Notice2024-14573
Supplemental Evidence and Data Request on Mindfulness-Based Interventions for Mental Health and Wellbeing in Children and Adolescents: A Systematic Review
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Published
July 2, 2024
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 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 89 Issue 127 (Tuesday, July 2, 2024)</title>
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[Federal Register Volume 89, Number 127 (Tuesday, July 2, 2024)]
[Notices]
[Pages 54822-54824]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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published and unpublished pertinent scientific information will improve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: <a href="/cdn-cgi/l/email-protection#ee8b9e8dae8f869c9fc086869dc0898198"><span class="__cf_email__" data-cfemail="8feaffeccfeee7fdfea1e7e7fca1e8e0f9">[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 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Kelly Carper, telephone: 301-427-1656
or email: <a href="/cdn-cgi/l/email-protection#385d485b7859504a491650504b165f574e"><span class="__cf_email__" data-cfemail="3451445774555c46451a5c5c471a535b42">[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 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: <a href="https://effectivehealthcare.ahrq.gov/products/ped-mindfulness/protocol">https://effectivehealthcare.ahrq.gov/products/ped-mindfulness/protocol</a>
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 <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, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://effectivehealthcare.ahrq.gov/email-updates">https://effectivehealthcare.ahrq.gov/email-updates</a>.
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 <bullet> 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 <bullet> 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 <bullet> With major
both. behavioral or
emotional
dysregulation
(e.g., conduct
disorder,
oppositional
defiant disorder,
disruptive mood
dysregulation
disorder).\a\
<bullet> 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.,
<bullet> Mindfulness- cognitive-
based intervention, behavioral therapy,
provided alone or play therapy,
in addition to dialectical
other therapies. behavior therapy,
<bullet> 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
<bullet> 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.
<bullet> 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:.
<bullet> Mindfulness-
based Stress
Reduction.
<bullet> Mindfulness-
based Cognitive
Therapy.
<bullet> Acceptance
and Commitment
Therapy.
Components of
programs, if they
are intentionally
used to promote
mindfulness
principles and meet
other criteria, may
include:.
<bullet> Relaxation
techniques.
<bullet> Meditation.
<bullet> Mindful
breathing.
<bullet> Guided
imagery.
<bullet>
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).
<bullet> Quality of
life (e.g., PedsQL,
KIDSCREEN, CHQ,
ITQOL, PQ-LES-Q).
<bullet> 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).
<bullet> Disability
(e.g., VABS, FDI,
days of missed
school).
<bullet> 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).
<bullet> 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).
<bullet> Any
reported adverse
events or
unintended negative
consequences
attributed to
treatment.
Additional outcomes
(children and
adolescents
outcomes).
<bullet> Acceptance
of experiences in
the present moment
(e.g., CAMM).
<bullet> Autonomic
arousal (e.g., SCL,
HRV).
<bullet> Executive
functioning (e.g.,
BRIEF).
<bullet> Subjective
well-being (e.g.,
PANAS-C, SLSS).
<bullet> Substance
use.
[[Page 54824]]
<bullet>
Psychological
flexibility (e.g.,
AFQ-Y, AAQ).
<bullet> Healthcare
utilization.
Timing...................... <bullet> 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.
<bullet> 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,
<bullet> and psychiatric
Administered in subacute settings
outpatient health (e.g., partial
care or community hospitalization
settings (e.g., programs, intensive
schools, outpatient
residential). programs).
<bullet> Trials
conducted in
countries rated as
``very high'' on
the 2019 Human
Development Index
(as defined by the
United Nations
Development
Program).
Study Design................ <bullet> 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.
<bullet> Period 1
data from crossover
RCTs.
<bullet> Published
in English-language.
<bullet> 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
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