Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change from baseline in suicidality on the Ask Suicide-Screening Questions (ASQ) questionnaire at 2 months and 4 months [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, 2-months & 4-months]

Вторичные конечные точки (10)

• General Information Sheet (GIS) [Срок оценки: Baseline]
• Child and Adolescent Symptom Inventory-5 (CASI-5) [Срок оценки: Baseline]
• Change from baseline in psychosocial functioning and impairment on the Columbia Impairment Scale (CIS) at 2 months and 4 months [Срок оценки: Baseline, 2-months & 4-months]
• Drug Use Screening Inventory (DUSI) [Срок оценки: Baseline]
• Change from baseline in health risk behaviors on the 2017 National Youth Risk Behavior Survey at 2 months and 4 months [Срок оценки: Baseline, 2-months & 4-months]
• Modified version of The Service Assessment for Children and Adolescents (SACA Modified) [Срок оценки: Baseline]
• Biological family history of suicidal behavior on the Family History Screen (FHS) [Срок оценки: Baseline]
• Motivation to change sleep-related behavior on the Sleep Motivation Question at Baseline [Срок оценки: Baseline]
• Change from baseline in parent-child conflict on the Conflict Behavior Questionnaire (CBQ) at 2 months and 4 months [Срок оценки: Baseline, 2-months & 4-months]
• Client's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8) [Срок оценки: 4-months]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Nationwide Children's Hospital — Columbus

Публикации

• 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. PMID 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. PMID 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/ PMID 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. PMID 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. PMID 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. PMID 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. PMID 16816228

Идентификаторы

NCT: NCT05390918 · STUDY00002083 · 0920-1301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗