A Pilot Study of Primary Care Stepping Stones Triple P for Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change from Baseline in Parent Stress Index - Short Form Score at 4 weeks
研究概览
简要总结
The purpose of this study is to determine the effectiveness of Primary Care Stepping Stones Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years), increase parental resilience and decrease parental stress.
详细描述
Research literature exists on best practices for screening and diagnosing children with Autism. However, less is known about how to intervene with the child's parent. Across studies, relative to parents of children without disabilities, parents of children with Autism have reported higher levels of stress and lower levels of parenting competence. Such stress places children at risk for adverse developmental outcomes
The proposed study aims to determine the effectiveness of Primary Care Stepping Stones Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years), increase parental resilience and decrease parental stress.
The specific hypotheses include:
- Children whose parents receive PC-SS Triple P will demonstrate significantly greater improvements in their behavioral functioning than children of parents receiving Wait-list Control (WLC) at service closure.
- At service closure, parents receiving the PC-SS Triple P intervention will be more resilient and demonstrate lower levels of stress than parents in the Wait-List Control (WLC) condition.
- Parenting resilience and levels of parental stress will be positively associated with improvements in child behavior.
Seventy-six parents of children newly diagnosed with Autism will be randomized into one of two conditions: a) PC-SS Triple P (N=38) or b) Wait List Control (WLC; N=38). Study data will be collected with the assistance of a data collector appropriately trained in human subject rights protections.
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
- •Parent inclusion criteria:
- •being at least 18 years of age
- •Index child inclusion criteria:
- •receives a Diagnostic and Statistical Manual V (DSM-V) diagnosis of Autism with mild or moderate severity within 12 months of study onset.
- •age is > or equal to 24 months (2 years, 0 months) and < or equal to 155 months old (12 years, 11 months).
排除标准
- •Parent exclusion criteria:
- •inability to provide informed consent.
- •being non-English speaking.
- •Index child exclusion criteria:
- •being a ward of the State of Missouri.
- •being a sibling of another study participant.
研究组 & 干预措施
Primary Care Stepping Stones Triple P
Primary Care Stepping Stones Triple P program (PC-SS Triple P) - a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience.
干预措施: Primary Care Stepping Stones Triple P (PC-SS Triple P) (Behavioral)
Wait List Control (WLC)
Wait List Control - Participants who will have access to treatment as usual services during the 4 weeks between baseline and 4 week assessment time points and then will have the opportunity to receive PC-SS Triple P.
干预措施: Treatment as Usual (Other)
结局指标
主要结局
Change from Baseline in Parent Stress Index - Short Form Score at 4 weeks
时间窗: Baseline and 4 weeks
Sources and different types of stress that every parent can experience. Provides information in 4 specific domains of parenting stress: 1. Parental Distress, 2. Parent-Child Dysfunctional Interaction, 3. Difficult Child, and 4. Total Stress.
Change from Baseline in Family Assessment Device score at 4 weeks
时间窗: Baseline and 4 weeks
Assesses family functioning on six different dimensions: 1. Problem Solving (ability to resolve problems), 2. Communication (exchange of clear and direct verbal information), 3. Roles (division of responsibility for completing family tasks), 4. Affective Responsiveness (ability to respond with appropriate emotion), 5. Affective Involvement (degree to which family members are involved and interested in one another), and 6. Behavior Control (manner used to express and maintain standards of behavior).
Change from Baseline in Eyberg Child Behavior Inventory Score at 4 weeks
时间窗: Baseline and 4 weeks
Measure conduct problem behavior in children between the ages of 2 and 16 years.
Change from Baseline in Connor-Davidson Resilience Scale Score at 4 weeks
时间窗: Baseline and 4 weeks
General scale of resilience in adult populations with a bias towards coping with stress and adversity.
次要结局
- Change from Baseline in Aberrant Behavior Checklist Score at 4 weeks(Baseline and 4 weeks)
- Change from Baseline in The Parenting Scale Score at 4 weeks(Baseline and 4 weeks)
- Change from Baseline in the Parenting Sense of Competence Scale Score at 4 weeks(Baseline and 4 weeks)
研究者
Debra H. Zand, Ph.D.
Associate Professor of Pediatrics
St. Louis University