40 Participants Needed

Resiliency Programming for Caregivers of Children with Learning Disabilities

(SPARK Trial)

ER
Overseen ByElyse R Park, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment SMART-3RP for caregivers of children with learning disabilities?

Research shows that interventions aimed at building resilience and self-efficacy (belief in one's ability to succeed) can help parents of children with disabilities manage stress better. This suggests that the SMART-3RP program, which focuses on resilience, might be effective in supporting caregivers of children with learning disabilities.12345

Is the SMART-3RP program safe for caregivers of children with learning disabilities?

The SMART-3RP program, adapted for parents of children with learning and attentional disabilities, was found to be feasible and well-received when delivered virtually, suggesting it is generally safe for participants.678910

How is the SMART-3RP treatment different from other treatments for caregivers of children with learning disabilities?

The SMART-3RP treatment is unique because it focuses on building resilience and coping skills specifically for caregivers, helping them manage stress and enhance their social support networks, which is not typically the focus of other treatments for this condition.1112131415

What is the purpose of this trial?

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.

Research Team

ER

Elyse R Park, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: SMART-3RPExperimental Treatment1 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 ProgramActive Control1 Intervention
This is an adapted 8-session group program to provide health behavior education.

Find a Clinic Near You

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+

References

Stress and compliance with a home exercise program among caregivers of children with disabilities. [2006]
Enhancing resilience and self-efficacy in the parents of children with disabilities and complex health needs. [2020]
The Relationship Between Caregiver Burden and Resilience and Quality of Life in a Turkish Pediatric Rehabilitation Facility. [2021]
The experiences of families of children with learning disabilities: parental stress, family functioning, and sibling self-concept. [2022]
Psychiatric morbidity among informal caregivers of children suffering from intellectual developmental disorders. [2021]
Acceptability of a Virtual Mind-Body Intervention for Parents of Children With Autism or Learning Disabilities. [2022]
Impact of sleepwise: an intervention for youth with developmental disabilities and sleep disturbance. [2021]
The PRETEND Program: Evaluating the Feasibility of a Remote Parent-Training Intervention for Children With Prader-Willi Syndrome. [2019]
Psychological interventions in reducing stress, depression and anxiety among parents of children and adolescents with developmental disabilities: A systematic review and meta-analysis. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Hózhó: Promoting sleep health among Navajo caregivers. [2020]
Developing coping styles and social support networks: an intervention outcome study with mothers of handicapped children. [2019]
Impact of a family-centred early intervention programme in South India on caregivers of children with developmental delays. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Mothers of children with developmental disorders in the bedouin community in Israel: family functioning, caregiver burden, and coping abilities. [2022]
[Development of a New Resilience Scale for Parents of Children with Profound Intellectual and Multiple Disabilities]. [2022]
Perceived Stress and Coping Styles among Malay Caregivers of Children with Learning Disabilities in Kelantan. [2020]
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