Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties (NCT06492278) | Clinical Trial Compass
CompletedNot Applicable
Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties
United States28 participantsStarted 2024-11-01
Plain-language summary
This is a randomized open pilot trial enrolling up to 40 co-primary caregivers of children with LAD. Participants will be randomized to receive either mind-body resiliency group (SMART-LAD, intervention) or an evidence-based group intervention Health Education Program (HEP, control) which is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team. Both the SMART-3RP and HEP programs have been modified based on adaptions from our previous qualitative study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* English-speaking
* Age 18 or older
* Ability to participate in group, virtual sessions including access to computer, tablet, or smartphone, and internet
* Parents or guardians of a child (\< age 18) with LAD.
Exclusion Criteria:
* Parents with significant psychiatric conditions (i.e., active suicidality or psychosis) or who are otherwise unable to participate, at the investigators' clinical discretion.
* Only one parent per family can participate.
* Unwilling or unable to participate in the study
* Considered medically or otherwise unable to participate by the study PI
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Study Enrollment
Timeframe: Baseline
2
Feasibility of Intervention Attendance (% Attending at Least 6 of 8 Sessions)
Timeframe: Approximately 3 months (approximately 8-10 weeks after intervention start)
3
Feasibility of Intervention Attendance (% Attending at Least 4 of 8 Sessions)
Timeframe: Approximately 3 months (approximately 8-10 weeks after intervention start)
4
Feasibility of Follow-up Survey Completion
Timeframe: Approximately 3 months (8-10 weeks) post-enrollment
5
Acceptability of the Refined Intervention Content (SMART-3RP and HEP)
Timeframe: Approximately 3 months (approximately 8-10 weeks after intervention start)
6
Acceptability of Number of Sessions
Timeframe: Approximately 3 months (8-10 weeks) post-enrollment