N/A
N=28
Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties
Parenting · Stress · Learning Disabilities, Child · Attention Difficulties
Bottom Line
View on ClinicalTrials.gov: NCT06492278 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Feasibility of Study Enrollment — 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SMART-3RP (Behavioral); Health Education Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Study Enrollment |
28 | — |
| PRIMARY Feasibility of Intervention Attendance (% Attending at Least 6 of 8 Sessions) |
11; 5 | — |
| PRIMARY Feasibility of Intervention Attendance (% Attending at Least 4 of 8 Sessions) |
12; 9 | — |
| PRIMARY Feasibility of Follow-up Survey Completion |
14; 11 | — |
| PRIMARY Acceptability of the Refined Intervention Content (SMART-3RP and HEP) |
9; 5 | — |
| PRIMARY Acceptability of Number of Sessions |
10; 9 | — |
| PRIMARY Acceptability of Teleconferencing Delivery |
9; 8 | — |
| PRIMARY Acceptability- Group Cohesiveness |
11; 11 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06492278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.