Recruiting

TelehealthPromoting the Well Being of Caregivers Via Telehealth

Sponsor:

Purdue University

Code:

NCT05999448

Conditions

Caregivers

Parents

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

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

Study Details

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.

Conditions

Caregivers

Parents

Study ID

NCT05999448

Start date

Jun 28, 2023

Status verified date

Aug, 2023

Completion date

Dec 29, 2025

Anticipated

Primary completion date

Sep 8, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: No Algorithm + Participation Enhancement Intervention

Participants are randomly assigned to support program without use of a personalized health algorithm AND receive the participation enhancement intervention.

experimental: No Algorithm + No Participation Enhancement Intervention

Participants are randomly assigned to support program without use of a personalized health algorithm AND do not receive the participation enhancement intervention.

experimental: Algorithm 1 + Participation Enhancement Intervention

Participants are assigned to support programs using Algorithm 1 AND receive the participation enhancement intervention.

experimental: Algorithm 1 + No Participation Enhancement Intervention

Participants are assigned to support programs using Algorithm 1 AND do not receive the participation enhancement intervention.

experimental: Algorithm 2 + Participation Enhancement Intervention

Participants are assigned to support programs using Algorithm 2 AND receive the participation enhancement intervention.

experimental: Algorithm 2 + No Participation Enhancement Intervention

Participants are assigned to support programs using Algorithm 2 AND do not receive the participation enhancement intervention.

experimental: Algorithm 3 + Participation Enhancement Intervention

Participants are assigned to support programs using Algorithm 3 AND receive the participation enhancement intervention.

experimental: Algorithm 3 + No Participation Enhancement Intervention

Participants are assigned to support programs using Algorithm 3 AND do not receive the participation enhancement intervention.

no intervention: Waitlist Control

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.

Interventions

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.

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) ]
Change from Baseline on PSOC Total Score at End-of-Treatment Survey [ Time Frame: Baseline and End-of-Treatment (Treatment Week 12) ]
Change from Baseline on PSI-4-SF Total Score at End-of-Treatment Survey [ Time Frame: Baseline and End-of-Treatment (Treatment Week 12) ]
Change in Average PANAS Negative Affect between Baseline and End-of-Treatment [ Time Frame: Baseline and End-of-Treatment (Treatment Week 12) ]
Change in Average Momentary Stress between Baseline and End-of-Treatment [ Time Frame: Baseline and End-of-Treatment (Treatment Week 12) ]
Change from Baseline on CGI-S at End-of-Treatment [ Time Frame: Baseline and End-of-Treatment (Treatment Week 12) ]
Clinical Global Impression-Improvement (CGI-I) at End-of-Treatment [ Time Frame: End-of-Treatment (single administration at Treatment Week 12) ]
Peer Coach Fidelity Across Treatment Sessions [ Time Frame: Calculated at End-of-Treatment (Treatment Week 12) ]
Coaching Session Completion [ Time Frame: Calculated at End-of-Treatment (Treatment Week 12) ]
Treatment Session Completion [ Time Frame: Calculated at End-of-Treatment (Treatment Week 12) ]
Peer Coaching Satisfaction [ Time Frame: End-of-Treatment (single administration at Treatment Week 12) ]
Treatment Satisfaction [ Time Frame: End-of-Treatment (single administration at Treatment Week 12) ]
Drop Out Status [ Time Frame: Calculated at End-of-Treatment (Treatment Week 12) ]
Homework Completion [ Time Frame: Calculated at End-of-Treatment (Treatment Week 12) ]

Central Contacts and Locations

Central contacts

Bridgette L Kelleher, PhD

18438100238 bkelleher@purdue.edu

Locations

Purdue University

Recruiting

West Lafayette, Indiana, United States, 47907

Contacts

Veronika Vozka, MS

765-494-6754 wellcast@purdue.edu

Principal Investigator:

Bridgette Kelleher, PhD

More Information

Sponsor

Purdue University

Last update posted

Aug 21, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Purdue University on 2023-08-21.