of Trainers: Excellence in Motivational Interviewing
•   National Institutes of Health Research Portfolio Online Reporting Tool, 1/13/2016
•   Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT)
•   Sleep in America Poll
•   WISQARS National and Regional, 2013
•   WISQARS National and Regional, Ages 12-17 Years, 2015
•   Youth Risk Behavior Surveillance, 2013