Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties (SPARK)

Open Pilot Trial of a Resiliency Group Program for Caregivers of Children With Learning and Attentional Difficulties: Supporting Parents Raising Kids (SPARK)

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.

Study Overview

• Status: Completed
• Conditions: Stress; Parenting; Attention Difficulties; Learning Disabilities, Child
• Intervention / Treatment: Behavioral: SMART-3RP; Behavioral: Health Education Program

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • MGH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMART-3RP; This is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD.	Behavioral: SMART-3RP; The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Active Comparator: Health Education Program; This is an adapted 8-session group program to provide health behavior education.	Behavioral: Health Education Program; This is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Study Enrollment	Number of participants enrolled in the study, of those eligible	Baseline
Feasibility of Intervention Attendance (% Attending at Least 6 of 8 Sessions)	Number of participants attending at least 6 of 8 group meetings (of those who attended at least 1 group session)	Approximately 3 months (approximately 8-10 weeks after intervention start)
Feasibility of Intervention Attendance (% Attending at Least 4 of 8 Sessions)	Number of participants attending at least 4 of 8 group meetings	Approximately 3 months (approximately 8-10 weeks after intervention start)
Feasibility of Follow-up Survey Completion	Number of participants providing follow-up surveys after group completion	Approximately 3 months (8-10 weeks) post-enrollment
Acceptability of the Refined Intervention Content (SMART-3RP and HEP)	Number of participants rating satisfaction with intervention content as high (at least 4 on a Likert scale of 1-5), of those who attended at least one program session.	Approximately 3 months (approximately 8-10 weeks after intervention start)
Acceptability of Number of Sessions	Number of participants rating satisfaction with number of sessions as high (at least 4 on a Likert scale of 1-5), of those completing at least one group session.	Approximately 3 months (8-10 weeks) post-enrollment
Acceptability of Teleconferencing Delivery	Number of participants rating satisfaction with teleconferencing as high (at least 4 on a Likert scale of 1-5), of those who completed at least one program session.	Approximately 3 months (8-10 weeks) post-enrollment
Acceptability- Group Cohesiveness	Number of participants rating agreement with within-group trust as high (at least 4 on a Likert scale of 1-5), of those who completed at least one program session.	Approximately 3 months (8-10 weeks) post-enrollment

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Elyse R Park, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): March 17, 2025
• Study Completion (Actual): March 17, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Stress management; Resiliency training; Learning and attentional disabilities
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Learning Disabilities
• Other Study ID Numbers: 2024P001219; 1R56AT011869-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No