[Federal Register Volume 89, Number 127 (Tuesday, July 2, 2024)]
[Notices]
[Pages 54822-54824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Mindfulness-Based 
Interventions for Mental Health and Wellbeing in Children and 
Adolescents: A Systematic Review

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

ACTION: Request for supplemental evidence and data submission.

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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 Mindfulness-
Based Interventions for Mental Health and Wellbeing in Children and 
Adolescents: A Systematic Review, which is currently being conducted by 
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published and unpublished pertinent scientific information will improve 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 August 1, 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 Mindfulness-Based 
Interventions for Mental Health and Wellbeing in Children and 
Adolescents: A Systematic Review. 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 Mindfulness-Based Interventions for Mental Health and 
Wellbeing in Children and Adolescents: A Systematic Review. The entire 
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/ped-mindfulness/protocol
    This is to notify the public that the EPC Program would find the 
following information on Mindfulness-Based Interventions for Mental 
Health and Wellbeing in Children and Adolescents: A Systematic Review 
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, 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, 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. What are the benefits and harms of mindfulness-based 
interventions in the general child and adolescent populations?
KQ 2. What are the benefits and harms of mindfulness-based 
interventions in children and adolescents diagnosed with anxiety and/or 
depression?
KQ 3. What are the benefits and harms of mindfulness-based 
interventions in children and adolescents with a chronic condition who 
are at risk for elevated symptoms of anxiety and/or depression?

[[Page 54823]]



 PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
                                Setting)
------------------------------------------------------------------------
                               Inclusion criteria    Exclusion criteria
------------------------------------------------------------------------
Population..................  KQ 1. Children and    Studies with >=20%
                               adolescents aged 3    of participants in
                               to 18 years without   the following
                               known anxiety and/    groups and do not
                               or depression.        report findings by
                              KQ 2. Children and     population.
                               adolescents aged 3    In
                               to 18 years with a    institutions (e.g.,
                               diagnosis of          psychiatric
                               depression and/or     inpatients, long-
                               anxiety.              term care
                              KQ 3. Children and     facilities).
                               adolescents aged 3    Diagnosed
                               to 18 years with a    with advanced
                               chronic condition     neurodevelopmental
                               who are at risk for   disorders (e.g.,
                               elevated symptoms     severe autism
                               of or being           spectrum disorders
                               diagnosed with        [for example, level
                               anxiety and/or        3 on DSM-5], severe
                               depression.           attention-deficit/
                              Definition of          hyperactivity
                               chronic physical      disorder [e.g.,
                               conditions: Medical   based on DSM-5
                               physical conditions   definition], severe
                               (i.e., conditions     learning disorders
                               that primarily        [e.g., more than 2
                               affect the body's     standard deviations
                               systems and           below the mean in
                               functions) that       one or more areas
                               persist for one       of cognitive
                               year or longer and    processing related
                               require ongoing       to the specific
                               medical attention,    learning
                               limit activities of   disorder]).
                               daily living, or      With major
                               both.                 behavioral or
                                                     emotional
                                                     dysregulation
                                                     (e.g., conduct
                                                     disorder,
                                                     oppositional
                                                     defiant disorder,
                                                     disruptive mood
                                                     dysregulation
                                                     disorder).\a\
                                                     With
                                                     substance use
                                                     disorder.
                                                    We will exclude
                                                     studies with MBIs
                                                     designed and/or
                                                     administered only
                                                     to parents/
                                                     caregivers, as well
                                                     as interventions
                                                     administered by
                                                     parents/caregivers.
                                                    We will exclude
                                                     studies designed to
                                                     treat test or
                                                     sports performance
                                                     anxiety, anxiety
                                                     associated with
                                                     medical/dental
                                                     procedures and with
                                                     interventions for
                                                     specific high-risk
                                                     exposures such as
                                                     for post-sexual
                                                     assault or another
                                                     traumatic event.
Interventions...............  KQ 1-3..............  Pharmacologic
                              In addition to the     interventions or
                               minimum               traditional
                               requirements          psychotherapies
                               identified above:.    alone (e.g.,
                               Mindfulness-  cognitive-
                               based intervention,   behavioral therapy,
                               provided alone or     play therapy,
                               in addition to        dialectical
                               other therapies.      behavior therapy,
                               Mindfulness   parent-child
                               is the primary        interaction
                               component for         therapy) and
                               multicomponent        integrative
                               interventions (as a   therapies alone
                               part of behavioral    including
                               and similar non-      acupuncture/
                               pharmacological       acupressure,
                               strategies),          expressive
                               meaning that the      therapies,
                               intervention must     exercise, yoga, Tai
                               be centered around    Chi, biofeedback,
                               mindfulness (e.g.,    hypnotherapy,
                               the majority of the   massage,
                               sessions or focus     chiropractic care,
                               are mindfulness-      homeopathy, diets
                               based).               (e.g., gluten-free
                               A             diet), traditional
                               mindfulness           Chinese medicine,
                               instructor (e.g.,     and Ayurveda.
                               therapist, teacher)
                               must have some
                               training in
                               providing
                               mindfulness. We do
                               not specify the
                               required minimum
                               training.
                               Clear
                               specification of
                               repeated practice
                               (e.g., more than
                               one session with an
                               instructor, or
                               repeated self-
                               directed exercises
                               after at least one
                               initial session
                               with an instructor).
                              Examples of other
                               therapies include
                               structured
                               mindfulness
                               programs and
                               mindfulness-based
                               therapies such as:.
                               Mindfulness-
                               based Stress
                               Reduction.
                               Mindfulness-
                               based Cognitive
                               Therapy.
                               Acceptance
                               and Commitment
                               Therapy.
                              Components of
                               programs, if they
                               are intentionally
                               used to promote
                               mindfulness
                               principles and meet
                               other criteria, may
                               include:.
                               Relaxation
                               techniques.
                               Meditation.
                               Mindful
                               breathing.
                               Guided
                               imagery.
                              
                               Visualization.
Comparators.................  KQ 1. Usual care,     Other interventions
                               enhanced usual        not listed in the
                               care, waitlist        ``included'' list.
                               control, sham,       Other mindfulness-
                               attention control,    based interventions
                               or no active          (i.e., comparative
                               intervention.         effectiveness of
                              KQ 2-3. Usual care,    MBIs).
                               enhanced usual
                               care, waitlist
                               control, sham,
                               attention control,
                               no active
                               intervention, or
                               conventional
                               therapies (i.e.,
                               pharmacotherapy for
                               anxiety and/or
                               depression [see
                               Table 2],
                               behavioral
                               interventions \b\).
Outcomes....................  KQ 1-3..............  Other outcomes,
                              Primary outcomes       parent/caregiver
                               (children and         outcomes.
                               adolescents
                               outcomes).
                               Quality of
                               life (e.g., PedsQL,
                               KIDSCREEN, CHQ,
                               ITQOL, PQ-LES-Q).
                               General and
                               social functioning
                               (e.g., SDQ, SSIS,
                               CGI-I, CGAS),
                               including behavior
                               problems (e.g.,
                               ECBI, CBCL, SDQ),
                               coping skills
                               (e.g., CSI-CA,
                               CCSC, RSQ),
                               executive
                               functioning (e.g.,
                               BRIEF), academic
                               performance (e.g.,
                               WIAT, Woodcock-
                               Johnson Tests of
                               Achievement).
                               Disability
                               (e.g., VABS, FDI,
                               days of missed
                               school).
                               Depression
                               (e.g., CDI, BDI,
                               MFQ, CES-D, CDRS-R,
                               RADS, PHQ-A, PI-
                               ED), diagnosis (KQs
                               2 and 3 only), and
                               remission and
                               response (KQs 1 and
                               3).
                               Anxiety
                               (e.g., SCARED,
                               MASC, SCAS, CAIS,
                               GAD-7, PHQ-A, PI-
                               ED), diagnosis (KQs
                               2 and 3 only), and
                               remission and
                               response (KQs 1 and
                               3).
                               Any
                               reported adverse
                               events or
                               unintended negative
                               consequences
                               attributed to
                               treatment.
                              Additional outcomes
                               (children and
                               adolescents
                               outcomes).
                               Acceptance
                               of experiences in
                               the present moment
                               (e.g., CAMM).
                               Autonomic
                               arousal (e.g., SCL,
                               HRV).
                               Executive
                               functioning (e.g.,
                               BRIEF).
                               Subjective
                               well-being (e.g.,
                               PANAS-C, SLSS).
                               Substance
                               use.

[[Page 54824]]

 
                              
                               Psychological
                               flexibility (e.g.,
                               AFQ-Y, AAQ).
                               Healthcare
                               utilization.
Timing......................   A minimum    Mid-intervention
                               of 4 weeks since      assessment times.
                               the beginning of
                               the intervention or
                               baseline assessment
                               (if the
                               intervention start
                               cannot be
                               determined) for all
                               outcomes except for
                               harms.
                               We will
                               extract harms
                               reported at any
                               followup,
                               regardless of the
                               duration since the
                               intervention start
                               or baseline
                               assessment.
Setting.....................  KQ 1-3..............  In-patient, ED/EMS,
                                             and psychiatric
                               Administered in       subacute settings
                               outpatient health     (e.g., partial
                               care or community     hospitalization
                               settings (e.g.,       programs, intensive
                               schools,              outpatient
                               residential).         programs).
                               Trials
                               conducted in
                               countries rated as
                               ``very high'' on
                               the 2019 Human
                               Development Index
                               (as defined by the
                               United Nations
                               Development
                               Program).
Study Design................   Randomized   Other study designs.
                               controlled trials
                               (individually or
                               site-randomized),
                               with individually
                               randomized trials
                               reporting outcomes
                               for a minimum of 10
                               participants per
                               treatment arm.
                               Period 1
                               data from crossover
                               RCTs.
                               Published
                               in English-language.
                               Published
                               in 2010 or later.
------------------------------------------------------------------------
Abbreviations: AAQ = Acceptance and Action Questionnaire; AFQ-Y =
  Avoidance and Fusion Questionnaire for Youth; BDI = Beck Depression
  Inventory; BRIEF = Behavior Rating Inventory of Executive Function;
  CAIS = Child Anxiety Impact Scale; CAMM = Child and Adolescent
  Mindfulness Measure; CBCL = Child Behavior Checklist; CCSC =
  Children's Coping Strategies Checklist; CDI = Children's Depression
  Inventory; CDRS-R = Children's Depression Rating Scale-Revised; CES-D
  = Center for Epidemiologic Studies Depression Scale; CGAS = Children's
  Global Assessment Scale; CGI-I = Clinical Global Impression-
  Improvement Scale; CHQ = Child Health Questionnaire; CSI-CA = Coping
  Strategies Inventory for Children and Adolescents; ED/EMS = emergency
  department/emergency medical services; ECBI = Eyberg Child Behavior
  Inventory; FDI = Functional Disability Inventory Child Form; GAD-7 =
  Generalized Anxiety Disorder scale; HRV = heart rate variability;
  ITQOL = Infant/Toddler Quality of Life Questionnaire; KQ = Key
  Question; MASC = Multidimensional Anxiety Scale for Children; MFQ =
  Mood and Feelings Questionnaire; NA = not applicable; PedsQL =
  Pediatric Quality of Life Inventory; PHQ-A = Patient Health
  Questionnaire for Adolescents; PICOTS = population, interventions,
  comparators, outcomes, timing, and setting; PI-ED = Paediatric Index
  of Emotional Distress; PQ-LES-Q = Perceived Quality of Life Scale;
  RADS = Reynolds Adolescent Depression Scale; RSQ = Responses to Stress
  Questionnaire; SCARED = Screen for Child Anxiety Related Emotional
  Disorders; SCAS = Spence Children's Anxiety Scale; SCL = Skin
  Conductance Level; SDQ = Strengths and Difficulties Questionnaire;
  SLSS = Students' Life Satisfaction Scale; SSIS = Social Skills
  Improvement System; PANAS-C = Positive and Negative Affect Schedule
  for Children; SWLS = Satisfaction with Life Scale; VABS = Vineland
  Adaptive Behavior Scales; WIAT = Wechsler Individual Achievement Test;
  WISC = Wechsler Intelligence Scale for Children.
\a\ These are reviewed in other AHRQ systematic reviews.
\b\ We defined behavioral interventions as nonpharmacologic strategies
  intended to enhance outcomes by modifying behavior and/or ways of
  thinking (e.g.,cognitive behavioral therapy, coping skills training,
  behavioral therapy, biofeedback, dialectical behavioral therapy).


    Dated: June 27, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-14573 Filed 7-1-24; 8:45 am]
BILLING CODE 4160-90-P