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Completed

NCT Number: NCT06492278

Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties

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.

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Key information

Conditions

Parenting Attention Difficulties Communication Disorders Learning Disabilities Learning Disabilities, Child Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MGH

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMART-3RP

Behavioral

The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

Health Education Program

Behavioral

This is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team.

Primary outcomes

  1. Feasibility of Study Enrollment

    Time frame: Baseline

    Number of participants enrolled in the study, of those eligible

  2. Feasibility of Intervention Attendance (% Attending at Least 6 of 8 Sessions)

    Time frame: Approximately 3 months (approximately 8-10 weeks after intervention start)

    Number of participants attending at least 6 of 8 group meetings (of those who attended at least 1 group session)

  3. Feasibility of Intervention Attendance (% Attending at Least 4 of 8 Sessions)

    Time frame: Approximately 3 months (approximately 8-10 weeks after intervention start)

    Number of participants attending at least 4 of 8 group meetings

  4. Feasibility of Follow-up Survey Completion

    Time frame: Approximately 3 months (8-10 weeks) post-enrollment

    Number of participants providing follow-up surveys after group completion

  5. Acceptability of the Refined Intervention Content (SMART-3RP and HEP)

    Time frame: Approximately 3 months (approximately 8-10 weeks after intervention start)

    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.

  6. Acceptability of Number of Sessions

    Time frame: Approximately 3 months (8-10 weeks) post-enrollment

    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.

  7. Acceptability of Teleconferencing Delivery

    Time frame: Approximately 3 months (8-10 weeks) post-enrollment

    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.

  8. Acceptability- Group Cohesiveness

    Time frame: Approximately 3 months (8-10 weeks) post-enrollment

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Acronym: SPARK

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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