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| ID | Type | Description | Link |
|---|---|---|---|
| 1R56AT011869-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART-3RP | Experimental | This is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD. |
|
| Health Education Program | Active Comparator | This is an adapted 8-session group program to provide health behavior education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMART-3RP | Behavioral | The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elyse R Park, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42137451 | Derived | Park ER, Goshe BM, Miranda I, Finkelstein-Fox L, Nourse P, Williams R, Nicolosi G, Lopez K, de la Cruz R, Barreto E, Millstein RA, Perez GK, Mahaffey B, Abuelo C, Winklosky B, Rippey R, Kuhlthau KA. Feasibility and Acceptability of Group-Based Interventions (Offered in English and Spanish) for Caregivers of Children With LAD. Glob Adv Integr Med Health. 2026 May 8;15:27536130261442880. doi: 10.1177/27536130261442880. eCollection 2026 Jan-Dec. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SMART-3RP | This is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD. |
| FG001 | Health Education Program | This is an adapted 8-session group program to provide health behavior education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SMART-3RP | This is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD. |
| BG001 | Health Education Program | This is an adapted 8-session group program to provide health behavior education. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Study Enrollment | Number of participants enrolled in the study, of those eligible | All participants screened eligible to participate | Posted | Count of Participants | Participants | Baseline |
|
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From enrollment until end of follow-up (approximately 8-10 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SMART-3RP | This is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elyse Park, PhD MPH | Mass General Brigham | 617-724-6836 | epark@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2025 | Feb 18, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 25, 2024 | Feb 18, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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. |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Preferred Language | Preference for participating in English- or Spanish-speaking group | Count of Participants | Participants |
|
|
| Primary | 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) | Please note that 25 participants (of 28 randomized) attended at least one group session and are thus included in analyses reported here. | Posted | Count of Participants | Participants | Approximately 3 months (approximately 8-10 weeks after intervention start) |
|
|
|
| Primary | Feasibility of Intervention Attendance (% Attending at Least 4 of 8 Sessions) | Number of participants attending at least 4 of 8 group meetings | Please note that 25 participants (of 28 randomized) attended at least one group session and are thus included in analyses reported here. | Posted | Count of Participants | Participants | Approximately 3 months (approximately 8-10 weeks after intervention start) |
|
|
|
| Primary | Feasibility of Follow-up Survey Completion | Number of participants providing follow-up surveys after group completion | This index includes participants who agreed to complete study surveys despite not attending group sessions (intent-to-treat analysis); as such, all 28 participants who were randomized to either SMART-3RP or HEP are included. | Posted | Count of Participants | Participants | Approximately 3 months (8-10 weeks) post-enrollment |
|
|
|
| Primary | 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. | Please note that 24 participants (of 28 randomized) attended at least one group session and have available data, and are thus included in analyses reported here. | Posted | Count of Participants | Participants | Approximately 3 months (approximately 8-10 weeks after intervention start) |
|
|
|
| Primary | 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. | Please note that 24 participants (of 28 randomized) attended at least one group session and have available data, and are thus included in analyses reported here. | Posted | Count of Participants | Participants | Approximately 3 months (8-10 weeks) post-enrollment |
|
|
|
| Primary | 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. | Please note that 23 participants (of 28 randomized) attended at least one group session and have available data and are thus included in analyses reported here. | Posted | Count of Participants | Participants | Approximately 3 months (8-10 weeks) post-enrollment |
|
|
|
| Primary | 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. | Please note that 24 participants (of 28 randomized) attended at least one group session and have available data, and are thus included in analyses reported here. | Posted | Count of Participants | Participants | Approximately 3 months (8-10 weeks) post-enrollment |
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|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Health Education Program | This is an adapted 8-session group program to provide health behavior education. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |