Pivotal Response Group Treatment for Parents of Young Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks
研究概览
简要总结
This is a research study examining the effectiveness of pivotal response treatment group (PRTG) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. The purpose of this study is to further examine the effectiveness of teaching pivotal response treatment to parents of children with autism in a group format. To determine the effectiveness of pivotal response training group (PRTG) it will be compared to another parent education group by conducting a randomized controlled 12-week trial.
详细描述
This is a research study examining the effectiveness of pivotal response treatment group (PRTG) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of teaching parents how to implement PRT in a group format, as opposed to an individual format. Preliminary data has demonstrated that teaching PRT in a group format has shown to be effective in teaching parents and increasing children's communication skills. The purpose of this study is to further examine the effectiveness of teaching pivotal response treatment to parents of children with autism in a group format. To determine the effectiveness of pivotal response training group (PRTG) it will be compared to another parent education group by conducting a randomized controlled 12-week trial. PRTG will aim to teach parents pivotal response training strategies, whereas the parent psychoeducational group (PEG) will aim to teach parents information with regards to assessment and treatment for children with autism. By conducting this research it will improve researchers understanding of group treatment options for individuals with autism and allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families.
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview - Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), and expert clinical opinion
- •Outpatients between 2.0 and 6 years of age of either gender
- •Children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained
- •Language delay as measured by the Preschool Language Scale 4th ed. (PLS-4)
- •Participants must have the ability to make meaningful vocalizations, defined as the ability to make contingent vocalizations when prompted (i.e., vocal sound showing intent to communicate, but not necessarily clear words)
- •Stable psychotropic medication(s) or biomedical interventions for at least one month prior to baseline measurements with no anticipated changes during study participation
- •Stable behavioral treatment (Applied Behavioral Analysis, Floortime, or other interventions), speech therapy, and school placement for at least 2 months prior to baseline measurements with no expected changes during study participation
- •No more than 60 minutes of 1:1 speech therapy per week
- •The availability of at least one parent who can consistently participate in the group treatment and related activities of the research study
- •Be male or female in good medical health
- •Will be starting PRTG after the first magnetic resonance image (MRI) scan has occured and, if agreeable, blood draw or saliva sample
- •Parents intend on continuing PRTG for a minimum of 12 weeks
- •Parents must be 18 years of age or older.
排除标准
- •A current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder...)
- •A genetic abnormality, such as Fragile X, based on genetic testing, done as indicated
- •Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
- •Participants taking psychotropic medications will not be included if their medications have not been stable for over a week
- •Parents who do not have the ability to videotape parent and child interactions on a weekly basis
- •Parents who are not willing to implement intervention strategies for at least one hour a day
- •Parents who plan to alternate which parent attends the group sessions.
研究组 & 干预措施
Pivotal Response Training (PRT)
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
干预措施: Pivotal Response Training (PRT) (Behavioral)
Parent Education Group (PEG)
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
干预措施: Parent Education Group (PEG) (Behavioral)
结局指标
主要结局
Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks
时间窗: Baseline, 12 weeks
Total frequency of child's utterances during 10 minute videotaped SLO assessment.
次要结局
- Family Empowerment Scale Total Score(Baseline, 12 weeks)
- Parenting Stress Index Total Score(Baseline, 12 weeks)
- Pediatric Quality of Life Scale Scaled Total Mean Score(Baseline, 12 weeks)
- Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score(Baseline, 12 weeks)
- Repetitive Behavior Scale- Revised Total Score(Baseline, 12 weeks)
- Sensory Profile Questionnaire Sensory Seeking Raw Score(Baseline, 12 weeks)
研究者
Antonio Hardan
Professor
Stanford University