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Behavioural Intervention

Telehealth Interventions for Caregiver Well-being (WellCAST Trial)

N/A

Recruiting

Led By Bridgette Kelleher, PhD

Research Sponsored by Purdue University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and end-of-treatment (treatment week 12)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to learn which telehealth-based treatments best fit the needs of caregivers of rare neurogenetic conditions by understanding which programs work best and who is best suited to them.

Who is the study for?

This trial is for caregivers and legal guardians of children aged 2-35 with neurogenetic conditions that cause moderate to severe intellectual disability. Participants must live in the US, be fluent in English, and seek support for their mental health or caregiving needs.

What is being tested?

The study tests various telehealth-based treatments like individual/group therapies and peer coaching to see which best supports caregivers of people with rare disorders. It involves a 12-week program with questionnaires before, during, after treatment, plus daily surveys on smartphones.

What are the potential side effects?

Since this trial focuses on psychological support programs rather than medical interventions, traditional side effects are not applicable. However, participants may experience emotional discomfort when discussing personal issues during therapy sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and end-of-treatment (treatment week 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and end-of-treatment (treatment week 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and end-of-treatment (treatment week 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline on CGI-S at End-of-Treatment

Change from Baseline on DASS-21 Total-Score at End-of-Treatment Survey

Change from Baseline on PSI-4-SF Total Score at End-of-Treatment Survey

+11 more

Secondary study objectives

Change from Baseline on ABC-2 at End-of-Treatment Survey

Change from Baseline on Albany Sleep Problems scale at End-of-Treatment Survey

Change from Baseline on CBCL Total Problem Behaviors at End-of-Treatment Survey

+7 more

Other study objectives

Change in Daily Reports of Caregiver Sleep between Baseline and End-of-Treatment

Change in Daily Reports of Child Challenging Behaviors between Baseline and End-of-Treatment

Change in Daily Reports of Health Behaviors between Baseline and End-of-Treatment

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Experimental Treatment

Active Control

Group I: No Algorithm + Participation Enhancement InterventionExperimental Treatment9 Interventions

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

Group II: No Algorithm + No Participation Enhancement InterventionExperimental Treatment8 Interventions

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

Group III: Algorithm 3 + Participation Enhancement InterventionExperimental Treatment9 Interventions

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

Group IV: Algorithm 3 + No Participation Enhancement InterventionExperimental Treatment8 Interventions

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

Group V: Algorithm 2 + Participation Enhancement InterventionExperimental Treatment9 Interventions

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

Group VI: Algorithm 2 + No Participation Enhancement InterventionExperimental Treatment8 Interventions

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

Group VII: Algorithm 1 + Participation Enhancement InterventionExperimental Treatment9 Interventions

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

Group VIII: Algorithm 1 + No Participation Enhancement InterventionExperimental Treatment8 Interventions

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

Group IX: Waitlist ControlActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acceptance and Commitment Therapy (ACT)

2016

Completed Phase 3

~1470

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