Resiliency Programming for Caregivers of Children with Learning and Attentional Difficulties

Not Applicable

Active, not recruiting

• Conditions: Stress; Parenting; Learning Disabilities, Child; Attention Difficulties
• Interventions: Behavioral: SMART-3RP; Behavioral: Health Education Program

• Registration Number: NCT06492278
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

The primary objective of this protocol is to conduct an open pilot to elicit initial quantitative and qualitative feedback regarding feasibility and acceptability of the interventions (SMART-3RP and HEP) that we have refined. Both groups are designed to improve well-being for caregivers experiencing stress-related to caring for a child with LAD.

The investigators will ask participants to complete approximately 15-minute survey batteries via REDCap at baseline and after the 8-week program, including assessments of intervention feasibility and acceptability as well as psychosocial outcomes. To inform plans for ongoing program refinement, the investigators will also elicit specific feedback regarding study assessment tools, recruitment procedures, and group composition.

Results will be used to inform a larger randomized trial.

Study Timeline

• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Study Start: 2024-11-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-03
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMART-3RP	SMART-3RP	This is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD.
Health Education Program	Health Education Program	This is an adapted 8-session group program to provide health behavior education.

Primary Outcome Measures

Name	Time	Method
Feasibility of the refined interventions (SMART-3RP and HEP)	Approximately 3 months (approximately 8-10 weeks after intervention start)	Rates of intervention attendance (# of sessions), rates of participant recruitment (%) enrollment.
Acceptability of the refined interventions (SMART-3RP and HEP)	Approximately 3 months (approximately 8-10 weeks after intervention start)	Likert ratings of group comfort and cohesiveness.

Trial Locations

Locations (1)

MGH; 🇺🇸 Boston, Massachusetts, United States