Supplemental Evidence and Data Request on Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents, 20522-20524 [2023-07129]
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Federal Register / Vol. 88, No. 66 / Thursday, April 6, 2023 / Notices
itemizes the goods and services it offers;
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and an Outer Burial Container Price List
at the outset of any discussion of those
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vaults; (3) provide price information
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Affected Public: Private Sector:
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Estimated Number of Annual
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Request for Comment:
On December 19, 2022, the FTC
sought public comment on the
information collection requirements in
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2022). No relevant comments were
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patterns devices, manufacturing
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Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2023–07186 Filed 4–5–23; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Psychosocial and
Pharmacologic Interventions for
Disruptive Behavior in Children and
Adolescents
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Supplemental
Evidence and Data Submissions.
AGENCY:
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
Psychosocial and Pharmacologic
Interventions for Disruptive Behavior in
Children and Adolescents, 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published and unpublished pertinent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 May 8, 2023.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
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 06E53A, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT:
Kelly Carper, Telephone: 301–427–1656
or Email: epc@ahrq.hhs.gov.
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 Psychosocial and
Pharmacologic Interventions for
SUMMARY:
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Disruptive Behavior in Children and
Adolescents. AHRQ is conducting this
systematic 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 Psychosocial and
Pharmacologic Interventions for
Disruptive Behavior in Children and
Adolescents, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/disruptive-behavior/protocol.
This is to notify the public that the
EPC Program would find the following
information on Psychosocial and
Pharmacologic Interventions for
Disruptive Behavior in Children and
Adolescents helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: 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.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication 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
E:\FR\FM\06APN1.SGM
06APN1
Federal Register / Vol. 88, No. 66 / Thursday, April 6, 2023 / Notices
information on indications 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://www.effectivehealthcare.
ahrq.gov/email-updates.
The systematic 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: In children under 18 years of
age diagnosed with disruptive
behaviors, which psychosocial
interventions are more effective for
improving short-term and long-term
psychosocial outcomes compared to no
treatment or other psychosocial
interventions?
KQ 2: In children under 18 years of
age diagnosed with disruptive
behaviors, which pharmacologic
interventions are more effective for
improving short-term and long-term
psychosocial outcomes compared to
placebo or other pharmacologic
interventions?
KQ 3: In children under 18 years of
age diagnosed with disruptive
behaviors, what is the relative
effectiveness of psychosocial
interventions alone compared with
pharmacologic interventions alone for
improving short-term and long-term
psychosocial outcomes?
KQ 4: In children under 18 years of
age diagnosed with disruptive
behaviors, are combined psychosocial
and pharmacologic interventions more
effective for improving short-term and
long-term psychosocial outcomes
compared to either psychosocial or
pharmacologic interventions alone?
KQ 5: What are the harms associated
with treating children under 18 years of
age for disruptive behaviors with either
psychosocial, pharmacologic or
combined interventions?
KQ 6a: Do interventions for disruptive
behaviors vary in effectiveness and
harms based on patient characteristics,
including gender, age (including
pubertal changes and use of oral
contraceptives), racial/ethnic minority,
LGBTQ+ status, English proficiency,
health literacy, socioeconomic status,
insurance status, rural versus urban,
developmental status or delays, family
history of disruptive behavior disorders
or other mental health disorders,
prenatal use of alcohol and drugs
(specifically methamphetamine), history
of trauma or Adverse Childhood
Experiences (ACEs), parental ACEs,
access to social supports (neighborhood
assets, family social support, worship
community, etc.), personal and family
beliefs about mental health (e.g. stigma
around mental health), or other social
determinants of health?
KQ 6b: Do interventions for disruptive
behaviors vary in effectiveness and
harms based on clinical characteristics
or manifestations of the disorder,
including specific disruptive behavior
(e.g., stealing, fighting) or specific
disruptive behavior disorder (e.g.,
20523
oppositional defiant disorder, conduct
disorder), co-occurring behavioral
disorders (e.g., attention deficit
hyperactivity disorder, autism spectrum
disorder, internalizing disorders),
related personality traits and symptom
clusters, presence of non-behavioral
comorbidities, age of onset, and
duration?
KQ 6c: Do interventions for disruptive
behaviors vary in effectiveness and
harms based on treatment history of the
patient?
KQ 6d: Do interventions for disruptive
behaviors vary in effectiveness and
harms based on characteristics of
treatment, including setting (e.g., group
homes, residential treatment, family
setting), duration, delivery, timing, and
dose?
Contextual Question 1. What are the
disparities in the diagnosis of disruptive
behavior disorders (based on
characteristics such as gender, race/
ethnicity, socioeconomic status, other
social determinants of health, or other
factors) in children and adolescents?
Contextual Question 2. What are the
disparities in the treatment of disruptive
behaviors or disruptive behavior
disorders (based on characteristics such
as gender, race/ethnicity, socioeconomic
status, other social determinants of
health, or other factors) in children and
adolescents?
Contextual Question 3. How do
disparities in the diagnosis and
treatment of disruptive behaviors or
disruptive behavior disorders affect
behavioral and functional outcomes
(e.g., compliance with teachers, contact
with the juvenile justice system,
substance abuse)?
POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN (PICOTS)
PICOTS
Inclusion
Exclusion
Population ............
KQs 1–6. Children under 18 years of age who are being treated for disruptive behavior or a disruptive behavior disorder that includes oppositional defiant disorder, conduct disorder, and intermittent explosive disorder; children with a cooccurring diagnosis (e.g., ADHD, ASD) provided the disruptive behavior treated
is due to a DBD will be included.
KQs 1, 3–6. Psychosocial interventions for child, parents/family or both including: ..
—Social skills training.
—Functional behavioral interventions.
—Parent training.
—Psychotherapy (e.g., cognitive behavior therapy, interpersonal psychotherapy, psychodynamic therapy, dialectical behavior therapy, equine-assisted psychotherapy with mental health provider).
—Contingency management methods.
—Behavior management training.
KQs 2–6. Pharmacologic interventions that are FDA approved medications used on
or off label, including the following class of drugs:
—Alpha-agonists.
—Anticonvulsants
—Second-generation (i.e., atypical) antipsychotics.
—Beta-adrenergic blocking agents (i.e., beta-blockers).
—Central nervous system stimulants.
—First-generation antipsychotics.
—Selective serotonin reuptake inhibitors.
—Selective norepinephrine reuptake inhibitors.
—Mood stabilizers.
—Antihistamines.
—Asymptomatic children.
—At-risk children.
—Treatment of disruptive behavior secondary to other
conditions (e.g., substance abuse, developmental delay,
intellectual disability, pediatric bipolar disorder, ADHD).
—Preventive interventions for at-risk populations.
—Preventive interventions for caregiver health.
—Interventions that do not target disruptive behaviors.
—Specialized diet or dietary supplements.
—Speech, occupational, physical therapy.
—Complimentary and Integrative Health interventions
(e.g., acupuncture, herbal remedies).
—Exercise programs as the sole intervention.
—Massage, chiropractic care.
—Invasive medical interventions (e.g., surgery, deep brain
stimulation).
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Interventions .........
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Federal Register / Vol. 88, No. 66 / Thursday, April 6, 2023 / Notices
POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN (PICOTS)—Continued
PICOTS
Inclusion
Comparators .........
Outcomes .............
Timing ...................
Setting ..................
Study Design ........
Exclusion
KQs 4–6. Combined psychosocial and pharmacologic interventions included for
KQs 1–3.
—Other included psychosocial and/or pharmacologic interventions ...........................
—Inactive treatment, including waitlist control, no treatment and placebo.
KQs 1–4, 6. Behavioral outcomes: ..............................................................................
—Aggressive behavior.
—Temper outbursts (not considered age-appropriate).
—Violent behavior.
—Delinquent behavior.
—Fighting, property destruction, and rule violations.
—Compliance with parents, teachers, and institutional rules.
—Affective or mood elements of DBD.
—Treatment satisfaction.
—Other patient-centered outcomes.
KQs 1–4, 6. Functional outcomes:
—Family functioning/cohesion.
—School performance/attendance.
—Interpersonal/social function and competence/need for special accommodations.
—Interactions with legal/juvenile justice systems.
—Out of home placement.
—Health care system utilization.
—Substance abuse.
—Parenting stress.
—Logistical family outcomes (days of work lost, etc.).
—Health-related quality of life (e.g., mental health, physical health).
—Other patient-centered outcomes.
KQ 5. Adverse effects/harms:
—Metabolic effects: weight gain, hyperglycemia and diabetes, hyperlipidemia.
—Extrapyramidal effects: parkinsonism, acute dystonia, akathisia, tardive
dyskinesia.
—Cardiac adverse effects: prolonged QT/arrhythmias, hypotension, cardiomyopathy.
—Prolactin-related effects.
—Neutropenia as a potential adverse effect of atypical antipsychotics.
—Allergic reaction.
—Sleep disruption, fatigue.
—Sudden death.
—Suicide.
—Over-medication or inappropriate medication.
—Negative effects on family dynamics.
—Acne.
—Stigma.
—Harms/barriers to utilization of care related to psychosocial interventions
(e.g., time investment, limited access to trained providers, and lower acceptability based on a misperception that family-focused psychosocial interventions carry implicit judgements about the quality of their parenting).
—Study withdrawal due to medication adverse effects.
KQs 1–6. Any length of follow-up.
KQs 1–6. Clinical setting, including medical or psychosocial care that is delivered
to individuals by clinical professionals (including telehealth), as well as individually focused programs to which clinicians refer their patients; may include classroom settings when intervention is directed to treat disruptive behavior(s) in a
specific child (not the whole class) as part of that child’s treatment plan.
Randomized controlled trials (no sample size limit), comparative nonrandomized
controlled trials that adjust for confounding variables (N≥100), published in
English on or after 1994.
No comparison group, excluded interventions.
Unvalidated outcomes measures.
Exclude school wide or system wide settings (e.g., juvenile justice system) wherein interventions are targeted
more widely.
Published before 1994.
Abbreviations: ADHD=Attention-deficit/hyperactivity disorder; ASD=Autism Spectrum Disorder; DBD=Disruptive Behavior Disorders; FDA=U.S. Food and Drug Administration; KQ=Key Question.
Dated: March 30, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023–07129 Filed 4–5–23; 8:45 am]
ACTION:
Food and Drug Administration
SUMMARY:
BILLING CODE 4160–90–P
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[Docket No. FDA–2022–D–0112]
Considerations for Long-Term Clinical
Neurodevelopmental Safety Studies in
Neonatal Product Development; Draft
Guidance for Industry; Availability;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
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Notice of availability; extension
of comment period.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice announcing the availability of a
draft guidance for industry that
appeared in the Federal Register of
February 13, 2023. In that notice, FDA
requested comments on the draft
guidance for industry entitled
‘‘Considerations for Long-Term Clinical
Neurodevelopmental Safety Studies in
Neonatal Product Development.’’ The
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]]>Agencies
[Federal Register Volume 88, Number 66 (Thursday, April 6, 2023)]
[Notices]
[Pages 20522-20524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07129]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Psychosocial and
Pharmacologic Interventions for Disruptive Behavior in Children and
Adolescents
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Supplemental Evidence and Data Submissions.
-----------------------------------------------------------------------
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 Psychosocial and
Pharmacologic Interventions for Disruptive Behavior in Children and
Adolescents, 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 May 8, 2023.
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 06E53A, 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 Psychosocial and
Pharmacologic Interventions for Disruptive Behavior in Children and
Adolescents. AHRQ is conducting this systematic 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 Psychosocial and Pharmacologic Interventions for
Disruptive Behavior in Children and Adolescents, including those that
describe adverse events. The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/products/disruptive-behavior/protocol.
This is to notify the public that the EPC Program would find the
following information on Psychosocial and Pharmacologic Interventions
for Disruptive Behavior in Children and Adolescents helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. 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: 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 indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including 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 indication 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
[[Page 20523]]
information on indications 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://www.effectivehealthcare.ahrq.gov/email-updates.
The systematic 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: In children under 18 years of age diagnosed with disruptive
behaviors, which psychosocial interventions are more effective for
improving short-term and long-term psychosocial outcomes compared to no
treatment or other psychosocial interventions?
KQ 2: In children under 18 years of age diagnosed with disruptive
behaviors, which pharmacologic interventions are more effective for
improving short-term and long-term psychosocial outcomes compared to
placebo or other pharmacologic interventions?
KQ 3: In children under 18 years of age diagnosed with disruptive
behaviors, what is the relative effectiveness of psychosocial
interventions alone compared with pharmacologic interventions alone for
improving short-term and long-term psychosocial outcomes?
KQ 4: In children under 18 years of age diagnosed with disruptive
behaviors, are combined psychosocial and pharmacologic interventions
more effective for improving short-term and long-term psychosocial
outcomes compared to either psychosocial or pharmacologic interventions
alone?
KQ 5: What are the harms associated with treating children under 18
years of age for disruptive behaviors with either psychosocial,
pharmacologic or combined interventions?
KQ 6a: Do interventions for disruptive behaviors vary in
effectiveness and harms based on patient characteristics, including
gender, age (including pubertal changes and use of oral
contraceptives), racial/ethnic minority, LGBTQ+ status, English
proficiency, health literacy, socioeconomic status, insurance status,
rural versus urban, developmental status or delays, family history of
disruptive behavior disorders or other mental health disorders,
prenatal use of alcohol and drugs (specifically methamphetamine),
history of trauma or Adverse Childhood Experiences (ACEs), parental
ACEs, access to social supports (neighborhood assets, family social
support, worship community, etc.), personal and family beliefs about
mental health (e.g. stigma around mental health), or other social
determinants of health?
KQ 6b: Do interventions for disruptive behaviors vary in
effectiveness and harms based on clinical characteristics or
manifestations of the disorder, including specific disruptive behavior
(e.g., stealing, fighting) or specific disruptive behavior disorder
(e.g., oppositional defiant disorder, conduct disorder), co-occurring
behavioral disorders (e.g., attention deficit hyperactivity disorder,
autism spectrum disorder, internalizing disorders), related personality
traits and symptom clusters, presence of non-behavioral comorbidities,
age of onset, and duration?
KQ 6c: Do interventions for disruptive behaviors vary in
effectiveness and harms based on treatment history of the patient?
KQ 6d: Do interventions for disruptive behaviors vary in
effectiveness and harms based on characteristics of treatment,
including setting (e.g., group homes, residential treatment, family
setting), duration, delivery, timing, and dose?
Contextual Question 1. What are the disparities in the diagnosis of
disruptive behavior disorders (based on characteristics such as gender,
race/ethnicity, socioeconomic status, other social determinants of
health, or other factors) in children and adolescents?
Contextual Question 2. What are the disparities in the treatment of
disruptive behaviors or disruptive behavior disorders (based on
characteristics such as gender, race/ethnicity, socioeconomic status,
other social determinants of health, or other factors) in children and
adolescents?
Contextual Question 3. How do disparities in the diagnosis and
treatment of disruptive behaviors or disruptive behavior disorders
affect behavioral and functional outcomes (e.g., compliance with
teachers, contact with the juvenile justice system, substance abuse)?
Population, Intervention, Comparator, Outcome, Timing, Setting/Study
Design (PICOTS)
------------------------------------------------------------------------
PICOTS Inclusion Exclusion
------------------------------------------------------------------------
Population............... KQs 1-6. Children under --Asymptomatic
18 years of age who are children.
being treated for --At-risk children.
disruptive behavior or --Treatment of
a disruptive behavior disruptive
disorder that includes behavior secondary
oppositional defiant to other
disorder, conduct conditions (e.g.,
disorder, and substance abuse,
intermittent explosive developmental
disorder; children with delay,
a co-occurring intellectual
diagnosis (e.g., ADHD, disability,
ASD) provided the pediatric bipolar
disruptive behavior disorder, ADHD).
treated is due to a DBD
will be included.
Interventions............ KQs 1, 3-6. Psychosocial --Preventive
interventions for interventions for
child, parents/family at-risk
or both including:. populations.
--Social skills --Preventive
training.. interventions for
--Functional behavioral caregiver health.
interventions.. --Interventions
--Parent training....... that do not target
--Psychotherapy (e.g., disruptive
cognitive behavior behaviors.
therapy, interpersonal --Specialized diet
psychotherapy, or dietary
psychodynamic therapy, supplements.
dialectical behavior --Speech,
therapy, equine- occupational,
assisted psychotherapy physical therapy.
with mental health --Complimentary and
provider).. Integrative Health
--Contingency management interventions
methods.. (e.g.,
--Behavior management acupuncture,
training.. herbal remedies).
KQs 2-6. Pharmacologic --Exercise programs
interventions that are as the sole
FDA approved intervention.
medications used on or --Massage,
off label, including chiropractic care.
the following class of --Invasive medical
drugs:. interventions
--Alpha-agonists........ (e.g., surgery,
--Anticonvulsants....... deep brain
--Second-generation stimulation).
(i.e., atypical)
antipsychotics..
--Beta-adrenergic
blocking agents (i.e.,
beta-blockers)..
--Central nervous system
stimulants..
--First-generation
antipsychotics..
--Selective serotonin
reuptake inhibitors..
--Selective
norepinephrine reuptake
inhibitors..
--Mood stabilizers......
--Antihistamines........
[[Page 20524]]
KQs 4-6. Combined
psychosocial and
pharmacologic
interventions included
for KQs 1-3.
Comparators.............. --Other included No comparison
psychosocial and/or group, excluded
pharmacologic interventions.
interventions.
--Inactive treatment,
including waitlist
control, no treatment
and placebo..
Outcomes................. KQs 1-4, 6. Behavioral Unvalidated
outcomes:. outcomes measures.
--Aggressive behavior.
--Temper outbursts (not
considered age-
appropriate).
--Violent behavior.
--Delinquent behavior.
--Fighting, property
destruction, and rule
violations.
--Compliance with
parents, teachers, and
institutional rules.
--Affective or mood
elements of DBD.
--Treatment
satisfaction.
--Other patient-centered
outcomes.
KQs 1-4, 6. Functional
outcomes:
--Family functioning/
cohesion.
--School performance/
attendance.
--Interpersonal/social
function and competence/
need for special
accommodations.
--Interactions with
legal/juvenile justice
systems.
--Out of home placement.
--Health care system
utilization.
--Substance abuse.
--Parenting stress.
--Logistical family
outcomes (days of work
lost, etc.).
--Health-related quality
of life (e.g., mental
health, physical
health).
--Other patient-centered
outcomes.
KQ 5. Adverse effects/
harms:
--Metabolic effects:
weight gain,
hyperglycemia and
diabetes,
hyperlipidemia.
--Extrapyramidal
effects: parkinsonism,
acute dystonia,
akathisia, tardive
dyskinesia.
--Cardiac adverse
effects: prolonged QT/
arrhythmias,
hypotension,
cardiomyopathy.
--Prolactin-related
effects.
--Neutropenia as a
potential adverse
effect of atypical
antipsychotics.
--Allergic reaction.
--Sleep disruption,
fatigue.
--Sudden death.
--Suicide.
--Over-medication or
inappropriate
medication.
--Negative effects on
family dynamics.
--Acne.
--Stigma.
--Harms/barriers to
utilization of care
related to psychosocial
interventions (e.g.,
time investment,
limited access to
trained providers, and
lower acceptability
based on a
misperception that
family-focused
psychosocial
interventions carry
implicit judgements
about the quality of
their parenting).
--Study withdrawal due
to medication adverse
effects.
Timing................... KQs 1-6. Any length of
follow-up.
Setting.................. KQs 1-6. Clinical Exclude school wide
setting, including or system wide
medical or psychosocial settings (e.g.,
care that is delivered juvenile justice
to individuals by system) wherein
clinical professionals interventions are
(including telehealth), targeted more
as well as individually widely.
focused programs to
which clinicians refer
their patients; may
include classroom
settings when
intervention is
directed to treat
disruptive behavior(s)
in a specific child
(not the whole class)
as part of that child's
treatment plan.
Study Design............. Randomized controlled Published before
trials (no sample size 1994.
limit), comparative
nonrandomized
controlled trials that
adjust for confounding
variables (N>=100),
published in English on
or after 1994.
------------------------------------------------------------------------
Abbreviations: ADHD=Attention-deficit/hyperactivity disorder; ASD=Autism
Spectrum Disorder; DBD=Disruptive Behavior Disorders; FDA=U.S. Food
and Drug Administration; KQ=Key Question.
Dated: March 30, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-07129 Filed 4-5-23; 8:45 am]
BILLING CODE 4160-90-P
