Tele Toy Talk: Telehealth Language Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in Brief Observation of Social Communication Change (BOSCC) scores
研究概览
简要总结
The main goal of this intervention is to increase caregivers' use of interactive play and communication strategies to improve the child's early sentence development using telemedicine and video-based feedback.
详细描述
Record was updated 11/2/2021 to include more detailed information about outcome measure time points. Specifically, secondary outcome measures will be collected more frequently over the course of the study (i.e., at baseline [before starting intervention], immediate follow-up [week 12], and long-term follow-up [3 months after intervention] assessments). No changes were made to outcome measures or how they are operationalized.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of autism spectrum disorder (ASD) and/or communication disorder
- •Child speaks at least 50 single words or uses emerging word combinations
- •Caregivers have Internet availability from their home
排除标准
- •Child speaks using complex sentences
- •Child is not within 2 to 4 years of age at time of enrollment
结局指标
主要结局
Change in Brief Observation of Social Communication Change (BOSCC) scores
时间窗: Baseline (before starting intervention); Week 4; Week 8; Week 12
Child's scores on the Brief Observation of Social Communication Change (BOSCC) at baseline, intervention midpoint, and post-evaluation. BOSCC scores are not linear. Each item is rated on a 6-point scale from 0 (abnormality is not present) to 5 (abnormality is present and significantly impairs functioning).
Change in number of unique combinations of subjects and verbs - caregiver
时间窗: Baseline (Before starting intervention); Week 4; Week 8; Week 12
Number of unique combinations of subjects and verbs used by the caregiver at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.
Change in child mean length of utterance
时间窗: Baseline (before starting intervention); Week 4; Week 8; Week 12
Mean length of utterance used by child at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.
Change in number of unique combinations of subjects and verbs - child
时间窗: Baseline (Before starting intervention); Week 4; Week 8; Week 12
Number of unique combinations of subjects and verbs used by the child at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.
Change in caregiver mean length of utterance
时间窗: Baseline (before starting intervention); Week 4; Week 8; Week 12
Mean length of utterance used by caregiver at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.
次要结局
- Change in scores on the Observation of Spontaneous Expressive Language (OSEL) - baseline(Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention))
- Change in scores on the Vineland-3(Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention))