CaregiversWellCASTNCT05999448
Promoting the Well Being of Caregivers Via Telehealth
A study testing Acceptance and Commitment Therapy (ACT), Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual and Culturally Informed Cognitive Behavioral Therapy (CICBT), Group in people with Caregivers and Parents, run by Purdue University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregivers, Parents
- What is being tested?
- Acceptance and Commitment Therapy (ACT), Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual and Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2023to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Purdue University
West Lafayette, Indiana, 47907
Veronika Vozka, MS, 765-494-6754, wellcast@purdue.edu
Bridgette Kelleher, PhD
About this study
Official title: Optimizing a Personalized Health Approach for Virtually Treating High-risk Caregivers During COVID-19 and Beyond
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?
Read more
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.
Read the detailed 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.
- Conditions
- Caregivers, Parents
- Being tested
- Acceptance and Commitment Therapy (ACT), Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual, Culturally Informed Cognitive Behavioral Therapy (CICBT), Group, Dialectical Behavioral Therapy (DBT), Durand Sleep Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
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), IndividualBehavioural
Also called Trauma Focused Cognitive Behavioral Therapy
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), GroupBehavioural
Also called Trauma Focused Cognitive Behavioral Therapy
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)Behavioural
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 InterventionBehavioural
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 InterventionBehavioural
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)Behavioural
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 ResourcesBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No Algorithm + Participation Enhancement Intervention | Experimental | Participants are randomly assigned to support program without use of a personalized health algorithm AND receive the participation enhancement intervention. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual; Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group; Behavioral: Dialectical Behavioral Therapy (DBT); Behavioral: Durand Sleep Intervention; Behavioral: RUBI Intervention; Behavioral: Naturalistic Communication Intervention (NCI); Behavioral: Self-Guided Resources; Behavioral: Participation Enhancement Intervention (PEI) |
| No Algorithm + No Participation Enhancement Intervention | Experimental | Participants are randomly assigned to support program without use of a personalized health algorithm AND do not receive the participation enhancement intervention. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual; Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group; Behavioral: Dialectical Behavioral Therapy (DBT); Behavioral: Durand Sleep Intervention; Behavioral: RUBI Intervention; Behavioral: Naturalistic Communication Intervention (NCI); Behavioral: Self-Guided Resources |
| Algorithm 1 + Participation Enhancement Intervention | Experimental | Participants are assigned to support programs using Algorithm 1 AND receive the participation enhancement intervention. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual; Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group; Behavioral: Dialectical Behavioral Therapy (DBT); Behavioral: Durand Sleep Intervention; Behavioral: RUBI Intervention; Behavioral: Naturalistic Communication Intervention (NCI); Behavioral: Self-Guided Resources; Behavioral: Participation Enhancement Intervention (PEI) |
| Algorithm 1 + No Participation Enhancement Intervention | Experimental | Participants are assigned to support programs using Algorithm 1 AND do not receive the participation enhancement intervention. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual; Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group; Behavioral: Dialectical Behavioral Therapy (DBT); Behavioral: Durand Sleep Intervention; Behavioral: RUBI Intervention; Behavioral: Naturalistic Communication Intervention (NCI); Behavioral: Self-Guided Resources |
| Algorithm 2 + Participation Enhancement Intervention | Experimental | Participants are assigned to support programs using Algorithm 2 AND receive the participation enhancement intervention. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual; Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group; Behavioral: Dialectical Behavioral Therapy (DBT); Behavioral: Durand Sleep Intervention; Behavioral: RUBI Intervention; Behavioral: Naturalistic Communication Intervention (NCI); Behavioral: Self-Guided Resources; Behavioral: Participation Enhancement Intervention (PEI) |
| Algorithm 2 + No Participation Enhancement Intervention | Experimental | Participants are assigned to support programs using Algorithm 2 AND do not receive the participation enhancement intervention. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual; Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group; Behavioral: Dialectical Behavioral Therapy (DBT); Behavioral: Durand Sleep Intervention; Behavioral: RUBI Intervention; Behavioral: Naturalistic Communication Intervention (NCI); Behavioral: Self-Guided Resources |
| Algorithm 3 + Participation Enhancement Intervention | Experimental | Participants are assigned to support programs using Algorithm 3 AND receive the participation enhancement intervention. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual; Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group; Behavioral: Dialectical Behavioral Therapy (DBT); Behavioral: Durand Sleep Intervention; Behavioral: RUBI Intervention; Behavioral: Naturalistic Communication Intervention (NCI); Behavioral: Self-Guided Resources; Behavioral: Participation Enhancement Intervention (PEI) |
| Algorithm 3 + No Participation Enhancement Intervention | Experimental | Participants are assigned to support programs using Algorithm 3 AND do not receive the participation enhancement intervention. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual; Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group; Behavioral: Dialectical Behavioral Therapy (DBT); Behavioral: Durand Sleep Intervention; Behavioral: RUBI Intervention; Behavioral: Naturalistic Communication Intervention (NCI); Behavioral: Self-Guided Resources |
| Waitlist Control | No intervention | Participants 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Calculated at End-of-Treatment (Treatment Week 12)
Secondary outcomes (10)
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.
Measured: Baseline and End-of-Treatment (Treatment Week 12)
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.
Measured: Baseline and End-of-Treatment (Treatment Week 12)
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.
Measured: Baseline and End-of-Treatment (Treatment Week 12)
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.
Measured: Baseline and End-of-Treatment (Treatment Week 12)
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.
Measured: Baseline and End-of-Treatment (Treatment Week 12)
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.
Measured: Baseline and End-of-Treatment (Treatment Week 12)
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.
Measured: Baseline and End-of-Treatment (Treatment Week 12)
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.
Measured: Baseline and End-of-Treatment (Treatment Week 12)
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.
Measured: Baseline and End-of-Treatment (Treatment Week 12)
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.
Measured: Baseline and End-of-Treatment (Treatment Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start28 Jun 2023
- Primary completion8 Sep 2025 (estimated)
- Study completion29 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- For Waves I-II, caregivers are randomly assigned to either (1) route to a treatment using their personalized health data ("Algorithm 1") OR route to treatment randomly ("No Algorithm"); for Waves III and IV, caregivers are randomly assigned to Algorithm 1 or an optimized Algorithm 2 (Wave III) or Algorithm 2 or an optimized and final Algorithm 3 (Wave IV). Across Waves I-IV, caregivers are randomly assigned to receive peer coaching ("Peer Coaching") or to receive check-ins by a staff member unfamiliar with the peer coaching protocol ("No Peer Coaching"). Across Waves I-III, a subset of caregivers are assigned to a waitlist control that does not include any treatment or peer coaching.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, University of Oregon, University of Canterbury, University of Missouri-Columbia, Indiana University, Georgia State University
- Responsible party
- Principal investigator, KelleherLab, Purdue University
- Investigators
- Bridgette Kelleher, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999448
- Sponsor's protocol ID
- R01HD105502
- Acronym
- WellCAST
- Status last verified
- Aug 2023
- First submitted
- 17 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with other researchers using best-practices in open science.
Publications
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.
PubMed 40597746Kelleher 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.
PubMed 40560646Kelleher 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.
PubMed 39257986
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Personalized Health Approach for Virtually Treating High-risk Caregivers During COVID-19 and Beyond
- ClinicalTrials.gov ID
- NCT05999448
- Acronym / sponsor ID
- WellCAST / R01HD105502
- Conditions
- Caregivers, Parents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- University of Virginia, University of Oregon, University of Canterbury, University of Missouri-Columbia, Indiana University, Georgia State University
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 8 Sep 2025 (estimated)
- Study completion
- 29 Dec 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 9
- Model description
- For Waves I-II, caregivers are randomly assigned to either (1) route to a treatment using their personalized health data ("Algorithm 1") OR route to treatment randomly ("No Algorithm"); for Waves III and IV, caregivers are randomly assigned to Algorithm 1 or an optimized Algorithm 2 (Wave III) or Algorithm 2 or an optimized and final Algorithm 3 (Wave IV). Across Waves I-IV, caregivers are randomly assigned to receive peer coaching ("Peer Coaching") or to receive check-ins by a staff member unfamiliar with the peer coaching protocol ("No Peer Coaching"). Across Waves I-III, a subset of caregivers are assigned to a waitlist control that does not include any treatment or peer coaching.
| Arm | Type | Receives |
|---|---|---|
| No Algorithm + Participation Enhancement Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual, Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group, Behavioral: Dialectical Behavioral Therapy (DBT), Behavioral: Durand Sleep Intervention, Behavioral: RUBI Intervention, Behavioral: Naturalistic Communication Intervention (NCI), Behavioral: Self-Guided Resources, Behavioral: Participation Enhancement Intervention (PEI)Participants 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 | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual, Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group, Behavioral: Dialectical Behavioral Therapy (DBT), Behavioral: Durand Sleep Intervention, Behavioral: RUBI Intervention, Behavioral: Naturalistic Communication Intervention (NCI), Behavioral: Self-Guided ResourcesParticipants 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 | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual, Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group, Behavioral: Dialectical Behavioral Therapy (DBT), Behavioral: Durand Sleep Intervention, Behavioral: RUBI Intervention, Behavioral: Naturalistic Communication Intervention (NCI), Behavioral: Self-Guided Resources, Behavioral: Participation Enhancement Intervention (PEI)Participants are assigned to support programs using Algorithm 1 AND receive the participation enhancement intervention. |
| Algorithm 1 + No Participation Enhancement Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual, Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group, Behavioral: Dialectical Behavioral Therapy (DBT), Behavioral: Durand Sleep Intervention, Behavioral: RUBI Intervention, Behavioral: Naturalistic Communication Intervention (NCI), Behavioral: Self-Guided ResourcesParticipants are assigned to support programs using Algorithm 1 AND do not receive the participation enhancement intervention. |
| Algorithm 2 + Participation Enhancement Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual, Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group, Behavioral: Dialectical Behavioral Therapy (DBT), Behavioral: Durand Sleep Intervention, Behavioral: RUBI Intervention, Behavioral: Naturalistic Communication Intervention (NCI), Behavioral: Self-Guided Resources, Behavioral: Participation Enhancement Intervention (PEI)Participants are assigned to support programs using Algorithm 2 AND receive the participation enhancement intervention. |
| Algorithm 2 + No Participation Enhancement Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual, Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group, Behavioral: Dialectical Behavioral Therapy (DBT), Behavioral: Durand Sleep Intervention, Behavioral: RUBI Intervention, Behavioral: Naturalistic Communication Intervention (NCI), Behavioral: Self-Guided ResourcesParticipants are assigned to support programs using Algorithm 2 AND do not receive the participation enhancement intervention. |
| Algorithm 3 + Participation Enhancement Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual, Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group, Behavioral: Dialectical Behavioral Therapy (DBT), Behavioral: Durand Sleep Intervention, Behavioral: RUBI Intervention, Behavioral: Naturalistic Communication Intervention (NCI), Behavioral: Self-Guided Resources, Behavioral: Participation Enhancement Intervention (PEI)Participants are assigned to support programs using Algorithm 3 AND receive the participation enhancement intervention. |
| Algorithm 3 + No Participation Enhancement Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual, Behavioral: Culturally Informed Cognitive Behavioral Therapy (CICBT), Group, Behavioral: Dialectical Behavioral Therapy (DBT), Behavioral: Durand Sleep Intervention, Behavioral: RUBI Intervention, Behavioral: Naturalistic Communication Intervention (NCI), Behavioral: Self-Guided ResourcesParticipants are assigned to support programs using Algorithm 3 AND do not receive the participation enhancement intervention. |
| Waitlist Control | No intervention | –Participants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Algorithm 1 + No Participation Enhancement Intervention, Algorithm 1 + Participation Enhancement Intervention, Algorithm 2 + No Participation Enhancement Intervention, Algorithm 2 + Participation Enhancement Intervention, Algorithm 3 + No Participation Enhancement Intervention, Algorithm 3 + Participation Enhancement Intervention, No Algorithm + No Participation Enhancement Intervention, No Algorithm + Participation Enhancement Intervention |
| Culturally Informed Cognitive Behavioral Therapy (CICBT), IndividualAlso: Trauma Focused Cognitive Behavioral TherapyCICBT-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. | Behavioural | Algorithm 1 + No Participation Enhancement Intervention, Algorithm 1 + Participation Enhancement Intervention, Algorithm 2 + No Participation Enhancement Intervention, Algorithm 2 + Participation Enhancement Intervention, Algorithm 3 + No Participation Enhancement Intervention, Algorithm 3 + Participation Enhancement Intervention, No Algorithm + No Participation Enhancement Intervention, No Algorithm + Participation Enhancement Intervention |
| Culturally Informed Cognitive Behavioral Therapy (CICBT), GroupAlso: Trauma Focused Cognitive Behavioral TherapyCICBT-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. | Behavioural | Algorithm 1 + No Participation Enhancement Intervention, Algorithm 1 + Participation Enhancement Intervention, Algorithm 2 + No Participation Enhancement Intervention, Algorithm 2 + Participation Enhancement Intervention, Algorithm 3 + No Participation Enhancement Intervention, Algorithm 3 + Participation Enhancement Intervention, No Algorithm + No Participation Enhancement Intervention, No Algorithm + Participation Enhancement Intervention |
| 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. | Behavioural | Algorithm 1 + No Participation Enhancement Intervention, Algorithm 1 + Participation Enhancement Intervention, Algorithm 2 + No Participation Enhancement Intervention, Algorithm 2 + Participation Enhancement Intervention, Algorithm 3 + No Participation Enhancement Intervention, Algorithm 3 + Participation Enhancement Intervention, No Algorithm + No Participation Enhancement Intervention, No Algorithm + Participation Enhancement Intervention |
| Durand Sleep InterventionDurand 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. | Behavioural | Algorithm 1 + No Participation Enhancement Intervention, Algorithm 1 + Participation Enhancement Intervention, Algorithm 2 + No Participation Enhancement Intervention, Algorithm 2 + Participation Enhancement Intervention, Algorithm 3 + No Participation Enhancement Intervention, Algorithm 3 + Participation Enhancement Intervention, No Algorithm + No Participation Enhancement Intervention, No Algorithm + Participation Enhancement Intervention |
| RUBI InterventionRUBI 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. | Behavioural | Algorithm 1 + No Participation Enhancement Intervention, Algorithm 1 + Participation Enhancement Intervention, Algorithm 2 + No Participation Enhancement Intervention, Algorithm 2 + Participation Enhancement Intervention, Algorithm 3 + No Participation Enhancement Intervention, Algorithm 3 + Participation Enhancement Intervention, No Algorithm + No Participation Enhancement Intervention, No Algorithm + Participation Enhancement Intervention |
| 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. | Behavioural | Algorithm 1 + No Participation Enhancement Intervention, Algorithm 1 + Participation Enhancement Intervention, Algorithm 2 + No Participation Enhancement Intervention, Algorithm 2 + Participation Enhancement Intervention, Algorithm 3 + No Participation Enhancement Intervention, Algorithm 3 + Participation Enhancement Intervention, No Algorithm + No Participation Enhancement Intervention, No Algorithm + Participation Enhancement Intervention |
| Self-Guided ResourcesParticipants 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) | Behavioural | Algorithm 1 + No Participation Enhancement Intervention, Algorithm 1 + Participation Enhancement Intervention, Algorithm 2 + No Participation Enhancement Intervention, Algorithm 2 + Participation Enhancement Intervention, Algorithm 3 + No Participation Enhancement Intervention, Algorithm 3 + Participation Enhancement Intervention, No Algorithm + No Participation Enhancement Intervention, No Algorithm + Participation Enhancement Intervention |
| 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. | Behavioural | Algorithm 1 + Participation Enhancement Intervention, Algorithm 2 + Participation Enhancement Intervention, Algorithm 3 + Participation Enhancement Intervention, No Algorithm + Participation Enhancement Intervention |
Primary outcome
Change from Baseline on DASS-21 Total-Score at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
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.
Change from Baseline on PSOC Total Score at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
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.
Change from Baseline on PSI-4-SF Total Score at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
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.
Change in Average PANAS Negative Affect between Baseline and End-of-Treatment
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
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.
Change in Average Momentary Stress between Baseline and End-of-Treatment
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
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.
Change from Baseline on CGI-S at End-of-Treatment
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
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.
Clinical Global Impression-Improvement (CGI-I) at End-of-Treatment
Time frame: End-of-Treatment (single administration at Treatment Week 12)
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.
Peer Coach Fidelity Across Treatment Sessions
Time frame: Calculated at End-of-Treatment (Treatment Week 12)
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.
Coaching Session Completion
Time frame: Calculated at End-of-Treatment (Treatment Week 12)
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.
Treatment Session Completion
Time frame: Calculated at End-of-Treatment (Treatment Week 12)
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.
Peer Coaching Satisfaction
Time frame: End-of-Treatment (single administration at Treatment Week 12)
Patient-reported peer coaching satisfaction scores are averaged across a study-specific feedback survey and range from 1-5; higher scores indicate greater satisfaction.
Treatment Satisfaction
Time frame: End-of-Treatment (single administration at Treatment Week 12)
Patient-reported treatment satisfaction scores are averaged across a study-specific feedback survey and range from 1-5; higher scores indicate greater satisfaction.
Drop Out Status
Time frame: Calculated at End-of-Treatment (Treatment Week 12)
"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.
Homework Completion
Time frame: Calculated at End-of-Treatment (Treatment Week 12)
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.
10 secondary outcomes
Change from Baseline on EES-2 Total Score at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on DERS Total Score at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on CBCL Total Problem Behaviors at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on CDI-Words and Gestures at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on CSHQ at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on Albany Sleep Problems scale at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on ZBI-7 at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on ABC-2 at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on MIBI at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
Change from Baseline on PCL-5 at End-of-Treatment Survey
Time frame: Baseline and End-of-Treatment (Treatment Week 12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Derived from this study: PubMed 40597746Kelleher 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.
- Derived from this study: PubMed 40560646Kelleher 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.
- Derived from this study: PubMed 39257986Kelleher 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.
- Individual participant dataSharing planned: Yes. IPD will be shared with other researchers using best-practices in open science.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bridgette Kelleher, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT), Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual and Culturally Informed Cognitive Behavioral Therapy (CICBT), Group in people with Caregivers and Parents, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bridgette L Kelleher, PhD (18438100238, bkelleher@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on DASS-21 Total-Score at End-of-Treatment Survey (time frame: Baseline and End-of-Treatment (Treatment Week 12)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05999448, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.