Promoting the Well Being of Caregivers Via Telehealth

Parents Clinical Trial

— WellCAST  

Official title:

Optimizing a Personalized Health Approach for Virtually Treating High-risk Caregivers During COVID-19 and Beyond

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05999448
• Other study ID #: R01HD105502
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: December 29, 2025

Study information

• Verified date: August 2023
• Source: Purdue University
• Contact: Bridgette L Kelleher, PhD
• Phone: 18438100238
• Email: bkelleher[@]purdue.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Project WellCAST (Supporting Wellbeing of Caregivers via Telehealth) is a multi-phase research study that aims to develop a scalable, personalized health approach for supporting caregivers of people with rare disorders. Two previous studies by this research team have piloted individual interventions in subsets of rare disorder caregiving communities to establish initial feasibility and acceptability. Now in its third phase, Project WellCAST 3.0 aims to generate a scalable, innovative model for personalizing digital treatments to caregiver needs. This project has two specific aims:

AIM 1: Develop and optimize a personalized health algorithm to match neurogenetic syndrome (NGC) caregivers to digital health treatments using a combination of standard clinical tools and smartphone-based EMA data.

Extant clinical and EMA data on NGC caregiver response to COVID-19 was used to develop an initial routing algorithm to match families to treatment type and intensity. This aim will compare the effectiveness of algorithm-assigned treatment to "treatment as usual," optimizing the algorithm across four waves of intervention. Interventions will be brief, evidence-based, digital health treatments administered by highly supervised clinical trainees, a cost-efficient model for directly targeting the secondary health effects of COVID-19.

AIM 2: Test the efficacy of peer-to-peer coaching, deployed by trained NGC caregivers using an evidence-based motivational interviewing protocol, in enhancing treatment uptake and clinical outcomes.

Peer coaches who are also NGC caregivers will be trained to deploy evidence-based Participation Enhancement Interventions designed to support treatment engagement and reduce potential barriers. This aim will evaluate the feasibility and effectiveness of this approach in reducing secondary health effects of COVID-19 by comparing outcomes across participants who were randomized to complete treatment with and without peer coaches. Peer coaches will also provide valuable stakeholder input for designing and optimizing the digital treatment network.

DETAILED HUMAN SUBJECTS PROCEDURE:

ENROLLMENT AND CONSENT 1. At the entry of the study, caregivers will be assessed by the study team to determine eligibility. The caregivers will then consent to baseline collection. A subset of caregivers will be enrolled at this phase as waitlist controls. Waitlist controls will complete the same data collection described below, but without any support program.

BASELINE. The baseline period of the study lasts two weeks. During this time, caregivers will complete initial study forms and "snapshot surveys," which are brief questionnaires sent three times per day via their smartphones.

ROUTING. After baseline data collection is complete, caregivers will be routed to a support program. Random number generators will be used to route caregivers to their study arm, described below.

Caregivers may opt out of broadly completing either child-focused or self-focused treatments but may not select their specific treatment modality. As an exception, any Black caregiver in the study is eligible to add the CICBT group to their assigned support program.

CONSENT 2 and INTERVENTION. Participants will provide informed consent specific to their assigned intervention then begin their 12-week support program. Programs are described below. During intervention, caregivers will be asked to complete study forms to assess how their characteristics and experiences have changed interventions; forms will be collected at start of treatment, midpoint, and endpoint. Caregivers will also complete "snapshot surveys" (3x/day) during this time.

FOLLOW UP. Two weeks after completing treatment, caregivers will complete follow-up forms and a 2-week period of "snapshot surveys."

ADDITIONAL PROCEDURES:

This study will occur across four phases. Phases I and II will enroll up to 500 participants (to yield 400 participants total) who will be randomly assigned to Algorithm (Algorithm 1 versus No Algorithm) and Peer Coaching (Peer Coaching versus No Peer Coaching).

After Phase II, investigators will convene a "think tank" that will evaluate primary and secondary endpoints across arms, with the goal of determining how to optimize the algorithm. Data analyses will be performed by staff who are not involved in clinical operations. Peer coaches (who are rare disorder caregivers), clinicians, biostatisticians, and scientists will collaboratively participate in this think tank, with the goal to optimize the algorithm prior to Phase III.

Phase III will enroll up to 250 participants (to yield 200) who will receive the optimized Algorithm 2 and be randomly assigned to Peer Coaching conditions. After Phase III, a second think tank will be convened to optimize Algorithm 3.

Phase IV will enroll up to 250 participants (to yield 200) who will receive the optimized Algorithm 3 and will be randomly assigned to Peer Coaching conditions.

Final analyses will compare Algorithm 3 to Algorithm 2, Algorithm 1, and Waitlist Controls.

RIGOR AND REPRODUCIBILITY.

Algorithms will be uploaded to a secure, locked site prior to each round of study assignment. Analyses will be preregistered, and all code will be available for replication efforts. Masking procedures are described elsewhere in this document.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 29, 2025
• Est. primary completion date: September 8, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Additional treatment-specific inclusion criteria are embedded in the experimental algorithm that will be adjusted through Aim 1.

Related Conditions & MeSH terms

• Caregivers
• Parents

Intervention

Behavioral:
• Acceptance and Commitment Therapy (ACT)
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.
• Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
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.
• Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
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.
• Dialectical Behavioral Therapy (DBT)
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
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 Intervention
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.
• Naturalistic Communication Intervention (NCI)
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.
• Self-Guided Resources
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)
• Participation Enhancement Intervention (PEI)
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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (7)

Lead Sponsor	Collaborator
Purdue University	Georgia State University, Indiana University, University of Canterbury, University of Missouri-Columbia, University of Oregon, University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Daily Reports of Health Behaviors between Baseline and End-of-Treatment	Patients report daily on prior day exercise and substance use; these values will be averaged to yield total scores between 0-100%; higher scores indicate greater proportion of days engaged in exercise and substance use, respectively. For each evaluation period, scores will be averaged across week-long data collection period; these items are collected one time per day, 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)
Other	Change in Daily Reports of Caregiver Sleep between Baseline and End-of-Treatment	Patients report daily on prior day sleep quality (0-100) and duration (0-24 hours); higher scores indicate greater sleep quality and duration, respectively. These items are collected one time per day, 7 days per week, and will be averaged to create one value per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.	Baseline and End-of-Treatment (Treatment Week 12)
Other	Change in Momentary Self-Efficacy between Baseline and End-of-Treatment	The patient-reported momentary competency item is a single rating from 0-100, and higher scores indicate greater perceptions that a person can handle their day. 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)
Other	Change in Daily Reports of Child Challenging Behaviors between Baseline and End-of-Treatment	The patient-reported challenging behavior items monitor (1) severity (scale 0-100) and (2) frequency (0-4 on Likert scale), where higher scores indicate more challenging behaviors. These items are collected one time per day, 7 days per week, and will be averaged to create one value per week. Change will be measured as (Week 12-Baseline), statistically controlling for Baseline levels.	Baseline and End-of-Treatment (Treatment Week 12)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Change from Baseline on EES-2 Total Score at End-of-Treatment Survey	The patient-reported Emotion Efficacy Scale-2 (Revised) generates a Total Score from 10-50; higher scores indicate greater emotion efficacy. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.	Baseline and End-of-Treatment (Treatment Week 12)
Secondary	Change from Baseline on DERS Total Score at End-of-Treatment Survey	The patient-reported Difficulties in Emotion Regulation Scale (DERS) Total Score includes possible scores that range from 36-180; higher scores indicate greater difficulties in emotion regulation. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.	Baseline and End-of-Treatment (Treatment Week 12)
Secondary	Change from Baseline on CBCL Total Problem Behaviors at End-of-Treatment Survey	The patient-rated Child Behavior Checklist (CBCL 1.5-5), which the patient uses to describe their child's behaviors, yields a Total Problem Behaviors T-Score that ranges from 50-100; higher scores indicate greater child challenging behavior. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.	Baseline and End-of-Treatment (Treatment Week 12)
Secondary	Change from Baseline on CDI-Words and Gestures at End-of-Treatment Survey	The patient-rated Communicative Development Inventory, Words and Gestures Edition (Vocabulary Checklist: Level I), which the patient uses to describe their child's language, yields a yields a total raw score ranging from 0-89; higher scores indicate greater communicative development. Primary outcome will be "understanding" subscale total score. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.	Baseline and End-of-Treatment (Treatment Week 12)
Secondary	Change from Baseline on CSHQ at End-of-Treatment Survey	The patient-rated Children's Sleep Habits Questionnaire, which the patient uses to describe their child's behaviors, yields a total raw score ranging from 33-99; higher scores indicate greater sleep challenges. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.	Baseline and End-of-Treatment (Treatment Week 12)
Secondary	Change from Baseline on Albany Sleep Problems scale at End-of-Treatment Survey	The patient-rated Albany Sleep Problems scale, which the patient uses to describe their child's behaviors, yields a total raw score ranging from 0-164; higher scores indicate greater sleep challenges. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.	Baseline and End-of-Treatment (Treatment Week 12)
Secondary	Change from Baseline on ZBI-7 at End-of-Treatment Survey	The patient-reported Zarit Burden Inventory Short Form (7 item version) generates a Total Score that ranges from 0-49; higher scores indicate greater burden. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.	Baseline and End-of-Treatment (Treatment Week 12)
Secondary	Change from Baseline on ABC-2 at End-of-Treatment Survey	The patient-rated Aberrant Behavior Checklist - 2nd edition, which the patient uses to describe their child's behaviors, yields a total raw score that ranges from 0-174; higher scores indicate greater child challenging behavior. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.	Baseline and End-of-Treatment (Treatment Week 12)
Secondary	Change from Baseline on MIBI at End-of-Treatment Survey	The patient-reported Multidimensional Inventory of Black Identity (MIBI) generates a Total Score that ranges from 0-49; higher scores indicate greater burden. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.	Baseline and End-of-Treatment (Treatment Week 12)
Secondary	Change from Baseline on PCL-5 at End-of-Treatment Survey	The patient-reported PTSD Checklist for DSM-5 (PCL-5) generates a Total Score that ranges from 0-80; higher scores indicate greater burden. Change is measured as (Week 12-Baseline), statistically controlling for Baseline symptoms.	Baseline and End-of-Treatment (Treatment Week 12)