Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Clinical Global Impressions - Improvement (CGI-I) Scale rating at School Year Follow Up
研究概览
简要总结
This study sought to evaluate an innovative post-acute continuation/transition planning treatment strategy that leveraged an in-person intensive treatment followed by online, videoconferencing-based "booster" sessions for youth with selective mutism (SM). Twenty children between the ages of 4 and 10 and their caregivers were scheduled to participate in an in-person intensive group behavioral treatment (IGBT) for SM and subsequently randomized to receive either (a) six, biweekly, hour-long, videoconferencing-delivered booster sessions or (b) no additional treatment for 12 weeks. Due to COVID-19-related physical distancing restrictions, the study team was unable to provide in-person services. Thus, the clinical trial was converted to an open-trial design focused on evaluating remote treatment options (i.e., remotely delivered caregiver training sessions and/or a remotely delivered IGBT) for these families. All families retained in the study have or will participate(d) in assessments at the following time points: Intake (i.e., 4-5 months prior to the remote IGBT); Baseline (i.e., 1 month prior to the IGBT), Post-IGBT (i.e., 2 weeks following the IGBT), and School Year Follow Up (i.e., 16 weeks following the IGBT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
"Independent evaluators" assigned to assess outcomes at Post-IGBT and School Year Follow-Up time points will be unfamiliar with families' progress during the IGBT, as well as masked to treatment participation (i.e., whether or not families participated in the remote IGBT).
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child between the ages of 4-10 years, and his or her caregiver(s)
- •Child meets DSM-5 criteria for selective mutism diagnosis
- •Child speaks English fluently
排除标准
- •Child is identified as having any psychiatric condition significantly more impairing than selective mutism that requires alternate treatment
- •The child is nonverbal with all caregivers
结局指标
主要结局
Clinical Global Impressions - Improvement (CGI-I) Scale rating at School Year Follow Up
时间窗: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
The CGI-I Scale (Guy \& Bonato, 1970) is a widely used global improvement measure; improvement is rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Independent evaluators masked to family participation/progress during the intensive group behavioral treatment (IGBT) and the post-acute strategy will complete the CGI-I rating. "Treatment Response" is defined as an independent evaluator rated CGI-I rating of 1 or 2 (ratings \>/= 3 represent "Treatment Nonresponse").
Clinical Global Impressions - Improvement (CGI-I) Scale rating at Post-IGBT
时间窗: Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
The CGI-I Scale (Guy \& Bonato, 1970) is a widely used global improvement measure; improvement is rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Independent evaluators masked to family participation/progress during the intensive group behavioral treatment (IGBT) will complete the CGI-I rating. "Treatment Response" is defined as an independent evaluator rated CGI-I rating of 1 or 2 (ratings \>/= 3 represent "Treatment Nonresponse").
次要结局
- Change from Baseline in Selective Mutism Questionnaire (SMQ) scores at School Year Follow Up(16-18 weeks after the Intensive Group Behavioral Treatment (IGBT))
- Change from Baseline in School Speech Questionnaire (SSQ) scores at School Year Follow Up(16-18 weeks after the Intensive Group Behavioral Treatment (IGBT))
- Change from Baseline in Children's Global Assessment Scale (CGAS) rating at Post-IGBT(Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT))
- Change from Baseline in Children's Global Assessment Scale (CGAS) rating at School Year Follow Up(16-18 weeks after the Intensive Group Behavioral Treatment (IGBT))
- Change from Baseline in Selective Mutism Questionnaire (SMQ) scores at Post-IGBT(Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT))
- Change from Baseline in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at Post-IGBT(Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT))
- Change from Baseline in Impairment Rating Scale - Parent Version (IRS-P) at School Year Follow Up(16-18 weeks after the Intensive Group Behavioral Treatment (IGBT))
- Change from Post-IGBT in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at School Year Follow Up(16-18 weeks after the Intensive Group Behavioral Treatment (IGBT))
- Change from Post-IGBT in Children's Global Assessment Scale (CGAS) rating at School Year Follow Up(16-18 weeks after the Intensive Group Behavioral Treatment (IGBT))
- Change from Baseline in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at School Year Follow Up(16-18 weeks after the Intensive Group Behavioral Treatment (IGBT))
- Change from Post-IGBT in Selective Mutism Questionnaire (SMQ) scores at School Year Follow Up(16-18 weeks after the Intensive Group Behavioral Treatment (IGBT))
- Change from Baseline in Impairment Rating Scale - Teacher Version (IRS-T) at School Year Follow Up(16-18 weeks after the Intensive Group Behavioral Treatment (IGBT))