Promoting the Well Being of Caregivers Via Telehealth

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

Interventions

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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)

BEHAVIORAL

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.

Sponsors & Collaborators

• University of Virginia

  collaborator OTHER

• University of Oregon

  collaborator OTHER

• University of Canterbury

  collaborator OTHER

• University of Missouri-Columbia

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Georgia State University

  collaborator OTHER

• Purdue University

  lead OTHER

Principal Investigators

• Bridgette Kelleher, PhD · Purdue University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-28

Primary Completion

2025-09-08

Completion

2025-12-29

Countries

• United States

Study Locations