NCT07360600

Brief Summary

The goal of this clinical trial is to evaluate the feasibility, usability, and preliminary benefits of implementing ACT Together for parents of children with disabilities in pediatric outpatient clinics. ACT Together includes six self-paced, web-based modules and brief weekly one-on-one coaching sessions led by a trained occupational therapist. The program is based on acceptance and commitment therapy (ACT), which teaches practical skills to help people handle stress and difficult thoughts or feelings while taking steps toward what matters to them. The main questions this study aims to answer are:

  • Can parents and occupational therapists complete the study activities as planned (e.g., module completion, coaching sessions, and surveys)?
  • Is the program usable and acceptable/appropriate/feasible to implement in this setting?
  • Do parents show improvements in mental health and coping-related outcomes after participating in the program?
  • What are the experiences and perspectives of parents and therapists regarding the program? Parents as participants will:
  • Complete six self-paced web-based modules and brief weekly individual phone coaching sessions with a trained occupational therapist working in pediatric outpatient clinics.
  • Complete online questionnaires before starting and after completing the program.
  • Take part in one online interview about their experiences and perspectives on the program. Occupational therapists as participants will:
  • Complete therapist training materials and deliver brief individual phone coaching sessions to parent participants, including completing a post-session checklist.
  • Complete brief online questionnaires before starting and after delivering the program.
  • Take part in one online interview about their experiences and perspectives on the program.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Mar 2026Nov 2026

First Submitted

Initial submission to the registry

January 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 18, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

January 13, 2026

Last Update Submit

May 9, 2026

Conditions

Keywords

Acceptance and Commitment Therapyweb-based interventioninternet-based interventionoccupational therapistparentschildren with disabilitiesdepressive symptomsstressfeasibilityacceptabilityusabilityimplementationmixed methodsPilot Studyphone coaching

Outcome Measures

Primary Outcomes (4)

  • Enrollment rate

    The enrollment rate will be calculated as the number of participants who consent and complete the baseline evaluation divided by the number of participants who are eligible and invited to participate in the study.

    During the recruitment period (up to approximately 6 months)

  • Retention

    Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment.

    Baseline through post-intervention (approximately 7-8 weeks)

  • Web-based module completion

    Web-based module completion will be defined as the number of web-based modules completed (range 0-6 modules).

    Baseline through post-intervention (approximately 7-8 weeks)

  • Coaching session completion

    Coaching session completion will be defined as the number of coaching sessions completed (range 0-6 sessions).

    Baseline through post-intervention (approximately 7-8 weeks)

Secondary Outcomes (12)

  • Usability

    Post-intervention (approximately 7-8 weeks)

  • Acceptability of the program

    Post-intervention (approximately 7-8 weeks)

  • Appropriateness of the program

    Post-intervention (approximately 7-8 weeks)

  • Feasibility of the program

    Post-intervention (approximately 7-8 weeks).

  • Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention

    Baseline to post-intervention (approximately 7-8 weeks)

  • +7 more secondary outcomes

Other Outcomes (3)

  • User experiences

    Post-intervention (approximately 7-8 weeks)

  • Coaching session fidelity

    Immediately after each coaching session, throughout the intervention period (approximately weeks 1-6) per parent participant

  • Participant Perceptions of Online Modules, Phone Coaching Sessions, and Training Materials

    Post-intervention (approximately 7-8 weeks)

Study Arms (1)

Acceptance and commitment therapy (ACT) group

EXPERIMENTAL

The ACT group will complete the ACT Together program.

Behavioral: ACT Together

Interventions

ACT TogetherBEHAVIORAL

ACT Together includes six self-paced, weekly web-based ACT modules and six brief phone coaching sessions delivered after each module by a trained occupational therapist.

Acceptance and commitment therapy (ACT) group

Eligibility Criteria

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

You may qualify if:

  • Community-dwelling adults (aged ≥18 years) with primary caregiving responsibility for a child with disabilities (aged \<18 years) who is enrolled in a participating clinic;
  • Expected to use services at the participating clinic at least once per week over the next three months;
  • Willing to learn strategies to cope with emotions and thoughts; and
  • Have access to a web-enabled device (e.g., smartphone, tablet, laptop, or desktop) with reliable internet access at home or in a public space (e.g., library).

You may not qualify if:

  • Cognitive, physical, sensory impairments, or language barriers (non-English speaking) that would impede participation;
  • Suicidal intent or suicide attempt(s) within the past six months;
  • Participation in another parent support research study at the time of recruitment; or
  • More than three hospitalizations of either the parent or child within the past year, or other serious health concerns that would interfere with program engagement.
  • Have three or more years of clinical experience in a pediatric setting and be willing to participate in training, program implementation, and study evaluations; and
  • Currently work in a clinic that serves at least 15 children who attend the clinic at least once per week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Areum Han, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Areum Han, PhD

CONTACT

Jeremy Jenkins, MS

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 22, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations