We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05390918
Recruitment Status : Recruiting
First Posted : May 25, 2022
Last Update Posted : October 27, 2022
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Jeff Bridge, Nationwide Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Insomnia Suicidal Ideation Suicide, Attempted Behavioral: TAILOR Other: Enhanced Usual Care Not Applicable

Detailed 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 but without a history of suicide attempt.

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 12 years, 0 months, to 17 years, 6 months, inclusive at time of consent, with sleep problems (within the past 2 weeks) 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One hundred ninety youths aged 12 years, 0 months, to 17 years, 6 months, inclusive at time of consent, with sleep problems (within the past 2 weeks) and suicidal ideation (within the past 90 days) will be randomized to either TAILOR (n=95) or to EUC (n=95).
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior
Actual Study Start Date : October 20, 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: 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.
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.

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




Primary Outcome Measures :
  1. Change from baseline in suicidality on the Ask Suicide-Screening Questions (ASQ) questionnaire at 2 months and 4 months [ Time Frame: 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.

  2. Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 2 months and 4 months [ Time Frame: 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.

  3. 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 [ Time Frame: 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.

  4. Change from baseline in aspects of suicide intent on the Suicide Intent Scale (SIS) at 2 months and 4 months [ Time Frame: 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).

  5. Change from baseline in suicidal ideation severity on the Suicidal Ideation Questionnaire-Junior (SIQ-JR) at 2 months and 4 months [ Time Frame: 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").

  6. Change from baseline in aspects of insomnia on the Adolescent Sleep Wake Scale (ASWS) at 2 months and 4 months [ Time Frame: 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).

  7. Change from baseline in sleep hygiene behaviors on the Adolescent Sleep Hygiene Scale (ASHS) at 2 months and 4 months [ Time Frame: 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).

  8. 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 [ Time Frame: 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).

  9. 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 [ Time Frame: 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.


Secondary Outcome Measures :
  1. General Information Sheet (GIS) [ Time Frame: Baseline ]
    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.

  2. Child and Adolescent Symptom Inventory-5 (CASI-5) [ Time Frame: Baseline ]
    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.

  3. Change from baseline in psychosocial functioning and impairment on the Columbia Impairment Scale (CIS) at 2 months and 4 months [ Time Frame: Baseline, 2-months & 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.

  4. Drug Use Screening Inventory (DUSI) [ Time Frame: Baseline ]
    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.

  5. Change from baseline in health risk behaviors on the 2017 National Youth Risk Behavior Survey at 2 months and 4 months [ Time Frame: Baseline, 2-months & 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.

  6. Modified version of The Service Assessment for Children and Adolescents (SACA Modified) [ Time Frame: Baseline ]
    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.

  7. Biological family history of suicidal behavior on the Family History Screen (FHS) [ Time Frame: Baseline ]
    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.

  8. Motivation to change sleep-related behavior on the Sleep Motivation Question at Baseline [ Time Frame: Baseline ]
    One question will be asked to guage both the parent's and adolescent's motivation to change sleep-related behavior on a scale of 1-10 at Baseline.

  9. Change from baseline in parent-child conflict on the Conflict Behavior Questionnaire (CBQ) at 2 months and 4 months [ Time Frame: Baseline, 2-months & 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Nationwide Children's Hospital patients
  • Between the ages of 12 years, 0 months, and 17 years, 6 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:

  • History of suicide attempt
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05390918


Contacts
Layout table for location contacts
Contact: Elizabeth Cannon, MA, MS 614-355-0578 elizabeth.cannon@nationwidechildrens.org
Contact: Kendra Heck, MPH 614-355-3433 kendra.heck@nationwidechildrens.org

Locations
Layout table for location information
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Elizabeth Cannon, MA, MS    614-355-0578    elizabeth.cannon@nationwidechildrens.org   
Contact: Kendra Heck, MPH    614-355-3433    kendra.heck@nationwidechildrens.org   
Sponsors and Collaborators
Jeff Bridge
Centers for Disease Control and Prevention
Investigators
Layout table for investigator information
Principal Investigator: Jeff Bridge, Ph.D. Nationwide Children's Hospital
Additional Information:
Publications:
Lewinsohn PM, Rohde P, Seeley JR. Adolescent suicidal ideation and attempts: prevalence, risk factors, and clinical implications. Clinical Psychology Science and Practice. 1996;3:25-36.
Reynolds W, Mazza J. Assessment of suicidal ideation in inner-city children and young adolescents: reliability and validity of the Suicidal Ideation Questionnaire-JR. School Psychology Review. 1999;28:17-30.
Bird H, Shaffer D, Fisher P, et al. The Columbia Impairment Scale (CIS): Pilot findings on a measure of global impairment for children and adolescents. International Journal of Methods in Psychiatric Research. 1993;3:167-176.
Tarter RE, Kirisci L, Mezzich AC. The drug use screening inventory: School adjustment correlates of substance abuse. Measurement and Evaluation in Counseling and Development. 1996;29:25-34.
Lavori P, Dawson R. Designing for intent-to-treat. Drug Information Journal. 2001;35:1079-1086.

Layout table for additonal information
Responsible Party: Jeff Bridge, Director, Center for Suicide Prevention and Research, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT05390918    
Other Study ID Numbers: STUDY00002083
0920-1301 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
First Posted: May 25, 2022    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Beginning 3 months and ending 5 years following publication.
Access Criteria: Researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Proposals should be directed to jeff.bridge@nationwidechildrens.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years after publication at a web address to be determined.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeff Bridge, Nationwide Children's Hospital:
Sleep Initiation and Maintenance Disorders
Suicidal Ideation
Adolescent
Motivational Interviewing
Cognitive Behavioral Therapy
Telemedicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Suicide
Suicidal Ideation
Suicide, Attempted
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Self-Injurious Behavior
Behavioral Symptoms