Clinical trial NCT05390918: Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior
Official title: Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Suicidal Ideation
Suicide, Attempted
Keywords: Sleep Initiation and Maintenance Disorders
Suicidal Ideation
Adolescent
Motivational Interviewing
Cognitive Behavioral Therapy
Telemedicine
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2022-05-25
Enrollment: 190
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

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.

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) 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in suicidality on the Ask Suicide-Screening Questions (ASQ) questionnaire at 2 months and 4 months
timeFrame: Baseline, 2-months & 4-months
measure: Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 2 months and 4 months
timeFrame: Baseline, 2-months & 4-months
measure: 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
timeFrame: Baseline, 2-months & 4-months
measure: Change from baseline in aspects of suicide intent on the Suicide Intent Scale (SIS) at 2 months and 4 months
timeFrame: Baseline, 2-months & 4-months
measure: Change from baseline in suicidal ideation severity on the Suicidal Ideation Questionnaire-Junior (SIQ-JR) at 2 months and 4 months
timeFrame: Baseline, 2-months & 4-months
measure: Change from baseline in aspects of insomnia on the Adolescent Sleep Wake Scale (ASWS) at 2 months and 4 months
timeFrame: Baseline, 2-months & 4-months
measure: Change from baseline in sleep hygiene behaviors on the Adolescent Sleep Hygiene Scale (ASHS) at 2 months and 4 months
timeFrame: Baseline, 2-months & 4-months
measure: 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
timeFrame: Baseline, 2-months & 4-months
measure: 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
timeFrame: Baseline, 2-months & 4-months
Secondary outcomes:
measure: General Information Sheet (GIS)
timeFrame: Baseline
measure: Child and Adolescent Symptom Inventory-5 (CASI-5)
timeFrame: Baseline
measure: Change from baseline in psychosocial functioning and impairment on the Columbia Impairment Scale (CIS) at 2 months and 4 months
timeFrame: Baseline, 2-months & 4-months
measure: Drug Use Screening Inventory (DUSI)
timeFrame: Baseline
measure: Change from baseline in health risk behaviors on the 2017 National Youth Risk Behavior Survey at 2 months and 4 months
timeFrame: Baseline, 2-months & 4-months
measure: Modified version of The Service Assessment for Children and Adolescents (SACA Modified)
timeFrame: Baseline
measure: Biological family history of suicidal behavior on the Family History Screen (FHS)
timeFrame: Baseline
measure: Motivation to change sleep-related behavior on the Sleep Motivation Question at Baseline
timeFrame: Baseline
measure: Change from baseline in parent-child conflict on the Conflict Behavior Questionnaire (CBQ) at 2 months and 4 months
timeFrame: Baseline, 2-months & 4-months
measure: Client's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 4-months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Jeff Bridge, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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