- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375043
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
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
10
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Parents will participate in drumming sessions that teach stress management techniques, sense of belonging, and coping skills for depression and anxiety.
|
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
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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
March 31, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
January 14, 2026
First Submitted That Met QC Criteria
January 21, 2026
First Posted (Actual)
January 29, 2026
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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