Improving Barriers to Care Access for Children With Autism and Related Needs Via Telehealth for Evaluation, Care Navigating, and Caregiver Coaching
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Brief Observation of Social Communication Change (BOSCC)
研究概览
简要总结
The objectives of the current project are to develop and implement training with community providers to evaluate a supplemental parent coaching intervention delivered via telehealth to improve child communication and behavioral outcomes, parental stress outcomes, and to investigate telehealth models to reach children in geographically dispersed or highly mobile locations and/or from military connected families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provider Inclusion Criteria:
- •Providers to participate who are in "lead" or supervising roles (e.g., clinical supervisors, lead therapists, level II/level I EIDBI providers),
- •Participating providers are encouraged to have a master's degree or higher, be level I, or serve as a level II provider with established experience (e.g.,supporting families who speak another language or be certified by a tribal government) however, this decision is up to the participating organization
- •Child/Caregiver Inclusion Criteria:
- •Child between ages 1 to 5
- •Waiting for either ASD diagnosis or intervention,
- •At least one caregiver (approved by the parent) willing to participate
- •Ability to complete approximately three, 30 min sessions over 12 weeks and to complete pre and post study measures
- •Child may not be currently receiving intensive (10 or more hours a week) or early intensive behavioral intervention (EIBI), but may be on a waitlist for these services, and can be enrolled in Early Childhood Special Education services Parts B and C, and auxiliary services such as speech, physical, and occupational therapy.
- •Child/Caregiver
排除标准
- •Children will be assessed through an eligibility screener to determine if they have challenging behavior that may be dangerous. Families will be assessed to determine eligibility through a screener, several of the questions will be aimed to identify challenging behavior severity, behaviors including topographies such as eye gouging and other forms of severe self-injury or aggression that cause significant or dangerous tissue damage (e.g., such as breaking the skin, drawing blood, open wounds that could be infected, or leaves a contusion, visits to an emergency room or hospitalization due to challenging behavior) to a child or others may be considered too severe to participate in the study.
- •Families will also be asked if a participating caregiver is pregnant, if they indicate yes, they will still be eligible to participate with their child, but certain activities may be skipped if the child engages in challenging behavior, such as aggressive behavior.
研究组 & 干预措施
Naturalistic Developmental Behavioral Intervention (NDBI)
NDBIs are embedded with developmental principles and practices with an emphasis placed on naturalistic intervention elements (e.g., targeting skills within a developmentally appropriate sequence). In addition to adhering to recommended early intervention practices involving naturalized, routines-based, and family-centered interventions, NDBIs may be easier for parents to implement and may promote child skill acquisition in a natural manner and therefore promote generalization and maintenance of skills.
干预措施: NDBI (Other)
Waitlist
Families randomized to this condition have a 12-week waiting period, after which point they rollover to the NDBI intervention.
结局指标
主要结局
Change in Brief Observation of Social Communication Change (BOSCC)
时间窗: Week 12
15 items, each scored from 0 (abnormality is not present) to 5 (abnormality is present and significantly impairs functioning. Minimum score = 0 Maximum score = 75 Higher score = higher impact on functioning (worse outcome)
Change in Repetitive Behavior Scale for Early Childhood
时间窗: Week 12
4 items across 4 subscales; scored from 0 (bx does not occur) to 4 (bx occurs many times per day) Minimum score = 0 Maximum score = 136 Higher score = more frequent/severe repetitive behaviors (worse outcome)
Change in Autism Impact Measure
时间窗: Week 12
41 items Individual subdomains (frequency and intensity) Minimum score: 41 Maximum score: 205 Higher score = poorer outcomes Total score: Minimum score: 82 Maximum score: 410 Higher score = poorer outcomes
Change in Autism Family Experience Questionnaire
时间窗: Week 12
48 items, each scored on a 1-5 scale Minimum score = 48 Maximum score = 240 Higher score = poor outcomes
Change in Measure of NDBI Strategy Implementation-Caregiver Change
时间窗: Week 12
21 items on a 1-5 scale Minimum score: 21 Maximum score: 105 Lower score = poorer strategy implementation
Measure Fidelity
时间窗: Week 12
Completed weekly until community provider participants reach 80% fidelity. The form consists of a 15 point questionnaire completed by the trainer, which was created by the study team. The score for each item = NA, 0, 1 or 2. Max fidelity score 24-30 (3 items can be scored as NA meaning not applicable or no opportunity.)
Provider Knowledge Gain
时间窗: Week 12
Administered before and after synchronous training session conducted by study intervention team to measure community provider participant's knowledge of the training topics. The measure consists of 8 multiple choice questions and 15 short answer questions. Completion of the questionnaires informs provider baseline knowledge as well as future modifications to the training curriculum.
次要结局
未报告次要终点