Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Jeff Bridge
Study ID
NCT05390918
Status
Recruiting
Apply to this trial

Conditions

  • Insomnia
  • Suicidal Ideation
  • Suicide, Attempted

Eligibility Criteria

Sex
ALL
Age
11 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • TAILOR — BEHAVIORAL
    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 — OTHER
    The study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary.

Study Details

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.

Key Dates

Start date
Oct 20, 2022
Status verified
Jan 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
235 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • Other: 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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Elizabeth Cannon, MA, MS
[email protected]
614-355-0578
Kendra Heck, MPH
[email protected]
614-355-3433

Find similar trials in Columbus, OH

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Nationwide Children's Hospital· Columbus, OH

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