# 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.
**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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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:
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.*
*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.
*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.
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?
| | Inclusion criteria | Exclusion criteria |
| --- | --- | --- |
| Population | KQ 1. Children and adolescents aged 3 to 18 years
known anxiety and/or depression | Studies with ≥20% of participants in the following groups and do not report findings by population. |
| Interventions | KQ 1-3 | Pharmacologic interventions or traditional psychotherapies alone (
cognitive-behavioral therapy, play therapy, dialectical behavior therapy, parent-child interaction therapy) and integrative therapies alone including acupuncture/acupressure, expressive therapies, exercise, yoga, Tai Chi, biofeedback, hypnotherapy, massage, chiropractic care, homeopathy, diets (
gluten-free diet), traditional Chinese medicine, and Ayurveda. |
| Comparators | KQ 1. Usual care, enhanced usual care, waitlist control, sham, attention control, or no active intervention | Other interventions not listed in the “included” list. |
| Outcomes | KQ 1-3 | Other outcomes, parent/caregiver outcomes. |
| | • Quality of life (
PedsQL, KIDSCREEN, CHQ, ITQOL, PQ-LES-Q) | |
| | • General and social functioning (
SDQ, SSIS, CGI-I, CGAS), including behavior problems (
ECBI, CBCL, SDQ), coping skills (
CSI-CA, CCSC, RSQ), executive functioning (
BRIEF), academic performance (
WIAT, Woodcock-Johnson Tests of Achievement) | |
| | • Disability (
VABS, FDI, days of missed school) | |
| | • Depression (
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 (
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 (
CAMM) | |
| | • Autonomic arousal (
SCL, HRV) | |
| | • Executive functioning (
BRIEF) | |
| | • Subjective well-being (
PANAS-C, SLSS) | |
| | • Substance use | |
| | • Psychological flexibility (
AFQ-Y, AAQ) | |
| | • Healthcare utilization | |
| Timing | • A minimum of 4 weeks since the beginning of the intervention or baseline assessment (if the intervention start cannot be determined) for all outcomes except for harms | Mid-intervention assessment times. |
| | • 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 subacute settings (
partial hospitalization programs, intensive outpatient 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 controlled trials (individually or site-randomized), with individually randomized trials reporting outcomes for a minimum of 10 participants per treatment arm | Other study designs. |
| | • Period 1 data from crossover RCTs | |
| | • Published in English-language | |
| | • Published in 2010 or later | |
Dated: June 27, 2024.
Marquita Cullom,
Associate Director.