[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]


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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unpublished pertinent scientific information will improve the quality 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: [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