Your session is about to expire
← Back to Search
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
WellCAST Trial 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.Check my eligibility
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.See study design
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.
WellCAST Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreOther outcome measures
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 moreWellCAST 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
~1460
Find a Location
Who is running the clinical trial?
University of VirginiaOTHER
754 Previous Clinical Trials
1,244,273 Total Patients Enrolled
University of CanterburyOTHER
3 Previous Clinical Trials
42 Total Patients Enrolled
Purdue UniversityLead Sponsor
224 Previous Clinical Trials
71,964 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am looking for mental health or caregiving support.I am the caregiver and legal guardian of a child aged 2-35 with a neurogenetic condition.My child has a genetic condition affecting the brain, leading to moderate to severe intellectual disability.
Research Study Groups:
This trial has the following groups:- Group 1: Algorithm 1 + No Participation Enhancement Intervention
- Group 2: No Algorithm + No Participation Enhancement Intervention
- Group 3: Algorithm 3 + No Participation Enhancement Intervention
- Group 4: No Algorithm + Participation Enhancement Intervention
- Group 5: Algorithm 1 + Participation Enhancement Intervention
- Group 6: Waitlist Control
- Group 7: Algorithm 2 + No Participation Enhancement Intervention
- Group 8: Algorithm 2 + Participation Enhancement Intervention
- Group 9: Algorithm 3 + Participation Enhancement Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I meet the requirements to participate in this experiment?
"The criteria for entry into this trial is that participants should have a caregiver and be aged between 18 to 70. Up to 800 individuals can apply for the study."
Answered by AI
Does the age restriction for this medical experiment extend to those under 20?
"According to the details of this clinical trial, individuals aged 18 to 70 are eligible for participation. Those younger than 18 or older than 65 have 60 and 88 trials available respectively."
Answered by AI
How many volunteers are engaged in this research endeavor?
"Affirmative. Per the information on clinicaltrials.gov, this trial is actively seeking participants to join. It was first published in late June of 2023 and its most recent update occurred at the start of August that same year. 800 patients must be enrolled from one site."
Answered by AI
Are there any open spots for prospective participants in the current trial?
"Affirmative. As indicated by the clinicaltrials.gov website, this medical investigation is currently recruiting participants. It was first posted on June 28th 2023 and most recently updated August 11th 2023; 800 patients are needed at one test centre."
Answered by AI
What are the aims of this clinical investigation?
"The primary success metric of this trial, measured between the Baseline and End-of-Treatment (Week 12) assessments, is a Change from Baseline in PSOC Total Score. Secondary outcomes include variances in DERS Total Score (which assesses Difficulties in Emotion Regulation), CBCL Total Problem Behaviors T-Score (a Child Behavior Checklist that gauges challenging behavior), and CDI Words & Gestures total raw score (from the Communicative Development Inventory)."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger