Drumming Groups for Parents of Autistic Children (DG_PAC)

April 27, 2026 updated by: Eugenia Hernandez-Ruiz, Arizona State University
This project aims to encourage a sense of belonging, community, and emotional support for parents of autistic children through a group drumming (music therapy) intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This pilot one-group pretest-posttest study will investigate the limited efficacy and acceptability of an 8-week drumming group on immediate stress (pre-post session) as measured by the STAI-S Short Form scale (Spielberger, 1977); on anxiety and depressive symptoms, as measured by the K-10 scale (Kessler et al., 2002) before and after the 8-week program, and group cohesion and acceptability as measured by the Group Therapy Experience Scale (GTES, Marziliano et al., 2018) after the program. As a group setting, this program does not substitute clinical treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85287
        • Gateway Building, Room 361 & 363, Arizona State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • parents or main caregivers of children in the Autism Spectrum,
  • able to read and write in English.
  • 18 years or older

Exclusion Criteria:

  • Paid caregivers
  • Unable to speak, read and write in English
  • Unable to follow instructions in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Parents will participate in drumming sessions that teach stress management techniques, sense of belonging, and coping skills for depression and anxiety.
Behavioral: Group Drumming
This Drumming program is based on HealthRhythms®, a drumming protocol that has been used extensively in clinical and community populations and has research support (e.g., Grab et al., 2023; Stevens & Fowl, 2024; Wachi et al., 2007). Adaptations will be derived from the PI's clinical and research experience with parents of autistic children. Each drumming session will have the following structure: introduction to the program, light movement & music, icebreakers with small percussions, technique pointers for percussion instruments, rhythmic introductions (sharing names with a percussive rhythm), free group drumming, soundscapes (creating visualizations with drumming), verbal processing, closing drumming exercise. The soundscapes are creative outlets to "paint a picture" with music. These exercises promote community, engagement, emotional expression, and creative thinking, which reduce stress. Specific strategies will include reflecting, mirroring, validating, and solution reframing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
K-10
Time Frame: Pretest at the beginning of the first weekly session, and posttest at the end of the 8th weekly session.
Anxiety and depressive symptoms, as measured by the K-10 scale (Kessler et al., 2002). Maximum score is 50, with each of the 10 items scored 1 to 5. Higher scores indicate higher distress. Optimal cutoff scores for clinically significant nonspecific psychological distress and need for treatment: total score =12, Depression = 7, and Anxiety = 3/4 (Lace et al., 2019).
Pretest at the beginning of the first weekly session, and posttest at the end of the 8th weekly session.
STAI-S
Time Frame: Pretest at the beginning of the first weekly session, and posttest at the end of the 8th weekly session.
Measures of state anxiety as measured by the State Trait Anxiety Inventory for Adults- Short Form Y1 (STAIAD-S Y1) scale (Spielberger, 1977). Maximum score is 40, with each of the 10 items scored 1 to 4, and four reverse-coded items. Higher scores indicate less anxiety (more wellbeing).
Pretest at the beginning of the first weekly session, and posttest at the end of the 8th weekly session.
GTES
Time Frame: Posttest at the end of the 8th weekly session.
Group cohesion and acceptability as measured by the Group Therapy Experience Scale (GTES, Marziliano et al., 2018). Maximum score is 80 with each of the 16 items scored from 1 to 5. Higher scores indicate better group experience.
Posttest at the end of the 8th weekly session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arizona State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eugenia Hernandez Ruiz, PhD, Arizona State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00022914 (OHSU Knight Cancer Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Researchers will make the data available upon written request

IPD Sharing Time Frame

January 2027 -December 2031

IPD Sharing Access Criteria

Investigators with a minimum of a PhD education and institutional affiliation may request aggregated, anonymized data. Raw, anonymized data would be available to researchers in reputable research organizations if an approved study protocol for secondary data analysis is shared with the PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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