Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-18
SponsorJeff Bridge
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
TAILOR
BehavioralThe 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 interventionThe study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary.
Treatment groups
235 Participants
are divided into 2 treatment groupsGroup A: TAILORExperimental treatment 1 intervention
Group B: Enhanced Usual Care (EUC)Other 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline, 2-months & 4-months2
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.
Time frame
Baseline, 2-months & 4-months3
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.
Time frame
Baseline, 2-months & 4-months4
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).
Time frame
Baseline, 2-months & 4-monthsSecondary outcomes
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.
Time frame
Baseline2
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.
Time frame
Baseline3
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.
Time frame
Baseline, 2-months & 4-months4
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.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jeff Bridge
Lead sponsor
Nationwide Children's Hospital
Sponsor institution
Centers for Disease Control and Prevention
Collaborator
Source ClinicalTrials.gov