Resiliency Programming for Caregivers of Children with Learning Disabilities

(SPARK Trial)

Overseen By Elyse R Park, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help caregivers of children with learning disabilities (LAD) learn skills to build resilience and manage stress. Participants will join one of two programs: the SMART-3RP, which focuses on mind-body techniques, or a Health Education Program covering topics like sleep, exercise, and nutrition. The trial is open to caregivers who speak English, have internet access, and care for children under 18 with LAD. As an unphased trial, it offers caregivers a unique opportunity to gain valuable skills and support in managing daily challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these programs are safe for caregivers?

Research shows that the SMART-3RP program is safe and easy to manage. Earlier studies adjusted the program for parents of children with learning disabilities, finding it practical and well-liked. Participants reported improvements in self-kindness and anxiety, indicating the program's benefits without harm. Overall, no major negative effects have been linked to the program, making it a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SMART-3RP program because it offers a new way to support parents of children with learning disabilities by focusing on building resilience through relaxation techniques. Unlike typical health education programs that focus on providing information, SMART-3RP integrates the Relaxation Response Resiliency Program (3RP) into an 8-session group setting, which helps caregivers manage stress and improve their mental well-being. This program's emphasis on relaxation and resiliency is particularly promising as it addresses the emotional and psychological needs of caregivers, potentially enhancing their ability to support their children effectively.

What evidence suggests that this trial's programs could be effective for caregivers of children with learning disabilities?

Research has shown that the SMART-3RP program, which stands for Stress Management and Resiliency Training, can help parents of children with learning disabilities by increasing resilience and reducing stress. Studies found that parents in the program felt stronger and exhibited fewer signs of stress, depression, and anxiety. These improvements suggest that SMART-3RP could benefit caregivers by teaching stress management and resilience skills. Initial findings also showed that parents appreciated the program, indicating its potential effectiveness. Overall, the evidence suggests that SMART-3RP is a promising option for caregivers seeking to improve their well-being. Participants in this trial will be randomized to receive either the SMART-3RP program or a Health Education Program, which serves as an active comparator. ^{1 3 4 6 7}

Who Is on the Research Team?

Elyse R Park, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for English-speaking parents or guardians, aged 18 or older, who have a child under 18 with learning and attentional difficulties (LAD) such as dyslexia or ADHD. Participants must be able to join virtual group sessions using internet-connected devices.

Inclusion Criteria

I speak English.

I can join virtual sessions and have a device and internet.

I am the parent or guardian of a child under 18 with LAD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the SMART-3RP or HEP intervention over 8 sessions

8 weeks

8 sessions (in-person or virtual)

Follow-up

Participants complete survey batteries to assess intervention feasibility and acceptability

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health Education Program
• SMART-3RP

Trial Overview The study compares two programs: SMART-3RP, which focuses on mind-body resiliency for caregivers, and the Health Education Program (HEP), which covers sleep, exercise, nutrition, substance use, and healthcare collaboration. Both are adapted from prior research.

How Is the Trial Designed?

Group I: SMART-3RP Experimental Treatment 1 Intervention

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

Group II: Health Education Program Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02772432

Development of a Resiliency Training Program for Parents ... An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities. Intervention/Treatment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8669114/

Acceptability of a Virtual Mind–Body Intervention for ... Results of both trials found that parents in the SMART-3RP demonstrated greater improvements in resiliency, stress reactivity, depression and anxiety symptoms, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949834124000084

Development and feasibility of a virtual, synchronous mind ... A virtual resiliency intervention promoting resiliency for parents of children with learning and attentional disabilities: a randomized pilot trial. Matern ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06492278

Resiliency Programming for Caregivers of Children With ... The primary objective of this protocol is to conduct an open pilot to elicit initial quantitative and qualitative feedback regarding feasibility and ...

5. withpower.com withpower.com/trial/resiliency-programming-for-caregivers-of-children-with-learning-disabilities-93b8c

Resiliency Programming for Caregivers of Children with ... This suggests that the SMART-3RP program, which focuses on resilience, might be effective in supporting caregivers of children with learning disabilities. Show ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23352048/

the Relaxation Response Resiliency Program (3RP) The goal of the 3RP is to enhance individuals' adaptive responses to chronic stress through increasing awareness and decreasing the physiological, emotional, ...

7. ons.org ons.org/publications-research/onf/50/1/outcomes-stress-management-and-resiliency-training-smart-program

Outcomes of a Stress Management and Resiliency ... Data indicate significant improvements in self-compassion (p = 0.03) and anxiety (p = 0.02), with positive trends for resilience, stress, and mindfulness.