Notice2023-07129
Supplemental Evidence and Data Request on Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents
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Published
April 6, 2023
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 88 Issue 66 (Thursday, April 6, 2023)</title>
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[Federal Register Volume 88, Number 66 (Thursday, April 6, 2023)]
[Notices]
[Pages 20522-20524]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-07129]
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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.
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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unpublished pertinent scientific information will improve the quality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: <a href="/cdn-cgi/l/email-protection#7f1a0f1c3f1e170d0e5117170c51181009"><span class="__cf_email__" data-cfemail="0267726142636a70732c6a6a712c656d74">[email protected]</span></a>.
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: <a href="/cdn-cgi/l/email-protection#94f1e4f7d4f5fce6e5bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="b6d3c6d5f6d7dec4c798dedec598d1d9c0">[email protected]</span></a>.
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: <a href="https://effectivehealthcare.ahrq.gov/products/disruptive-behavior/protocol">https://effectivehealthcare.ahrq.gov/products/disruptive-behavior/protocol</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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
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