[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44981-44983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11197]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Management of Suicidal 
Thoughts and Behaviors in Youth

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submission.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Management of 
Suicidal Thoughts and Behaviors in Youth, which is currently being 
conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. 
Access to published and unpublished pertinent scientific information 
will improve the quality of this review.

DATES: Submission Deadline on or before June 21, 2024.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:

Mailing Address: Center for Evidence and Practice Improvement, Agency 
for Healthcare Research and Quality, Attn: EPC SEADs Coordinator, 5600 
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice 
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC 
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 
20857

FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656 
or email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Management of Suicidal 
Thoughts and Behaviors in Youth. AHRQ is conducting this review 
pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 
299a.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Management of Suicidal Thoughts and Behaviors in Youth. 
The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/suicidal-thoughts-youth/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Management of Suicidal Thoughts and Behaviors 
in Youth helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this topic. In the list, please indicate whether results 
are available on ClinicalTrials.gov along with the ClinicalTrials.gov 
trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements, if 
relevant: study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this topic. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including, if relevant, a study number, the 
study period, design, methodology, indication and diagnosis, proper use 
instructions, inclusion and exclusion criteria, and primary and 
secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this topic and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on topics not included 
in the review cannot be used by the EPC Program. This is a voluntary 
request for information, and all costs for complying with this request 
must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.
    The review will answer the following questions. This information is 
provided as background. AHRQ is not requesting that the public provide 
answers to these questions.

Key Questions (KQ)

    KQ 1. For youth, what are the effectiveness, comparative 
effectiveness, and harms of treatments for suicidal thoughts and 
behaviors?
    (a) What are the components of effective psychosocial treatments 
(e.g., frequency or intensity of therapy and/or aspects of the 
therapeutic modality)?
    (b) How do social determinants of health, racism and disparities, 
care

[[Page 44982]]

delivery methods, patient demographics and psychiatric or developmental 
co-occurring conditions affect outcomes?

 PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
                                Setting)
------------------------------------------------------------------------
       PICOTS elements         Inclusion criteria    Exclusion criteria
------------------------------------------------------------------------
Population..................   Ages 5-24       Animals.
                               years who have a      Adults aged
                               heightened risk for   >25 years.
                               suicide, including--
 
                              [cir] Those who have
                               suicidal ideation
                               (i.e., thinking
                               about or planning
                               suicide) with or
                               without self-
                               injurious behaviors
                               (i.e., suicide
                               attempt or self-
                               injurious behavior,
                               including self-
                               directed deliberate
                               injury or potential
                               for injury).
                              [cir] Those who have
                               made suicide
                               attempts in the
                               absence of known
                               suicidal ideation.
                              [cir] Those who have
                               a recent hospital
                               discharge for
                               mental health
                               treatment.
                              [cir] Those who have
                               shown command
                               hallucination
                               (i.e., auditory
                               hallucinations that
                               instruct a patient
                               to act in specific
                               manners) or intense
                               stress/distress.
                              [cir] Those who are
                               identified as
                               having heightened
                               risk by PHQ-9, C-
                               SSRS, or ASQ.
                              [cir] Those who are
                               from racial/ethnic
                               minority groups
                               known to have
                               increased risk of
                               suicide.
                              [cir] Those who are
                               from the LGBTQ+
                               community.
                              [cir] Those who have/
                               had exposure to
                               high crime/violence.
Interventions...............   An             
                               intervention aimed   Complementary or
                               to reduce suicidal   integrative health
                               and thoughts         interventions (e.g.,
                               behaviors--          light therapy,
                              [cir] Psychosocial    supplements).
                               interventions.
                              [cir]
                               Pharmacological
                               therapy.
                              [cir]
                               Neurotherapeutics
                               and emerging
                               therapies.
                              [cir] Combination
                               therapies of the
                               above.
Comparators.................     Treatment     None.
                              as usual
                               Another
                               psychosocial
                               intervention.
                               Another
                               pharmacological
                               therapy.
                               Combination
                               therapies of the
                               above.
Outcomes....................     Suicidal      None.
                              behaviors (e.g.,
                              suicidal attempts,
                              self-harm with
                              suicidal intent,
                              self-harm without
                              suicidal intent)
                               Suicidal
                               ideation.
                               Measures of
                               severity of suicide
                               ideation and intent
                               (e.g., C-SSRS,
                               Sheehan STS, SIQ).
                               Deaths by
                               suicide.
                              
                               Hospitalizations
                               for suicidal
                               thoughts or
                               behaviors.
                               Emergency
                               department visits
                               for suicidal
                               thoughts or
                               behaviors.
                               Measures of
                               psychological
                               functioning after
                               receiving an
                               intervention
                               targeting suicidal
                               behaviors and
                               thoughts (e.g.,
                               depression,
                               anxiety, stress,
                               coping, sense of
                               purpose, agency,
                               burdensomeness,
                               thwarted belonging
                               as reported by
                               child and
                               caregivers, quality
                               of life.
                               School
                               outcomes [e.g.,
                               functioning in
                               school, attendance,
                               drop-out]).
                               Adverse
                               events, including
                               study withdrawals.
Timing......................     At the        None.
                              end of intervention
                              and at the end of
                              followup
Settings....................     Any           None.
                              (e.g., outpatient,
                              inpatient, emergency
                              department)
Study design................     RCTs          In vitro
                               Comparative  studies.
                               observational         Nonoriginal
                               studies.              studies (e.g.,
                               Before--      narrative reviews,
                               after studies.        editorials,
                               Relevant      letters, or
                               systematic reviews,   erratum).
                               or meta-analyses      Cross-
                               (used for             sectional (i.e.,
                               identifying           nonlongitudinal)
                               additional studies).  studies.
Subgroup analysis...........     Delivery    None.
                              methods (e.g.,
                              telehealth, in-home
                              treatment, school-
                              based intervention,
                              clinic)
                               Age group
                               (5-13 years, 14-17
                               years, and 18-24
                               years).
                               Gender/
                               gender identity.
                               Race/
                               ethnicity.
                               History of
                               trauma.
                               Experience
                               of racial/ethnic
                               discrimination and
                               marginalization.
                               Sexual
                               orientation.
                               Co-
                               occurring
                               conditions (e.g.,
                               MDD, bipolar
                               disorder, mood
                               disorders,
                               substance use
                               disorders, eating
                               disorders,
                               posttraumatic
                               stress disorder,
                               autism,
                               intellectual/
                               developmental
                               disabilities, other
                               special needs),.
                              
                               Intervention
                               objectives (i.e.,
                               addressing suicidal
                               thoughts vs.
                               suicidal behaviors;
                               ongoing treatments
                               following crisis
                               care vs. crisis
                               care).
                               Clinical
                               settings (e.g.,
                               outpatient,
                               inpatient,
                               residential,
                               emergency
                               department).
                               Timing of
                               outcome assessment
                               (e.g., long-term
                               outcome assessment,
                               short-term outcome
                               assessment).
                               Social
                               determinants of
                               health (e.g.,
                               access to mental
                               healthcare, access
                               to housing,
                               poverty, exposure
                               to violence/crime).

[[Page 44983]]

 
Publications................     Full-text     Non-
                              peer-reviewed         English language
                              studies published in  studies.
                              English                Conference
                               Studies       abstracts.
                               published after the
                               year 2000.
------------------------------------------------------------------------
Abbreviations: ASQ = Ask Suicide-Screening Questions; C-SSRS = Columbia
  Suicide Severity Rating Scale; LGBTQ+ = Lesbian Gay Bisexual
  Transgender Queer/Questioning Plus/Others; MDD = major depressive
  disorder; PHQ-9 = Patient Health Questionnaire-9; RCT = randomized
  controlled trial; Sheehan STS = Sheehan Suicidality Tracking Scale;
  SIQ = Suicidal Ideation Questionnaire.


    Dated: May 16, 2024.
Mamatha Pancholi,
Deputy Director.
[FR Doc. 2024-11197 Filed 5-21-24; 8:45 am]
BILLING CODE 4160-90-P