Implementing a Resilience Program in a Trauma-Informed Preschool Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Resilience and Engagement
研究概览
简要总结
# Brief Summary
The goal of this clinical trial is to learn if a occupational therapy-led trauma-informed care intervention can improve resilience, self-regulation, coping skills, and emotional health in preschoolers ages 2-4 years from under-resourced neighborhoods with a history of adverse childhood experiences (ACEs) and their caregivers. The main questions it aims to answer are:
- Does the Building Resilience Program (BRP) improve stress management, self-regulation, positive affect, engagement, self-efficacy, coping skills and resilience in preschool children?
- Does the Building Resilience Program (BRP) improve resilience, emotional management, and coping strategies in caregivers?
Researchers will compare the Building Resilience Program group to a school readiness skills comparison group to see if the trauma-informed intervention produces greater improvements in resilience and related outcomes.
Participants will:
- Complete pre- and post-intervention assessments measuring resilience, coping skills, emotional health, occupational engagement, and quality of life
- Attend 40-60 minute group sessions, 3x a week for 8 weeks (children will participate in either the BRP intervention or school readiness comparison group)
- Complete individualized Goal Attainment Scaling to track personal progress (children)
- Attend 2-3 in-person caregiver group sessions during the 8-week intervention period plus pre- and post-intervention meetings (caregivers)
- Complete a program evaluation questionnaire at the end of the study (caregivers)
详细描述
Background and Rationale Children living in under-resourced, poverty-stricken neighborhoods face significantly higher risks for adverse childhood experiences (ACEs) and trauma. In the East Cleveland, Ohio neighborhoods where this study will be conducted, poverty affects 36.5%- 41.6% of residents respectively, compared to the national average of 11.9%. Among neighborhood children, 52.8% to 54.9% live in poverty, with upwards of 80% being Black minorities. More than half of residents qualify for foodbank benefits and less than half have secure, affordable housing.
ACEs related to poverty and low socioeconomic status include experiencing abuse, neglect, witnessing violence or mental illness, food or housing instability, and incarceration of a parent or caregiver. These experiences can severely impact overall quality of life, mental health, and often lead to developmental delays and long-term effects. When parents themselves were impacted by ACEs, it can lead to intergenerational transmission of negative effects.
The American Academy of Pediatrics has specifically identified the critical need to provide interventions that build resilience and address maladaptive responses due to toxic stress resulting from ACEs. Occupational therapists are particularly well-suited to integrate trauma-informed care (TIC) into service delivery through direct intervention and by embedding strategies within occupational engagement, particularly through play as the primary occupation for young children.
Study Design and Innovation This pilot study builds on a prior feasibility study conducted at the YWCA (Young Women's Christian Association) of Cleveland between April-June 2022. The Building Resilience Program (BRP) manual was originally developed for school-age children with chronic pain and was modified to be age and content appropriate for preschoolers ages 2-4 years with trauma history.
The study employs a randomized two-group pre-posttest comparison waitlist design. Given the maximum enrollment of approximately 40 participants at the YWCA Early Learning Center, the study cannot account for all factors that could introduce bias, but the use of a comparison, non-BRP condition will allow comparison between groups over time and account for potential maturation effects. The comparison group will participate in a basic school readiness skills group that excludes resilience training components to avoid contaminating the intervention protocol while providing similar positive adult interactions that could introduce bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Months 至 66 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled at the YWCA Early Learning Center partner facility, between the ages of 24 months and 66 months at the time of enrollment
排除标准
- •limited English-speaking fluency (i.e., required a translator), or parent-reported cognitive delays or medical conditions that would prevent independent participation in the program groups
研究组 & 干预措施
Intervention - children receiving the 8-week Building Resilience Program
Out-of-classroom, small group intervention led by occupational therapists, implementation of the manualized BRP
干预措施: Mental health, positive coping strategies promoting self-regulation and adaptive skills (Behavioral)
Standard care or school readiness condition
This condition for the waitlist control condition was used to account for positive effects that might have been the result of interactions with an occupational therapist. This was designed specifically NOT to overlap with the constructs of the intervention condition and focused on other, more basic elements of school readiness unrelated to mental health, social emotional learning or trauma.
干预措施: Standard care/School Readiness Condition (Other)
结局指标
主要结局
Resilience and Engagement
时间窗: Measured at baseline, week 8 (end of first intervention and wait-list period), and finally at week 16 (end of second intervention period for the waitlist group and follow-up period for the first intervention group)
Patient-Reported Outcomes Measurement Information System (PROMIS) Curiosity and Persistence measures (parent proxy report, scores calculated as standardized scores for analysis). Original scoring for all is 1-5 scale (Never, Rarely, Sometimes, Often, Always). Higher scores (always/5) are considered higher and more characteristic of a child with characteristics of being resilient.
Self-Regulation
时间窗: Measured at baseline, week 8 (end of first intervention and wait-list period), and finally at week 16 (end of second intervention period for the waitlist group and follow-up period for the first intervention group)
Patient-Reported Outcomes Measurement Information System (PROMIS) Flexibility and Frustration Tolerance measures (parent proxy report, scores calculated as standardized scores for analysis). Original scoring for all is 1-5 scale (Never, Rarely, Sometimes, Often, Always). Higher scores (always/5) are considered higher and more characteristic of a child with characteristics of being resilient.
Emotional Health
时间窗: Measured at baseline, week 8 (end of first intervention and wait-list period), and finally at week 16 (end of second intervention period for the waitlist group and follow-up period for the first intervention group)
Measured using NIH Toolbox parent proxy report measures for (1) Positive Affect; (2) Anger; (3) Fear; (4) Sadness. Positive Affect rated on 1-4 scale: (1) Not at all (1) A little bit (2) Somewhat (3) Quite a bit and (4) Very much. Anger rated on 1-3 scale: (1) Never or not true, (2) Sometimes or somewhat true, (3) Often or very true. Fear and Sadness rated on a 0-2 scale, (0) Never or not true, (1) Sometimes or somewhat true, (2) Often or very true. All were converted to standardized scores for analysis according to the NIH Toolbox directions for scoring.
Quality of Life/Life Satisfaction
时间窗: Measured at baseline, week 8 (end of first intervention and wait-list period), and finally at week 16 (end of second intervention period for the waitlist group and follow-up period for the first intervention group).
NIH Toolbox measures for General Life Satisfaction parent proxy report measured on a 1-5 scale of (1) Strongly Disagree, (2) Disagree, (3) Neither Agree nor Disagree, (4) Agree, (5) Strongly Agree. All scores converted to standardized scores for analysis according to the NIH Toolbox scoring guide.
Quality of Life (QoL)
时间窗: Measured at baseline, week 8 (end of first intervention and wait-list period), and finally at week 16 (end of second intervention period for the waitlist group and follow-up period for the first intervention group)
QoL as measured by parent proxy report on the PedsQL including the following domains: Physical, Emotional, Social, School, and a Composite score. Each of these was rated on a scale of 0-4, (0) Never, (1) Almost Never (2) Sometimes (3) Often (4) Almost Always. Scores were translated into standardized scores for analysis according to PedsQL scoring guidelines.
Individualized Goal Attainment Scaling (GAS) goals
时间窗: GAS scores recorded at baseline, and then 3x per week for 8 weeks during the intervention condition, and 2x per week during the waitlist control condition, across all GAS categories (behavior, engagement/participation and resilience).
Goals were created for each individual participant related to: behavior, engagement/participation and resilience. Goal Attainment Scaling (GAS) was used to track progress and attainment throughout the project, recorded by members of the research team. Scoring was consistent with typical GAS ratings: a 5-point scale, ranging from -2 to +2, to assess progress toward a specific goal. The 0 level represents the expected outcome with intervention, while -1 and -2 indicate less-than-expected progress or a return to a baseline, and +1 and +2 show progress that exceeds expectations. These ratings were converted to T-scores for analysis (mean 50, SD 10).
次要结局
- Caregiver Well-Being(Measurement taken at baseline and again post-caregiver intervention at week 8 or week 16, depending on group assignment for their child (caregivers participated in intervention during same 8-week timeframe as their child).)
- Caregiver - Resilience(Measurements taken and baseline and then post-intervention (either week 8 or 16 depending on group assignment))
- Caregiver Perceptions(Caregivers and educators provided consent at baseline, interviews completed after program completed between weeks 16-20, based on scheduling limitations and availability. Interviews schedule for 60 minutes.)
研究者
Kelle DeBoth Foust
Associate Professor
Cleveland State University