Assessing the Feasibility, Acceptability, and Preliminary Efficacy of an Adaptive Intervention Approach for Children With Autism and Disruptive Behavior: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Number of children referred to the study each month meeting eligibility requirements
研究概览
简要总结
Investigators seek to transform the delivery of health care to children with autism spectrum disorder (ASD) and behavioral health problems (and their families) by developing an innovative tiered set of interventions. Investigators aim to demonstrate that for children with ASD and disruptive behavior a family navigation-based intervention (autism behavioral health navigation; ABHN) will be feasible and more acceptable to families than brief social work consultation. For children with persistent disruptive behavior despite the social work or ABHN intervention Investigators will evaluate the feasibility and acceptability of adding consultation with an interprofessional team of ASD experts.
详细描述
Context: It is often challenging to help families of children with autism spectrum disorder (ASD) manage disruptive behaviors. Family navigation and interprofessional care are promising care strategies that could be applied to care for these children.
Objectives: Investigators aim to demonstrate that for children with ASD and disruptive behavior a family navigation-based intervention (autism behavioral health navigation; ABHN) will be feasible and more acceptable to families than brief social work consultation. For persistent disruptive behavior despite the social work or ABHN intervention we will evaluate the feasibility and acceptability of adding consultation with an interprofessional team of ASD experts (Complex Autism Program; CAP).
Study Design: Investigators will conduct a Sequential Multiple Assignment Randomized Trial (SMART) of social work consultation, ABHN, and ABHN+CAP.
Setting/Participants:Participants will be children age 5-12 years, diagnosed with an ASD, receiving care for ASD at the Children's Hospital of Philadelphia (CHOP) in the Division of Developmental and Behavioral Pediatrics (DBP), Division of Neurology, or in the Department of Child and Adolescent Psychiatry and Behavioral Sciences (DCAPBS), and exhibiting high levels of disruptive behaviors (defined as an elevated score on the Aberrant Behavior Checklist (ABC) Irritability subscale and an elevated score on the Clinical Global Impression - Severity (CGI-S)). A parent of the child involved in coordinating the child's care will also be a participant in the study.
Study Interventions and Measures: Interventions include brief social work consultation, ABHN, and an interprofessional evaluation. The primary outcome measure will be the Aberrant Behavior Checklist (ABC) Irritability subscale. Secondary measures include the Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S and CGI-I), parent ratings of child behavior, parenting stress, and measures of feasibility and acceptability.
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 (Participant)
盲法说明
Given the nature of the intervention families will not be blind to the intervention they are receiving. During phase 1 the investigator providing the clinical global impression (CGI) scores will be blind to the child's group assignment. Families will be asked not to discuss their work with a social worker or ABHN when completing interview questions at the interim assessments.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is age 5 through 12 years 11 months
- •Diagnosed with autism spectrum disorder (ASD) and receives care for ASD at the Children's Hospital of Philadelphia (CHOP) in Developmental and Behavioral Pediatrics (DBP) or Child Neurology, or in Department of Child and Adolescent Psychiatry and Behavioral Sciences (DCAPBS)
- •Child exhibits disruptive behaviors characterized by tantrums, outbursts, self-injurious, or aggressive behaviors with a Clinical Global Impression severity (CGI-S) for the disruptive behavior of at least 4
- •A caregiver completed Aberrant Behavior Checklist (ABC-2) Irritability subscale score is greater than 13
- •A parent of the child who is involved in coordinating the child's care will also participate as a research subject.
排除标准
- •Child requires crisis intervention or urgent psychiatric consultation
- •Referring physician or psychologist will not be providing ongoing management of the child's behavioral challenges.
- •Parent needs a different intervention or type of assistance than will be available through the study
- •Families who live outside a 40 mile radius from the Children's Hospital of Philadelphia (CHOP -main)
结局指标
主要结局
Number of children referred to the study each month meeting eligibility requirements
时间窗: 9 months
Prescribing clinicians from the following Divisions and Departments (DBP, Neurology, DCAPBS) will refer patients age 5-12 with ASD and disruptive behavior to the study. The number of children referred will be determined by counting the participants in the study who meet the inclusion criteria.
次要结局
- Changes in levels of challenging behavior(6 months)
- Number of families successfully contacted by the navigator or social worker(9 months)
- Retention Rate(9 months)
- Changes in ABC-irritability subscale(6 months)
- Number of subjects consented(9 months)
- Changes (or Improvement) with interpersonal relationships(9 months)