Clinical trial NCT06492278: Resiliency Programming for Caregivers of Children with Learning and Attentional Difficulties
Official title: Open Pilot Trial of a Resiliency Group Program for Caregivers of Children with Learning and Attentional Difficulties: Supporting Parents Raising Kids (SPARK)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parenting
Stress
Learning Disabilities, Child
Attention Difficulties
Keywords: Resiliency training
Stress management
Learning and attentional disabilities
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of the refined interventions (SMART-3RP and HEP)
timeFrame: Approximately 3 months (approximately 8-10 weeks after intervention start)
measure: Acceptability of the refined interventions (SMART-3RP and HEP)
timeFrame: Approximately 3 months (approximately 8-10 weeks after intervention start)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elyse R Park, PhD
role: PRINCIPAL_INVESTIGATOR
References: