Promoting Emotional Development Among Young Children Facing Adversity: An Effectiveness Implementation Study in St. Louis Schools
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Child Behavior Checklist
研究概览
简要总结
This study is designed to test the effectiveness and implementation of an early intervention therapy for children and their primary caregivers by using existing school counselors across several school districts.
The intervention is a 6-8 week caregiver-child intervention (THRIVE) which will be conducted via video conference in the family's home (i.e., zoom), or within the school setting (or a combination of those 2 modalities depending upon feasibility for the family). THRIVE will be compared to an asynchronous on-line parenting education program, Parenting Wisely (PW). This online parenting course will be accessed at www.parentingwisely.com.
Existing school counselors will be trained in the delivery of THRIVE to 3-7 year old children (in preschool, kindergarten and first grade) and their primary caregivers. In addition to testing the effectiveness of THRIVE compared to PW, we will also compare two implementation strategies: THRIVE-Coached and THRIVE-Low Coached (LC). We will assess ongoing coaching of THRIVE trainees to increase therapist efficacy and adherence to the intervention (THRIVE-Coached). This will be compared to implementation of THRIVE with low supports (e.g. weekly supervision) provided only for the first case following the initial training (THRIVE-LC].
Compared to those randomized to PW, we expect children who receive THRIVE will have significantly better behavioral and socio-emotional outcomes. Caregivers who receive THRIVE will experience less parenting stress and depression, more optimism and will show more nurturing, emotional tolerance, and supportive caregiving.
Therapists in the THRIVE-Coached condition will deliver the intervention with higher achieved outcomes and find the intervention to be more acceptable than therapists in the THRIVE-LC condition. Therapists in the THRIVE-Coached condition will be more likely to plan to sustain the intervention following the completion of the study than those in the THRIVE-LC condition. Parents and children receiving THRIVE from therapists in the THRIVE-Coached condition will have better socio-emotional outcomes than those in the THRIVE-LC and PW conditions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Near the clinical threshold on the Teacher or Parent Report Form
- •An active primary caregiver can be identified and is available to participate in the intervention (mother, father, grandparent or any adult in this role)
排除标准
- •Major neurological disorder
- •Participating in active weekly individual or family therapy
研究组 & 干预措施
THRIVE Coached
Thrive is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. It will be delivered by school social workers/counselors. Following training in THRIVE, school therapists in this condition will receive ongoing weekly group supervision over the life of the study.
干预措施: THRIVE (Behavioral)
THRIVE Low Coached
Thrive is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. It will be delivered by school social workers/counselors. Following training in THRIVE, school therapists in this condition will receive weekly group supervision only during thier first THRIVE case.
干预措施: THRIVE (Behavioral)
Parenting Wisely
Online asynchronous parenting training that parents will complete independently.
干预措施: Parenting Wisely (Behavioral)
结局指标
主要结局
Child Behavior Checklist
时间窗: T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention) and T4 (12 weeks post intervention)
Measure of child psychopathology/impairment (emotional and behavioral functioning). Raw scores are converted into T-scores. The T-scores range from 50 to 100, with higher scores indicating more problematic behaviors. T-scores above 65 indicate psychiatric symptoms.
次要结局
- The Emotion Regulation Checklist(T1 (baseline), T3 (completion of intervention))
- Coping with Children's Negative Emotions Scale(T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention))
- Parenting Stress Index(T1 (baseline), T3 (completion of intervention))
- Parent-Child Observed Interaction Coding(T1 (baseline), T3 (completion of intervention))
研究者
Joan Luby, MD
Professor of Psychiatry
Washington University School of Medicine