About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
ACT Together
BehavioralACT 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Retention
Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment.
Web-based module completion
Web-based module completion will be defined as the number of web-based modules completed (range 0-6 modules).
Coaching session completion
Coaching session completion will be defined as the number of coaching sessions completed (range 0-6 sessions).
Secondary outcomes
Usability
Usability will be assessed using the System Usability Scale (SUS; 10 items rated 1 = strongly disagree to 5 = strongly agree; total score 0-100).
Acceptability of the program
Acceptability of the program will be assessed using the Acceptability of Intervention Measure (AIM). AIM includes 4 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scale scores will be calculated and reported separately for parents and therapists.
Appropriateness of the program
Appropriateness will be assessed using the Intervention Appropriateness Measure (IAM). IAM includes 4 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scale scores will be calculated and reported separately for parents and therapists.
Feasibility of the program
Feasibility of the program will be assessed using the Feasibility of Intervention Measure (FIM). FIM includes 4 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scale scores will be calculated and reported separately for parents and therapists.
Other outcomes
User experiences
Individual interviews (\~40 minutes) will be conducted via videoconference to explore experiences among parents (e.g., perceived impact, usability/access, and suggestions for improvement) and therapists (e.g., training, coaching session delivery, and suggestions for improvement).
Coaching session fidelity
After each coaching session, occupational therapists complete a module-specific fidelity checklist (item rating: 0 = Not completed, 1 = Partially completed, 2 = Completed). For each session, a fidelity percentage will be calculated as: (sum of item scores ÷ maximum possible score for that module) × 100. Higher percentages indicate greater fidelity to the coaching protocol.
Participant Perceptions of Online Modules, Phone Coaching Sessions, and Training Materials
Additional questions about the online modules, phone coaching sessions, and training materials in particular (e.g., design, engagement, information quality, and fit) will be administered using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scale scores will be calculated and reported separately for parents and therapists.
Sponsors and contacts
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University of South Florida
Lead sponsor
American Occupational Therapy Foundation
Collaborator