Comparative Efficacy of a Self-directed and Therapist-assisted Telehealth Parent Training Intervention for Children With ASD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Project ImPACT Intervention Fidelity Checklist
研究概览
简要总结
The specific objectives of this project are to conduct a randomized control trial to examine the effect of a novel, telehealth parent training intervention for children with autism spectrum disorder (ASD), ImPACT Online, on parent and child outcomes. The investigators will compare the benefits of the self-directed and therapist-assisted delivery formats, and examine moderators and mediators of treatment outcomes. The investigators anticipate that both the self-directed and therapist-assisted models of ImPACT Online will be effective methods for teaching parents to use evidence-based intervention strategies and for increasing parent self-efficacy compared to a web-based information control group. Participants will be randomly assigned to one of three groups. One-third of participants will be in the therapist-assisted group; one-third will be in the self-directed group; and one-third will be in a web-based information control group.
详细描述
Autism spectrum disorder (ASD) is a chronic and pervasive neurodevelopmental disorder characterized by deficits in social communication and the presence of restricted and repetitive behaviors. Individuals with ASD often require intensive and comprehensive intervention across the life span. There has been a dramatic increase in the number of individuals with this diagnosis over the last two decades, with current prevalence rates as high as 1 in 68. However, there has not been corresponding growth in the availability of evidence-based intervention services, contributing to high levels of unmet service needs for individuals with ASD and their families. The vast majority of families of children with ASD report receiving substantially fewer hours of services than recommended by the National Research Council. Furthermore, levels of unmet service needs are even higher for families residing in rural and medically underserved communities. Thus, systematic research focused on developing and improving strategies for dissemination and implementation of evidence-based ASD services is a high priority, particularly for chronically underserved communities.
Parent training programs are one cost-effective and ecologically valid way to increase access to evidence-based ASD intervention. Training parents to provide intervention themselves can increase the number of intervention hours a child receives and improve child outcomes. A number of studies have demonstrated that parents can learn to use evidence-based intervention strategies with a high degree of fidelity and their children experience gains in language and social communication development, decreases in disruptive behavior, and greater generalization and maintenance of child skill. These benefits are recognized by parents, who report parent training to be the most effective practice for promoting their child's overall development. Parent training also improves family quality of life by increasing parent self-efficacy and reducing parenting stress, which is particularly important given the high rate of stress and depression found in parents of children with ASD.
Despite these benefits, there continue to be barriers to the dissemination of training to parents. Formal parent training programs are rare in community-based early intervention settings for young children with ASD. For example, in a recent North Carolina survey, only 8% of parents of children with ASD under 4 reported receiving parent training. Barriers to the provision of parent training include a shortage of trained professionals, lengthy waitlists, limited financial resources and transportation, lack of child care, geographic isolation, and time limitations. These barriers may be even more pronounced for families who live in rural areas, for whom long distances, poor roads, and climatic barriers limit the ability of parents to receive services. Thus, it is essential to consider the adaptation of evidence-based parent training programs to non-traditional service delivery models to increase access to services.
Telehealth, or the provision of health services and information through the Internet and related technologies, has the potential to replace or, at the very least, augment traditional service models to increase access to evidence-based services. Users of telehealth programs are able to interact directly with instructional content through video, animation, and active learning tasks, as well as with other individuals, including expert clinicians, via email and teleconferencing systems. The number of individuals with access to internet-based technologies has grown considerably in recent years (File T, 2013), and it is now estimated that 75% of U.S. households have a home computer with high-speed internet, and nearly 87% of adults are able to access the internet from home, work, or elsewhere. Telehealth services are becoming increasingly common with over 3,000 U.S. sites using distance-based service delivery models to provide patient care.
Telehealth programs can reduce patient and provider costs and increase provider system coverage relative to traditional in-person service delivery models. Such programs have been shown to greatly improve care for patients with chronic diseases, such as diabetes, heart disease, and asthma, and increase access to evidence-based health promotion (i.e., smoking cessation, dietary change, physical activity), psychological (i.e., CBT for depression and anxiety), and parenting interventions. Patients are often very satisfied with the care they receive through telehealth services, and efficacy studies have found moderate to large effects of telehealth interventions on participant knowledge and behavior change. Further, several recent meta-analyses have found that CBT delivered via telehealth is as effective as traditional therapist-delivered intervention. Taken together, these data suggest that telehealth may serve as a promising alternative service delivery model to increase the dissemination of ASD parent training programs.
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
- 18 Months 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for child participants:
- •a DSM-V-informed clinical diagnosis of Autism Spectrum Disorder based on the Autism Diagnostic Observation Schedule (ADOS)
排除标准
- •for child participants:
- •history of significant brain injury, known neurological or genetic condition
- •significant sensory or motor impairment
- •major medical problems
- •Inclusion Criteria for parent participants:
- •primary caregiver of child participant
- •Proficient in English
- •Exclusion Criteria for parent participants:
- •under 18 years
研究组 & 干预措施
Self-Directed Group
Participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
干预措施: ImPACT Online (Behavioral)
Therapist-Assisted Group
Participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. Participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
干预措施: ImPACT Online (Behavioral)
Web-Based Information Control Group
Participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for participant maturation as well as the potentially confounding effect of having access to autism-related information via the internet.
结局指标
主要结局
Project ImPACT Intervention Fidelity Checklist
时间窗: Follow up (9 months)
Parents' use of the intervention strategies with their child is measured during a parent-child interaction in the home using the Project ImPACT Intervention Fidelity Checklist (Ingersoll \& Dvortcsak, 2019). Parents are asked to (1) play with their child for 10 minutes with a standard set of toys; and (2) have a small snack or meal with their child for 10 minutes. Parents are instructed to interact with their child as they typically would during both activities. Coders rated the parents' use of each of the five Project ImPACT intervention strategies on a scale of 1 ("does not implement the strategy, or almost all attempts to use the strategy are incorrect.") to 5 ("implements the strategy effectively throughout the session"). Scores for each strategy were averaged to form an overall fidelity rating for each activity. Fidelity ratings for each activity were averaged to form the parent fidelity variable.
Parent Sense of Competence (PSOC)
时间窗: Follow up (9 months)
The PSOC measures the extent to which parents believe they have the skills and knowledge needed to be good parents (efficacy) and their perceptions regarding the value of parenthood (satisfaction). Parents rated 17 items from 1 ("Strongly disagree") to 6 ("Strongly agree"). Items are summed, scores can range from 17 to 102, with higher scores indicative of higher parenting self-efficacy.
Weighted Frequency of Intentional Communication
时间窗: Post-treatment (6 months)
Children's use of intentional communication is scored from a parent-child interaction during play and snack using a modified version of the Weighted Frequency of Intentional Communication (WFIC) coding scheme (Yoder et al., 2021a), which quantifies the maturity of the form and frequency of intentional communication in young children with social communication delays. Coders transcribed and coded all non-imitated communicative utterances, including gestures, contingent vocalizations, single-words, simple phrases, and sentences. Each utterance was weighted (1-4) based on its complexity. Utterances are summed to produce a weighted frequency. Weighted frequency was were converted to a rate per minute by dividing the score by the length of the video. Values were log transformed to improve normality of distribution. Values ranged from -1.30 to 1.57 with higher values indicated higher weighted frequency of intentional communication. Means are adjusted for their T1 measure.
Child Expressive Language Ability
时间窗: Follow up (9 months)
Equally weighted composite score of child expressive language ability derived from MacArthur Bates Communicative Development Inventory (MB-CDI), Mullen Scales of Early Learning (MSEL) Expressive Language raw score, and Vineland Adaptive Behavior Scales (VABS) Expressive Language raw score. Measures were z-score transformed and averaged. Z-score of 0 represents mean for the participants. Positive z-score represent a better outcome.
Project ImPACT Intervention Fidelity Checklist
时间窗: Post-treatment (6 months)
Parents' use of the intervention strategies with their child is measured during a parent-child interaction in the home using the Project ImPACT Intervention Fidelity Checklist (Ingersoll \& Dvortcsak, 2019). Parents are asked to (1) play with their child for 10 minutes with a standard set of toys; and (2) have a small snack or meal with their child for 10 minutes. Parents are instructed to interact with their child as they typically would during both activities. Coders rated the parents' use of each of the five Project ImPACT intervention strategies on a scale of 1 ("does not implement the strategy, or almost all attempts to use the strategy are incorrect.") to 5 ("implements the strategy effectively throughout the session"). Scores for each strategy were averaged to form an overall fidelity rating for each activity. Fidelity ratings for each activity were averaged to form the parent fidelity variable.
Parent Sense of Competence (PSOC)
时间窗: Post-Treatment (6 months)
The PSOC measures the extent to which parents believe they have the skills and knowledge needed to be good parents (efficacy) and their perceptions regarding the value of parenthood (satisfaction). Parents rated 17 items from 1 ("Strongly disagree") to 6 ("Strongly agree"). Items are summed, with higher scores indicative of higher parenting self-efficacy. Scores can range from 17 to 102, with higher scores indicative of greater self-efficacy
次要结局
- Family Impact Questionnaire(Post-Treatment (6 months))
- Parenting Stress Index-Short Form(Post-Treatment (6 months))
- Mullen Scales of Early Learning(Follow up (9 months))
- MacArthur-Bates Communicative Development Inventory(Follow up (9 Months))
- Vineland Adaptive Behavior Scales, 2nd Edition(Follow up (9 Months))
研究者
Brooke Ingersoll
Associate Professor
Michigan State University
