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

Mass General Brigham

Status: Completed

Conditions: Parenting; Attention Difficulties; Learning Disabilities, Child; Stress

Treatments: Behavioral: SMART-3RP; Behavioral: Health Education Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06492278

1R56AT011869-01A1 (U.S. NIH Grant/Contract)

2024P001219

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

SMART-3RP

Experimental group

Description:

This is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD.

Treatment:

Behavioral: SMART-3RP

Health Education Program

Active Comparator group

Description:

This is an adapted 8-session group program to provide health behavior education.

Treatment:

Behavioral: Health Education Program