Promoting the Well Being of Caregivers Via Telehealth
WellCAST
Optimizing a Personalized Health Approach for Virtually Treating High-risk Caregivers During COVID-19 and Beyond
1 other identifier
interventional
800
1 country
1
Brief Summary
The goal of this clinical trial is to learn which types of telehealth-based treatments best fit the needs of caregivers of people with rare neurogenetic conditions. The main questions it plans to answer are:
- Which telehealth support programs best meet the needs of rare disorder caregivers?
- How can individuals be matched to support programs that are right for them? What aspects of an individual (e.g., demographics, mental health symptoms, family characteristics, lifestyle) predict whether treatment will be a good fit?
- Does peer-to-peer coaching help improve patients' experiences during telehealth treatment? Participants will be asked to complete a 12-week treatment program, which may include self-guided resources, individual therapies, group therapies, and/or peer-to-peer coaching. Before, during, and after treatment, participants will complete questionnaires to help researchers understand their experiences, symptoms, and impressions of their support program. Questionnaires will include both standard forms (administered up to 5 times throughout the study) and brief "snapshot surveys" that participants complete on their smartphones up to 3 times per day. Some participants will be assigned to a waitlist control, which means that they will provide data while they are not yet completing a support program. These participants will be assigned to a support program in the next treatment phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
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 Start
First participant enrolled
June 28, 2023
CompletedFirst Submitted
Initial submission to the registry
July 17, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2025
CompletedAugust 21, 2023
August 1, 2023
2.2 years
July 17, 2023
August 11, 2023
Conditions
Outcome Measures
Primary Outcomes (14)
Change from Baseline on DASS-21 Total-Score at End-of-Treatment Survey
The patient-reported Depression, Anxiety, and Stress Scale, 21 Total Score ranges from 0-63; higher scores indicate greater impairment. Change is measured as (Week 12-Baseline), statistically controlling for Baseline levels.
Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on PSOC Total Score at End-of-Treatment Survey
The patient-reported Parenting Sense of Competence Total Score includes ranges from 17-102; higher scores indicate greater parenting sense of competency. Wording was adapted from the original 1978 measure to be inclusive of caregivers who are not biological parents or mothers. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on PSI-4-SF Total Score at End-of-Treatment Survey
The patient-reported Parenting Stress Index, 4th Edition (PSI-4-SF) Total T-Score ranges from 0-100; higher scores indicate greater stress. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.
Baseline and End-of-Treatment (Treatment Week 12)
Change in Average PANAS Negative Affect between Baseline and End-of-Treatment
The patient-reported Positive and Negative Affect Scale (10 items) Negative Affect subscale total score ranges from 10-50; higher scores indicate greater negative affect. For each evaluation period, scores will be averaged across week-long patient-reported ecological momentary assessments, which are collected 3 times per day and 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
Baseline and End-of-Treatment (Treatment Week 12)
Change in Average Momentary Stress between Baseline and End-of-Treatment
The patient-reported momentary stress item ranges from 0-100; higher scores indicate greater stress. For each evaluation period, scores will be averaged across week-long patient-reported ecological momentary assessments, which are collected 3 times per day and 7 days per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on CGI-S at End-of-Treatment
The Clinical Global Impression-Severity (CGI-S) is rated by the patient's primary clinician on a scale of 1-7, with higher scores indicating greater impairment. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
Baseline and End-of-Treatment (Treatment Week 12)
Clinical Global Impression-Improvement (CGI-I) at End-of-Treatment
The Clinical Global Impression-Improvement (CGI-S) is rated by the patient's primary clinician on a scale of 1-7, with higher scores indicating greater impairment. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.
End-of-Treatment (single administration at Treatment Week 12)
Peer Coach Fidelity Across Treatment Sessions
Fidelity will be observer-rated by reliable coders to generate a fidelity ratio (0-100%), defined as the proportion of pre-defined critical session components administered to "acceptable" criterion; higher ratios indicate greater fidelity. The total fidelity score for each patient is calculated as the average of completed Baseline, Midpoint, and End-of-Treatment sessions.
Calculated at End-of-Treatment (Treatment Week 12)
Coaching Session Completion
Completion will be reported by project staff and used to generate a completion ratio (0-100%), defined as the proportion of sessions attended; higher ratios indicate greater completion.
Calculated at End-of-Treatment (Treatment Week 12)
Treatment Session Completion
Completion will be reported by clinicians to generate a completion ratio (0-100%), defined as the proportion of sessions attended; higher ratios indicate greater completion. Participants in the self-guided resource condition will self-report completion across 12 weeks of tasks using a log submitted at end of treatment.
Calculated at End-of-Treatment (Treatment Week 12)
Peer Coaching Satisfaction
Patient-reported peer coaching satisfaction scores are averaged across a study-specific feedback survey and range from 1-5; higher scores indicate greater satisfaction.
End-of-Treatment (single administration at Treatment Week 12)
Treatment Satisfaction
Patient-reported treatment satisfaction scores are averaged across a study-specific feedback survey and range from 1-5; higher scores indicate greater satisfaction.
End-of-Treatment (single administration at Treatment Week 12)
Drop Out Status
"Drop out" is defined as discontinuation of treatment after consenting to treatment and attending at least one session, including active discontinuation and patients lost to follow-up. Variable is dummy coded where 0=patient did not drop out, 1=patient dropped out.
Calculated at End-of-Treatment (Treatment Week 12)
Homework Completion
Completion will be reported by clinicians to generate a completion ratio (0-100%), defined as the proportion of assigned session homework completed; higher ratios indicate greater completion. Participants in the self-guided resource condition will self-report completion across 12 weeks of tasks using a log submitted at end of treatment.
Calculated at End-of-Treatment (Treatment Week 12)
Secondary Outcomes (10)
Change from Baseline on EES-2 Total Score at End-of-Treatment Survey
Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on DERS Total Score at End-of-Treatment Survey
Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on CBCL Total Problem Behaviors at End-of-Treatment Survey
Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on CDI-Words and Gestures at End-of-Treatment Survey
Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on CSHQ at End-of-Treatment Survey
Baseline and End-of-Treatment (Treatment Week 12)
- +5 more secondary outcomes
Other Outcomes (4)
Change in Daily Reports of Health Behaviors between Baseline and End-of-Treatment
Baseline and End-of-Treatment (Treatment Week 12)
Change in Daily Reports of Caregiver Sleep between Baseline and End-of-Treatment
Baseline and End-of-Treatment (Treatment Week 12)
Change in Momentary Self-Efficacy between Baseline and End-of-Treatment
Baseline and End-of-Treatment (Treatment Week 12)
- +1 more other outcomes
Study Arms (9)
No Algorithm + Participation Enhancement Intervention
EXPERIMENTALParticipants are randomly assigned to support program without use of a personalized health algorithm AND receive the participation enhancement intervention.
No Algorithm + No Participation Enhancement Intervention
EXPERIMENTALParticipants are randomly assigned to support program without use of a personalized health algorithm AND do not receive the participation enhancement intervention.
Algorithm 1 + Participation Enhancement Intervention
EXPERIMENTALParticipants are assigned to support programs using Algorithm 1 AND receive the participation enhancement intervention.
Algorithm 1 + No Participation Enhancement Intervention
EXPERIMENTALParticipants are assigned to support programs using Algorithm 1 AND do not receive the participation enhancement intervention.
Algorithm 2 + Participation Enhancement Intervention
EXPERIMENTALParticipants are assigned to support programs using Algorithm 2 AND receive the participation enhancement intervention.
Algorithm 2 + No Participation Enhancement Intervention
EXPERIMENTALParticipants are assigned to support programs using Algorithm 2 AND do not receive the participation enhancement intervention.
Algorithm 3 + Participation Enhancement Intervention
EXPERIMENTALParticipants are assigned to support programs using Algorithm 3 AND receive the participation enhancement intervention.
Algorithm 3 + No Participation Enhancement Intervention
EXPERIMENTALParticipants are assigned to support programs using Algorithm 3 AND do not receive the participation enhancement intervention.
Waitlist Control
NO INTERVENTIONParticipants are enrolled in the waitlist control condition, which includes identical data collection procedures to participants enrolled in support programs. Waitlist controls are offered the opportunity to enroll in future cycles.
Interventions
ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.
RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)
A standardized PEI intervention will be conducted by trained peer coaches who are also rare disorder caregivers. Each peer coach will work with their clients to complete a "Change Plan Worksheet" and will complete two booster sessions at midpoint and end of treatment. Coaches will also meet with their clients after follow-up data are complete to support connection back to community resources and patient-specific rare disorder communities.
Eligibility Criteria
You may qualify if:
- Caregiver and legal guardian of child age 2-35 with neurogenetic condition
- Child's syndrome must (1) have an established genetic cause, (2) affect the brain, resulting in moderate to severe intellectual disability in the majority of patients
- Reside in US
- Fluent in English (spoken and written)
- Seeking support for caregiver mental health/well-being and/or caregiving needs
You may not qualify if:
- Serious mental illness or active addiction that would be inadequately addressed through dosage of treatments
- Actively in treatment that would be redundant with those offered in the protocol
- Child's syndrome is not commonly associated with (1) life expectancy less than 35 years or (2) deterioration of previously gained skills.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Universitylead
- University of Virginiacollaborator
- University of Oregoncollaborator
- University of Canterburycollaborator
- University of Missouri-Columbiacollaborator
- Indiana Universitycollaborator
- Georgia State Universitycollaborator
Study Sites (1)
Purdue University
West Lafayette, Indiana, 47907, United States
Related Publications (3)
Kelleher BL. CASCADE: a community-engaged action model for generating rapid, patient-engaged decisions in clinical research. BMC Med Res Methodol. 2025 Jul 1;25(1):168. doi: 10.1186/s12874-025-02565-7.
PMID: 40597746DERIVEDKelleher B, Emerson K, Graham LN, Vozka V, Wheeler A, Fadel W, Foti D, Metzger I, Rispoli M, Machalicek W, McLay L, Lane S, Neo WS, Carter A, Brown L, Brown J, McIntyre LL, Salwitz E, Dietz G, Naughton R, Peek K, Hollins N, Woodford E. Optimizing a Personalized Health Approach for Virtually Treating High-Risk Caregivers of Children With Neurogenetic Conditions (Project WellCAST): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 25;14:e64360. doi: 10.2196/64360.
PMID: 40560646DERIVEDKelleher BL. CASCADE: A Community-Engaged Action Model for Generating Rapid, Patient-Engaged Decisions in Clinical Research. Res Sq [Preprint]. 2024 Aug 27:rs.3.rs-4790564. doi: 10.21203/rs.3.rs-4790564/v1.
PMID: 39257986DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bridgette Kelleher, PhD
Purdue University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Care providers will be masked to the status of peer coaching and algorithm assignment. Peer coaches will be masked to the status of algorithm assignment. Data managers and statisticians evaluating study outcomes will be provided de-identified data and will not be involved in treatment-related study operations.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 17, 2023
First Posted
August 21, 2023
Study Start
June 28, 2023
Primary Completion
September 8, 2025
Study Completion
December 29, 2025
Last Updated
August 21, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Primary outcome IPD will be shared no later than 12 months after study completion.
- Access Criteria
- Data access may be requested for eligible studies and qualified researchers for the purpose of addressing specific scientific objectives. A mutually signed Data Use Agreement (non-negotiable contract for data use and sharing) must be in place before accessing requested information. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with only information necessary to address the research objectives under the terms of the data sharing agreement.
IPD will be shared with other researchers using best-practices in open science.