The Effects of Parent-based IMPACT Intervention for Autism Sprectrum Disorder and Its Related Neural Mechanism
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Autism Symptom Severity as measured by ADOS-2 Comparison Score and Subscales
研究概览
简要总结
Purpose of the Research:
The goal of this clinical study is to investigate if a parent training program called "Project IMPACT" (Improving Parents as Communication Teachers) can help improve the core challenges in social interaction and communication for children with Autism Spectrum Disorder (ASD). And to explore whether and how this intervention affects children's brain activity.
Key Questions This Study Aims to Answer:
Does participation in the IMPACT parent training program significantly improve ASD symptoms, social communication abilities, and adaptive functioning in daily life for children with ASD compared to general intervention?
Study Design:
This is a assessor blinding randomized controlled trial. Participating children will be randomly assigned to one of two groups: IMPACT Intervention Group with primary caregiver conducting intervention and Control Group with current routine interventions provided by behavioral trainers.
The research team will evaluate all children at three time points: before the intervention starts, immediately after the 10 - week intervention period, and 6 months after the intervention ends. The measurements include social - related questionnaires, ADOS - 2, Griffiths Scales, eye - tracking, task - based fNIRS, and fMRI without sedation.
详细描述
Purpose of the Research:
The goal of this clinical study is to investigate if a parent training program called "Project IMPACT" (Improving Parents as Communication Teachers) can help improve the core challenges in social interaction and communication for children with Autism Spectrum Disorder (ASD). And to explore whether and how this intervention affects children's brain activity. We will use safe brain imaging techniques (such as MRI and functional Near-Infrared Spectroscopy, fNIRS) to compare changes in the brain before and after the intervention, aiming to understand the potential brain mechanisms behind behavioral progress. Ultimately, we hope to identify which types of children might benefit most from this intervention, providing insights for more personalized treatment recommendations in the future.
Key Questions This Study Aims to Answer:
Does participation in the IMPACT parent training program significantly improve ASD symptoms, social communication abilities, and adaptive functioning in daily life for children with ASD compared to general intervention?
Study Design:
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
- 18 Months 至 78 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be between the ages of 18 months and 78 months (6.5 years) at the time of enrollment.
- •Participants must have received a formal diagnosis of autism spectrum disorder (or meet criteria for conditions within the autism spectrum) from qualified clinicians, such as psychiatrists or pediatricians, in accordance with the diagnostic criteria specified in either the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) or the International Classification of Diseases, 11th Revision (ICD-11).
- •Participants must have a score meeting the autism spectrum cutoff on the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).
- •At least one parent is able to participate in the entire assessment and intervention procedure.
排除标准
- •Presence of a comorbid major neurological disorder (e.g., epilepsy, cerebral palsy) or a severe psychiatric condition.
- •A history of significant brain injury or trauma.
- •Current use of psychotropic medication or a within 3 months history of receiving transcranial electrical/magnetic stimulation therapy.
- •Significant uncorrected impairment in visual or auditory acuity.
- •Motor function disorders.
研究组 & 干预措施
ImPACT-based Interventions
Parent-based behavioral interventions for children.
干预措施: Parents conducted interventions based on project ImPACT. (Behavioral)
General interventions
Current routine interventions provided by behavioral trainers.
干预措施: General behavioral interventions (Behavioral)
结局指标
主要结局
Change in Autism Symptom Severity as measured by ADOS-2 Comparison Score and Subscales
时间窗: From enrollment to the end of treatment at 10 weeks.
The ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition) is a semi-structured, standardized assessment of communication, social interaction, play, and restricted and repetitive behaviors. The Comparison Score is a standardized metric used to compare autism severity across different modules and ages. The Comparison Score ranges from 1 to 10, with higher scores indicating greater severity of autism spectrum-related symptoms (worse outcome).
Change in Social Impairment as measured by the Social Responsiveness Scale, Second Edition (SRS-2) Total Score
时间窗: From enrollment to the end of treatment at 10 weeks, 3months after treatment.
The SRS-2 is a 65-item caregiver-completed rating scale that measures the severity of autism spectrum symptoms as they occur in natural social settings. Each item is scored on a 4-point Likert scale ranging from 0 (Never True) to 3 (Almost Always True). The Total Raw Score is calculated by summing the scores of all 65 items. The total raw score ranges from 0 to 195, with higher scores indicating greater severity of social impairment (worse outcome).
Change in Child PFC Activation (Oxy-Hb) during Parent-Child Interaction
时间窗: From enrollment to the end of treatment at 10 weeks.
Mean Oxygenated Hemoglobin (Oxy-Hb) concentration in the Prefrontal Cortex (PFC) collected while the child engages in a standardized play task with their parent. Higher concentration indicates greater activation.
Change in Social Visual Preference Index (Percentage of Fixation Duration)
时间窗: From enrollment to the end of treatment at 10 weeks.
Participants view a battery of 3 paired paradigms presenting simultaneous social and non-social stimuli. The index is calculated as the percentage of total fixation duration spent on Social Areas of Interest (AOIs) divided by the total fixation duration on both Social and Non-social AOIs. Formula: (Duration on Social / (Duration on Social + Duration on Non-social)) \* 100. The score is averaged across the 3 paradigms. Values range from 0 to 100%. Higher scores indicate a stronger preference for social stimuli.
次要结局
- Change in Adaptive Functioning as measured by the ABAS-II General Adaptive Composite (GAC) and Domain Scores(From enrollment to the end of treatment at 10 weeks.)
- Change in Structural Brain Volume (Gray Matter Volume) in Regions of Interest (e.g., Prefrontal Cortex, Amygdala(From enrollment to the end of treatment at 10 weeks.)
- Change in Caregiver Burden as measured by the Caregiver Strain Questionnaire (CSQ) Total Score(From enrollment to the end of treatment at 10 weeks.)
- Change in Intrinsic Functional Connectivity (Resting State fMRI)(Baseline and Week 10)
- Change in Parenting Sense of Competence (PSOC): Total Score and Subscales(From enrollment to the end of treatment at 10 weeks.)
- Change in Repetitive Behaviors as measured by the Repetitive Behavior Scale-Revised (RBS-R) Total Score(From enrollment to the end of treatment at 10 weeks)
- Change in Social Communication Skills as measured by the Project ImPACT Social Communication Checklist (Parent-Reported)(From enrollment to the end of treatment at 10 weeks.)
- ADOS-2 Raw Scores (Module 1 and Module 2)(Baseline and Week 10)
- Change in Child PFC Activation (Oxy-Hb) during Interaction with Therapist(Baseline and Week 10)
- Change in Child PFC Activation (Oxy-Hb) during Solitary Play(Baseline and Week 10)
- Change in Social Orienting Index (Percentage of Fixation Counts)(Baseline and Week 10.)
- Change in Parent Intervention Fidelity as measured by the Project ImPACT Fidelity of Implementation Rating Scale(Baseline and Week 10)
- Change in Social Communication Skills as measured by the Project ImPACT Social Communication Checklist (Teacher/Coach-Reported)(Baseline and Week 10)
研究者
Weihua Zhao
Associate researcher
University of Electronic Science and Technology of China