Open Pilot Trial of a Resiliency Group Program for Caregivers of Children With Learning and Attentional Difficulties: Supporting Parents Raising Kids (SPARK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Feasibility of the refined interventions (SMART-3RP and HEP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
SMART-3RP
This is an adapted 8-session group program of the Relaxation Response Resiliency Program (3RP) for parents of children with LAD.
干预措施: SMART-3RP (Behavioral)
Health Education Program
This is an adapted 8-session group program to provide health behavior education.
干预措施: Health Education Program (Behavioral)
结局指标
主要结局
Feasibility of the refined interventions (SMART-3RP and HEP)
时间窗: Approximately 3 months (approximately 8-10 weeks after intervention start)
Rates of intervention attendance (# of sessions), rates of participant recruitment (%) enrollment, survey completion rates (%).
Acceptability of the refined interventions (SMART-3RP and HEP)
时间窗: Approximately 3 months (approximately 8-10 weeks after intervention start)
Likert ratings of group comfort and cohesiveness.
Feasibility of Study Enrollment
时间窗: Baseline
Number of participants enrolled in the study, of those eligible
Feasibility of Intervention Attendance (% Attending at Least 6 of 8 Sessions)
时间窗: 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)
时间窗: 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
时间窗: Approximately 3 months (8-10 weeks) post-enrollment
Number of participants providing follow-up surveys after group completion
Acceptability of Number of Sessions
时间窗: 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 the Refined Intervention Content (SMART-3RP and HEP)
时间窗: 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 Teleconferencing Delivery
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Elyse Park, PhD
Professor of Psychology
Massachusetts General Hospital