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InsomniaTAILORNCT05390918

Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior

A study testing TAILOR in people with Insomnia and Suicidal Ideation, run by Jeff Bridge at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 11 to 18 years
Conditions the study is for
Insomnia, Suicidal Ideation, Suicide, Attempted
What is being tested?
TAILOR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
1 siteUnited States
Study dates
20 Oct 2022to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elizabeth Cannon, MA, MS contact

614-355-0578

elizabeth.cannon@nationwidechildrens.org

Kendra Heck, MPH contact

614-355-3433

kendra.heck@nationwidechildrens.org

United States1 site, 1 recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Elizabeth Cannon, MA, MS, 614-355-0578, elizabeth.cannon@nationwidechildrens.org

    Kendra Heck, MPH, 614-355-3433, kendra.heck@nationwidechildrens.org

    Recruiting

Other trials in United States

About this study

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.

Read the 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 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.

Being tested
TAILOR, Enhanced Usual Care
Keywords
Sleep Initiation and Maintenance Disorders, Suicidal Ideation, Adolescent, Motivational Interviewing, Cognitive Behavioral Therapy, Telemedicine
Medical subject headings
Sleep Initiation and Maintenance Disorders, Suicidal Ideation, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAILORBehavioural

    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 CareOther

    Also called EUC

    The study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary.

Study groups in NCT05390918
Study groupRoleWhat they receive
TAILORExperimentalHalf 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.
Receives: Behavioral: TAILOR
Enhanced Usual Care (EUC)OtherHalf 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.
Receives: Other: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 2-months & 4-months

  2. 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.

    Measured: Baseline, 2-months & 4-months

  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

    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.

    Measured: Baseline, 2-months & 4-months

  4. 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).

    Measured: Baseline, 2-months & 4-months

  5. 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").

    Measured: Baseline, 2-months & 4-months

  6. 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).

    Measured: Baseline, 2-months & 4-months

  7. 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).

    Measured: Baseline, 2-months & 4-months

  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

    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).

    Measured: Baseline, 2-months & 4-months

  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

    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.

    Measured: Baseline, 2-months & 4-months

Secondary outcomes (10)

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline, 2-months & 4-months

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline, 2-months & 4-months

  6. 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.

    Measured: Baseline

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: Baseline

  9. 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.

    Measured: Baseline, 2-months & 4-months

  10. 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.

    Measured: 4-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start20 Oct 2022
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
One hundred ninety eligible 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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
235 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05390918
Sponsor's protocol ID
STUDY00002083
Other IDs
0920-1301
Acronym
TAILOR
Status last verified
Jan 2026
First submitted
15 Apr 2022
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification.

Publications

  • Bridge JA, Greenhouse JB, Weldon AH, Campo JV, Kelleher KJ. Suicide trends among youths aged 10 to 19 years in the United States, 1996-2005. JAMA. 2008 Sep 3;300(9):1025-6. doi: 10.1001/jama.300.9.1025. No abstract available.

    PubMed 18768413

  • Sullivan EM, Annest JL, Simon TR, Luo F, Dahlberg LL; Centers for Disease Control and Prevention (CDC). Suicide trends among persons aged 10-24 years--United States, 1994-2012. MMWR Morb Mortal Wkly Rep. 2015 Mar 6;64(8):201-5.

    PubMed 25742379

  • Institute of Medicine (US) Committee on Pathophysiology and Prevention of Adolescent and Adult Suicide; Goldsmith SK, Pellmar TC, Kleinman AM, Bunney WE, editors. Reducing Suicide: A National Imperative. Washington (DC): National Academies Press (US); 2002. Available from http://www.ncbi.nlm.nih.gov/books/NBK220939/

    PubMed 25057611

  • Campo JV. Suicide prevention: time for 'zero tolerance'. Curr Opin Pediatr. 2009 Oct;21(5):611-2. doi: 10.1097/MOP.0b013e3283306912. No abstract available.

    PubMed 19726992

  • 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.

  • Goldston DB, Daniel SS, Reboussin DM, Reboussin BA, Frazier PH, Kelley AE. Suicide attempts among formerly hospitalized adolescents: a prospective naturalistic study of risk during the first 5 years after discharge. J Am Acad Child Adolesc Psychiatry. 1999 Jun;38(6):660-71. doi: 10.1097/00004583-199906000-00012.

    PubMed 10361783

  • Harrington R, Bredenkamp D, Groothues C, Rutter M, Fudge H, Pickles A. Adult outcomes of childhood and adolescent depression. III. Links with suicidal behaviours. J Child Psychol Psychiatry. 1994 Oct;35(7):1309-19. doi: 10.1111/j.1469-7610.1994.tb01236.x.

    PubMed 7806612

  • Reinherz HZ, Tanner JL, Berger SR, Beardslee WR, Fitzmaurice GM. Adolescent suicidal ideation as predictive of psychopathology, suicidal behavior, and compromised functioning at age 30. Am J Psychiatry. 2006 Jul;163(7):1226-32. doi: 10.1176/ajp.2006.163.7.1226.

    PubMed 16816228

  • Nock MK, Green JG, Hwang I, McLaughlin KA, Sampson NA, Zaslavsky AM, Kessler RC. Prevalence, correlates, and treatment of lifetime suicidal behavior among adolescents: results from the National Comorbidity Survey Replication Adolescent Supplement. JAMA Psychiatry. 2013 Mar;70(3):300-10. doi: 10.1001/2013.jamapsychiatry.55.

    PubMed 23303463

  • Bernert RA, Kim JS, Iwata NG, Perlis ML. Sleep disturbances as an evidence-based suicide risk factor. Curr Psychiatry Rep. 2015 Mar;17(3):554. doi: 10.1007/s11920-015-0554-4.

    PubMed 25698339

  • Bernert RA, Turvey CL, Conwell Y, Joiner TE Jr. Association of poor subjective sleep quality with risk for death by suicide during a 10-year period: a longitudinal, population-based study of late life. JAMA Psychiatry. 2014 Oct;71(10):1129-37. doi: 10.1001/jamapsychiatry.2014.1126.

    PubMed 25133759

  • Pigeon WR, Pinquart M, Conner K. Meta-analysis of sleep disturbance and suicidal thoughts and behaviors. J Clin Psychiatry. 2012 Sep;73(9):e1160-7. doi: 10.4088/JCP.11r07586.

    PubMed 23059158

  • Malik S, Kanwar A, Sim LA, Prokop LJ, Wang Z, Benkhadra K, Murad MH. The association between sleep disturbances and suicidal behaviors in patients with psychiatric diagnoses: a systematic review and meta-analysis. Syst Rev. 2014 Feb 25;3:18. doi: 10.1186/2046-4053-3-18.

    PubMed 24568642

  • Koyawala N, Stevens J, McBee-Strayer SM, Cannon EA, Bridge JA. Sleep problems and suicide attempts among adolescents: a case-control study. Behav Sleep Med. 2015;13(4):285-95. doi: 10.1080/15402002.2014.888655. Epub 2014 Mar 21.

    PubMed 24654933

  • Goldstein TR, Bridge JA, Brent DA. Sleep disturbance preceding completed suicide in adolescents. J Consult Clin Psychol. 2008 Feb;76(1):84-91. doi: 10.1037/0022-006X.76.1.84.

    PubMed 18229986

Questions about this trial

What is this clinical trial studying?

A study testing TAILOR in people with Insomnia and Suicidal Ideation, run by Jeff Bridge at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth Cannon, MA, MS (614-355-0578, elizabeth.cannon@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05390918, which also lists 85 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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