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| ID | Type | Description | Link |
|---|---|---|---|
| AOTFIR24Han | Other Grant/Funding Number | American Occupational Therapy Foundation |
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| Name | Class |
|---|---|
| American Occupational Therapy Foundation | OTHER |
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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:
Parents as participants will:
Occupational therapists as participants will:
Parents of children with disabilities often experience elevated psychological distress and may face barriers to accessing timely, evidence-based support. ACT Together is a research-developed program designed to support parents' coping and psychological well-being in a scalable format that can be implemented in pediatric outpatient clinic settings. This study will be a one-group, pretest-posttest mixed-methods pilot to evaluate the feasibility and implementation of ACT Together when delivered as (1) six self-paced, web-based acceptance and commitment therapy (ACT) modules and (2) six brief phone coaching provided by occupational therapists working in pediatric outpatient clinics. All study activities will be coordinated by the University of South Florida (USF) and will be completed remotely using secure online platforms; coaching sessions will be delivered by phone.
Occupational therapists will be recruited via a study flyer and will complete an online screening process. Eligible therapists will complete electronic informed consent and baseline questionnaires and will then access therapist-specific training materials in Canvas. Parents of children with disabilities will be recruited through clinic-based flyer dissemination (e.g., posting or placing flyers at reception). Interested parents will contact the study team and will complete online screening. Eligible parents will complete electronic informed consent and baseline questionnaires and will then receive access to the parent Canvas course.
ACT Together will include six self-paced, weekly web-based ACT modules and six brief coaching sessions (approximately 15-20 minutes each) delivered after each module by a trained occupational therapist. The modules will be hosted on the USF Canvas platform. Two separate Canvas courses will be used: a parent course that includes ACT modules and activities for parents, and a therapist course that includes training materials and structured coaching guidance to support delivery of the brief coaching sessions. Coaching sessions will use structured questions and guidance developed for research purposes and are not intended as standard clinical care. Coaching sessions will be conducted by phone at a mutually agreed time between the parent and the participating occupational therapist. Occupational therapists will complete a brief session checklist in Qualtrics after each coaching session to document that required components were delivered; these checklists will be used to calculate session-level coaching fidelity.
Parents will be encouraged to complete approximately one module per week and to participate in a coaching session after each module over approximately 7-8 weeks. Both parents and occupational therapists will complete questionnaires at pretest and posttest. Parent-reported outcomes will include depressive symptoms, anxiety, perceived stress, psychological quality of life, and ACT-related processes (psychological inflexibility, cognitive fusion, and values-based engagement). Posttest implementation measures will capture perceived usability, acceptability, appropriateness, and feasibility (reported separately by parents and therapists).
Both groups will complete a one-time individual interview at posttest to understand user experiences and implementation perspectives and to inform refinement of the program and study procedures. Post-program interviews will be conducted via the HIPAA-compliant version of Microsoft Teams and will be audio recorded. Interviews are expected to last approximately 40 minutes.
The Canvas course will capture program engagement metrics (e.g., logins, time spent, and module completion) and responses to in-program activities for research purposes. Occupational therapist checklists completed after each coaching session will provide implementation documentation and fidelity indicators. Feasibility indicators will include enrollment rate, retention, and adherence (completion of modules and coaching sessions).
All data will be collected electronically using university-approved secure platforms (Qualtrics, the ACT Together program hosted on USF Canvas, and HIPAA-compliant Microsoft Teams). ACT Together will not be publicly available and will be accessible only to enrolled participants using study-specific login credentials. Identifying information will be collected only as needed for study operations (e.g., communication and compensation) and will be stored separately from research data. Study data will be stored in secure, access-controlled USF systems (including USF Box), with access restricted to authorized study personnel. Only de-identified, aggregate results will be used for dissemination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and commitment therapy (ACT) group | Experimental | The ACT group will complete the ACT Together program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT Together | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Post-intervention (approximately 7-8 weeks) |
| Acceptability of the program |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Post-intervention (approximately 7-8 weeks) |
Inclusion Criteria (Parents of children with disabilities):
Exclusion Criteria (Parents of children with disabilities):
Inclusion Criteria (Occupational therapists):
Exclusion Criteria (Occupational therapists): N/A
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Areum Han, PhD | Contact | 813-396-0524 | areumhan@usf.edu | |
| Jeremy Jenkins, MS | Contact | 813-396-0524 | jeremyjenkins@usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Areum Han, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
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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.
| Post-intervention (approximately 7-8 weeks) |
| 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. | Post-intervention (approximately 7-8 weeks) |
| 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. | Post-intervention (approximately 7-8 weeks). |
| Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention | PHQ-9 is a nine-item self-report questionnaire assessing depressive symptoms over the past two weeks, rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms. | Baseline to post-intervention (approximately 7-8 weeks) |
| Change in Generalized Anxiety Disorder -7 (GAD-7) scores from baseline to post-intervention | GAD-7 is a seven-item self-report questionnaire assessing anxiety symptoms over the past two weeks, rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores reflecting greater anxiety symptoms. | Baseline to post-intervention (approximately 7-8 weeks) |
| Change in Perceived Stress Scale-10 (PSS-10) scores from baseline to post-intervention | PSS-10 is a 10-item questionnaire assessing perceived stress. Items are rated from 0 to 4. Total scores range from 0 to 40, with higher scores indicating greater perceived stress. | Baseline to post-intervention (approximately 7-8 weeks) |
| Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Psychological Health domain scores from baseline to post-intervention | The WHOQOL-BREF Psychological Health domain includes 6 items rated from 1 to 5. Domain scores will be calculated and reported as transformed scores on a 0-100 scale, with higher scores indicating better psychological quality of life. | Baseline to post-intervention (approximately 7-8 weeks) |
| Change in Brief Experiential Avoidance Questionnaire (BEAQ) scores from baseline to post-intervention | BEAQ is a15-item self-report measure of experiential avoidance on a scale of 1 to 6. Total scores range from 15 to 90, with higher scores indicating greater experiential avoidance. | Baseline to post-intervention (approximately 7-8 weeks) |
| Change in Cognitive Fusion Questionnaire-7 (CFQ-7) scores from baseline to post-intervention | CFQ-7 is a 7-item self-report questionnaire measuring cognitive fusion. Items are rated from 1 to 7. Total scores range from 7 to 49, with higher scores indicating a higher degree of cognitive fusion. | Baseline to post-intervention (approximately 7-8 weeks) |
| Change in Engaged Living Scale-9 (ELS-9) scores from baseline to post-intervention | ELS-9 is a 9-item self-assessment instrument measuring clarity and engagement with personal values. Items are rated from 1 to 5. Total scores range from 9 to 45, with higher scores indicating increased clarity and engagement with personal values. | Baseline to post-intervention (approximately 7-8 weeks) |
| Change in Multidimensional Psychological Flexibility Inventory-24 (MPFI-24) scores from baseline to post-intervention | MPFI-24 is a 24-item self-report measure of multidimensional psychological flexibility and inflexibility processes on a scale of 1 to 6. Higher subscale or composite scores indicate greater psychological flexibility or inflexibility. | Baseline to post-intervention (approximately 7-8 weeks) |
| 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. |
| 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 | 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. | Post-intervention (approximately 7-8 weeks) |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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