ACTRN12619000483156招募中未知
A randomised controlled trial (RCT) investigating the efficacy of the group-based delivery of a parent-mediated intervention for mitigating autistic symptom severity among infants with social and communication delay
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 7 Months 至 o limit（—）
- 性别
- All
入选标准
- •Infants will be offered participation in this trial if they:
- •(a) Are between 7 months, 0 days and 14 months, 31 days of age (corrected for those infants born <37 weeks gestation);
- •(b) Endorsement of three or more of the ‘key items’ on the 8-month (for infants 7mo, 0 days – 10mo, 31 days) or 12-month (for infants 11mo, 0 days – 14mo, 31 days) SACS-R.
- •(c) The primary caregiver involved in the trial speaks sufficient English to: (i) understand the requirements of the study, and (ii) is deemed to be able to participate fully in the therapy sessions.
排除标准
- •Participants will be excluded from the study if they meet any of the following characteristics:
- •(a) The infant has a diagnosed comorbidity known to affect neurological and developmental abilities (e.g., preterm birth < 32 weeks, cerebral palsy, Down syndrome, Rett syndrome, other chromosomal abnormality, hearing/visual impairment), and/or
- •(b) The family does not intend to remain living in the Perth area for the next 12 months.
- •(c) Any active court proceedings or special care arrangements (e.g., children in care of the state or situations where there is not a consistent, long-term caregiver) that may impact on participation in the study
研究者
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