NCT07375043

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Mar 2026Jun 2026

First Submitted

Initial submission to the registry

January 14, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

January 14, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

autismstressparentscaregiversanxietydepression

Outcome Measures

Primary Outcomes (3)

  • K-10

    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

    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

    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.

Study Arms (1)

Intervention

EXPERIMENTAL

Parents will participate in drumming sessions that teach stress management techniques, sense of belonging, and coping skills for depression and anxiety.

Behavioral: Group Drumming

Interventions

Group DrummingBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gateway Building, Room 361 & 363, Arizona State University

Tempe, Arizona, 85287, United States

Location

MeSH Terms

Conditions

DepressionAutistic DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAutism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Eugenia Hernandez Ruiz, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Music Therapy

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 29, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Researchers will make the data available upon written request

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
January 2027 -December 2031
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.
More information

Locations