Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties

NCT06492278 | Completed Results

• 2 other identifiers: 2024P0012191R56AT011869-01A1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting; Stress; Learning Disabilities, Child; Attention Difficulties

Keywords

Resiliency training; Stress management; Learning and attentional disabilities

Outcome Measures

Primary Outcomes (8)

• Feasibility of Study Enrollment

  Number of participants enrolled in the study, of those eligible

  Baseline

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

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

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

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

  Number of participants attending at least 4 of 8 group meetings

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

• Feasibility of Follow-up Survey Completion

  Number of participants providing follow-up surveys after group completion

  Approximately 3 months (8-10 weeks) post-enrollment

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

  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.

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

• Acceptability of Number of Sessions

  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.

  Approximately 3 months (8-10 weeks) post-enrollment

• Acceptability of Teleconferencing Delivery

  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.

  Approximately 3 months (8-10 weeks) post-enrollment

• Acceptability- Group Cohesiveness

  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.

  Approximately 3 months (8-10 weeks) post-enrollment

Study Arms (2)

SMART-3RP

EXPERIMENTAL

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

Behavioral: SMART-3RP

Health Education Program

ACTIVE COMPARATOR

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

Behavioral: Health Education Program

Interventions

SMART-3RP BEHAVIORAL

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

SMART-3RP

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.

Health Education Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

MGH

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Elyse Park, PhD MPH
• Organization: Mass General Brigham

epark@mgh.harvard.edu

617-724-6836

Study Officials

• Elyse R Park, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 9, 2024
• Study Start: November 1, 2024
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)