Attention Difficulties, Learning Disabilities, Child, Parenting, Stress
Conditions
Keywords
Resiliency training, Stress management, Learning and attentional disabilities
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.
Detailed description
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.
Interventions
BEHAVIORALSMART-3RP
The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
BEHAVIORALHealth Education Program
This is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team.
Sponsors
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Study Enrollment | Baseline | Number of participants enrolled in the study, of those eligible |
| Feasibility of Intervention Attendance (% Attending at Least 6 of 8 Sessions) | 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) |
| Feasibility of Intervention Attendance (% Attending at Least 4 of 8 Sessions) | Approximately 3 months (approximately 8-10 weeks after intervention start) | Number of participants attending at least 4 of 8 group meetings |
| Feasibility of Follow-up Survey Completion | Approximately 3 months (8-10 weeks) post-enrollment | Number of participants providing follow-up surveys after group completion |
| Acceptability of the Refined Intervention Content (SMART-3RP and HEP) | 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. |
| Acceptability of Number of Sessions | 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. |
| Acceptability of Teleconferencing Delivery | 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. |
| Acceptability- Group Cohesiveness | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElyse R Park, PhD
Massachusetts General Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43.8 Years STANDARD_DEVIATION 9.2 |
| Preferred Language English | 8 Participants |
| Preferred Language Spanish | 5 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 7 Participants |
| Race/Ethnicity, Customized Not Hispanic/Latino | 13 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 13 |
| other Total, other adverse events | 0 / 15 | 0 / 13 |
| serious Total, serious adverse events | 0 / 15 | 0 / 13 |
Outcome results
None listed