Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Clinical Global Impression
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of an adapted, telehealth functional behavioral therapy (FBTsIDD) specifically focused on promoting appropriate communication and behavioral strategies in individuals with syndromic intellectual and developmental disorders.
Participants will be asked to complete virtual study assessments at intake and then on a monthly basis for the duration of 3-6 months. In addition, participants will attend weekly or biweekly virtual intervention visits with a study therapist.
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age(s) 2-12 years old at time of enrollment
- •Existing genetic syndrome based on clinical or genetic diagnosis and confirmed by medical records
- •Documented diagnosis of global developmental delay (GDD) or intellectual disability (ID)
- •estimated ID in all ranges
- •Disruptive behavior challenges determined to be clinically appropriate for remote, parent-implemented coaching based on clinician determination of acuity of problem behaviors
- •Caregiver who is able to consent in English.
- •Parent/caregiver available for weekly intervention sessions
- •Stable psychosocial and psychiatric treatments 3 months prior to baseline visit.
排除标准
- •High levels of aggression that mitigate remote or outpatient treatment as defined by clinician judgement and/or ABC Irritability scores above 20 (i.e., higher level of care needed than provided by study procedures)
- •Medical or psychiatric instability that may limit study participation
- •Meaningful change in medication or psychosocial interventions 3 months prior to baseline visit
- •Limitations in technology access that may hinder participation in remote trial (e.g., declining support provided by study participation)
研究组 & 干预措施
Positive Parenting Strategies-Treatment As Usual
干预措施: Positive Parenting Strategies-Treatment as Usual (Other)
Functional Behavioral Training
干预措施: Functional Behavioral Training (FBT) (Behavioral)
结局指标
主要结局
Clinical Global Impression
时间窗: TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6)
Overall functioning will be measured using the Clinical Global Impression for Severity (CGI-S) and Improvement (CGl-I). GCI-S will be recorded at Baseline with CGI-S and CGI-I collected at all determined visits. The CGI provides a rating of the child's global functioning, taking into account all available information (e.g., child's symptoms, behavior, functioning). The CGI-S and CGl-I will be completed by a blinded independent evaluator.
次要结局
- Parent Target Problems (PTP) Inventory(TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6))
- Adverse Event Monitoring(TO (Baseline), T1 (Month 1), T2 (Month 2), T3 (Month 3), T4 (Month 4), T5 (Month 5), T6 (Month 6))
- Aberrant Behavior Checklist, Second Edition (ABC-2)(TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6))
研究者
Latha Soorya
Associate Professor | Department of Psychiatry & Behavioral Sciences Director | AARTS Center
Rush University Medical Center