The More Than Words® Parent-Delivered Program for Autistic Children and Those with Social Communication Challenges: a Single Arm Pragmatic Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Recruitment capability
研究概览
简要总结
The Hanen Centre®'s More Than Words® (MTW) program is a globally used, parent coaching intervention delivered by speech-language pathologists (SLPs) to parents of children with social communication challenges, including those who have a confirmed or suspected diagnosis of autism. The training program is designed to provide parents with the tools, strategies, and support they need to help their children reach their full communication and social interaction potential. In this study, children and parents enrolled in the MTW program as a part of their current standard of care will be recruited by their SLPs from their community sites of the publicly-funded Ontario Preschool Speech and Language Program. The primary aim is to evaluate the feasibility and acceptability of study procedures in recruitment and data collection involving parents and children receiving MTW in the community. The investigators will also examine changes in child communication, parent-child social interactions, parent confidence, and parent use of social communication strategies prior to and following participation in the program. Findings from this study will inform the optimal design of a future pragmatic randomized control trial to examine the effectiveness of the MTW program for preschool children and their caregivers.
详细描述
Background
Pediatric speech-language pathologists (SLPs) provide early intervention services that focus on supporting children to engage, interact, and communicate with the people around them in meaningful contexts. For young children, their parents are often their primary communication partners. Parent coaching interventions are commonly used by SLPs to support social communication development in young autistic children. Parent coaching interventions allow clinicians to capitalize on parents' expert knowledge of their child. Additionally, these interventions increase the potential for children to generalize skills learned in sessions to their daily life, thus increasing treatment dosage without increasing the cost. Furthermore, by reducing the frequency of direct contact hours with the therapist, public systems can distribute these interventions with fewer resources and to more parents.
One parent coaching intervention commonly used by SLPs is More Than Words® - The Hanen Program® for Parents of Autistic Children or Children Who May Benefit from Social Communication Support (MTW). In fact, a recent survey identified MTW as the preschool autism intervention program most widely used (61%) by SLPs in Ontario, Canada. The two existing RCTs on MTW involved university-based program delivery and report mixed findings that included positive effects in parents' responsiveness and aspects of social communication for some children. Non-randomized observational studies of the MTW program reported improved parent responsiveness, self-efficacy, and interaction style; and improved child language and social communication skills post-program. When asked about perceived outcomes, parents from community-delivered MTW programs highlighted the new strategies they learned, their child's growth in functional communication skills, overall improvement in their relationship with their child, and the social and professional support network they gained. Studies of parents' experiences participating in MTW suggests they value the program and the opportunity to connect with other parents, but seek improvements in navigating program content, the numerous forms associated with participation, parent-to-parent discussion, and the amount of individualized time with the SLP. Although these results are promising, as is the case for parent-delivered interventions more broadly, community-based RCTs of the MTW program are lacking, and little evidence exists for the mediators and moderators of effective MTW delivery in real-world practice. Pragmatic RCTs are needed to build this understanding.
For a pragmatic RCT of the MTW program (and other parent coaching interventions) to be useful, it is critical to ensure that the methods used to evaluate treatment effects and mediators/ moderators are not only sound but also ecologically valid and feasible for use in the community practice contexts in which the study is to be conducted. Given that real-world practice can be highly variable and unpredictable in ways that are outside of the control of the researcher, large-scale RCTs can be at risk for implementation failure without careful attention at the methodological planning stages. One solution is to first conduct a pragmatic methodological feasibility trial to identify and develop mitigation plans for possible issues in recruitment, retention, data collection, and analysis. A second associated solution is to employ principles of integrated knowledge translation, that is, ensure that co-construction and collaboration between researchers and community partners begins right from the planning stages. This can ensure that outcome measures selected are ideal from both a reliability, validity, and sensitivity perspective and practical for clinicians and families to use during real-world program delivery. In sum, for a full-scale pragmatic RCT to be successful and for results to be meaningful to end users, foundational work is needed that focuses on (a) systematic co-development of a comprehensive evaluation protocol and (b) pilot testing of the acceptability and feasibility of the evaluation protocol within real-world community settings.
With an overarching objective to conduct pragmatic RCTs of the MTW program, the investigators first needed a comprehensive evaluation protocol of the MTW program as implemented in community practice that would be both feasible for clinicians and families and sensitive enough to measure treatment effects and moderators and mediators of child and family outcomes. Therefore, the investigators partnered with program developers and expert SLPs from The Hanen Centre to co-construct a logic (causal) model of the MTW program that links specific program objectives with evaluation tools (outputs, outcomes) and procedures. In brief, key areas integrated during development of the logic model and evaluation plan included: (a) theories and research guiding MTW program development, (b) outcome measures and treatment mediators and moderators identified in previous research, (c) expert SLP views on MTW objectives and outcomes, and mediators and moderators affecting treatment responses, and (d) organizational structures, barriers, and facilitators for SLPs delivering the program. The result of this co-construction process was a logic model of the MTW program and an associated evaluation protocol with proposed outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Research team members coding the parent-child interaction videos using to the Joint Engagement Rating Inventory are masked as to the pre/post-treatment order of the videos.
入排标准
- 年龄范围
- — 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Children
- •diagnosed with autism, suspected of having autism, or identified as having social communication challenges
- •≤ 47 months of age
- •demonstrates delays in social communication and play skills according to their speech-language pathologist's clinical assessment
- •available to attend the 13-week MTW program
- •comfortable communicating in English (the language of MTW program delivery in this study)
- •C. Speech-language pathologists
- •previously delivered at least three More Than Words programs prior to the study
- •planning to offer a 13-week program in English between January 2022 and April 2023 as a part of the Ontario Preschool Speech and Language Program
- •willing and able to support planned data collection activities
排除标准
- 未提供
研究组 & 干预措施
Feasibility testing
Participants in this feasibility trial include parent-child pairs who (a) are enrolled in the More Than Words (MTW) program with their community SLP as a part of standard care and (b) have agreed to participate in the feasibility research trial while receiving the program, as well as the community SLPs delivering the program to these families. We previously developed a comprehensive evaluation protocol of the MTW program as implemented in community practice that would be both feasible for clinicians and families and sensitive enough to measure treatment effects and moderators/mediators of child and family outcomes. The purpose of this feasibility trial is to assess: (a) recruitment capability, (b) feasibility, acceptability, and practicality of data collection and analysis procedures, and (c) preliminary effectiveness based on the selected outcome measures.
干预措施: More Than Words® (Behavioral)
结局指标
主要结局
Recruitment capability
时间窗: From up to 3 months to 1 week before families begin a More Than Word program being offered in their community
Number of speech-language pathologists and parents agreeing to participate as a part of a 13-week program being offered in their community as a part of standard care. Enrollment is rolling throughout the study period.
Reasons for nonenrollment
时间窗: Reasons are collected from speech-language pathologists either within 3 months before or 3 months after they finish delivering a More Than Words program in their community
Reasons for speech-language pathologists and parents declining participation
Overall rate of study measure completion
时间窗: The investigtors calculate the overall rate of study measure completion within 1 year after the study closes
This is a feasibility outcome measure to test the success of study data collection. As a part of the study, participants are asked to complete study measures (see outcome measures #6-13 below) before, during, and/or after the More Than Words program is delivered as a part of standard care in their community setting. This completion rate measure is a tally of the total number of study measures that are successfully collected out of the total number of study measures that expected to be complete and submitted by participants (in other words, the overall number of missing measures). As this is a pragmatic feasibility trial, the community speech-language pathologists and caregivers complete/collect the measures, not the investigators.
Change in prelinguistic and early communication skills
时间窗: Within 2 weeks before and within 2 weeks after the 13-week More Than Words program
The Communication and Symbolic Behavior Scales - Developmental Profile Caregiver Questionnaire contains 41 multiple-choice items rated by parents about a range of their child's prelinguistic skills. Raw scores are collected for overall early communication skills (Total score) as well as Social, Speech, and Symbolic Communication (3 composite scores)
Time required for the investigators to code videos
时间窗: The SLP uploads the video recordings within 1 month of the families finishing the More Than Words program and the investigators code them within 1 year of study closure
This is a feasibility outcome measure to evaluate how long it takes (in minutes) for the investigators to code videos of parent-child interactions (see outcome measures #9-10 below). The videos are recorded during community-based delivery of the More Than Words program by speech-language pathologists. The parent and child participate in a recorded play interactions as a part of standard program delivery at their pre-program consultation session (week 2) and the final individual videofeedback session (week 12). The investigators will code the video interactions after the families have finished completing the program.
Perceived feasibility and acceptability of study methods
时间窗: Within 3 months of the families finishing the More Than Words program
Participating speech-language pathologists' perceptions on the barriers and enablers to the study (recruitment and data collection, practicality and useability of outcome measures and procedures, suggested design changes for future RCTs) based on qualitative content analysis of field notes from semi-structured interviews
Change in child's communicative participation
时间窗: Within 2 weeks before and within 2 weeks after the 13-week More Than Words program
The Focus on the Outcomes of Communication Under Six-34 measures real-world changes in children's communicative participation in response to speech-language intervention. It includes 23 items on the child's capacity for communication and 11 items on the child's ability to engage independently, both rated by parents on a 7-point Likert scale. The total raw score (ranging between 34-238 points) is collected. In addition, change in total raw score from before to after intervention is classified according to the following clinical benchmarks: a change of 11 points or more is considered a meaningful clinical change, 7-10 is possibly a meaningful clinical change, and 6 or less is not likely a meaningful clinical change.
Child's social communication stage and skills
时间窗: During the pre-program consultation session (week 2) of the More Than Words program and again within 2 weeks after the program ends.
The Social Communication Checklist is developed by the Hanen Centre and complete by the speech-language pathologist delivering the More Than Words program in collaboration with parents to identify which of four stages best describe the child's communication skills: Own Agenda, Requester, Early Communicator, and Partner. The number of checkmarks at each stage is tallied, with more checkmarks at higher stages indicative of better outcomes. The number of skills children gain at each stage from before to after the program will be counted.
Change in severity of child's social communication challenges
时间窗: Videos are recorded during the Pre-Program Consultation session (week 2) and the third Video Feedback Session (week 12)
Coded by the investigators using parent-child interaction videos that are recorded by the speech-language pathologist as a part of the More Than Words program. The Clinical Global Impressions coding pre-program assesses how impacted the child appears to be by social communication challenges on a 7-point Severity scale (1-normal, 2-borderline, and 3-mildly, 4-moderately, 5-markedly, 6-severely, 7-extremely impacted). Coding post-program assesses changes in the severity of these social communication challenges relative to the pre-program video on a 7-point Improvement scale (1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, 7-very much worse), with higher Improvement ratings meaning worse outcomes. Investigators code the videos within one year of families finishing their More Than Words program
Change in child and parent social engagement and interaction
时间窗: Videos are recorded during the Pre-Program Consultation session (week 2) and the third Video Feedback Session (week 12)
Coded by the investigators using parent-child interaction videos that are recorded by the speech-language pathologist as a part of the More Than Words program. The Joint Engagement Rating Inventory measures social engagement behaviors targeted by the More Than Words program. This includes five child (Initiation, Responsiveness, Expressive language, Behaviour patterns, Affect), four parent (Scaffolding, Symbol highlighting, Following in, Affect), and two parent-child interaction (Fluency \& Connectedness, Routines \& Rituals) behaviors. Each behavior item is scored on a 7-point rating scale (ranging from being 1-minimally to 7-highly present, with higher scores meaning better outcomes). The investigators code the videos within one year after families finish their More Than Words program
Change in parent self-efficacy
时间窗: During the begining of the first group session (week 3) and at the end of the final group session (week 13) of the More Than Words program.
In an online survey form, two self-efficacy questions ask parents to rate their confidence in helping their child to communicate and to develop their play skills, respectively, on a 7-point Likert scale (from 1-strongly agree to 7-strongly disagree, with higher scores meaning a worse outcome).
Change in parent strategy use
时间窗: During the begining of the first group session (week 3) and at the end of the final group session (week 13) of the More Than Words program.
In an online survey form, the two open-ended questions asked parents to list strategies or techniques they use to support their child's communication and play skills, respectively. Qualitative content analysis is used by the researchers to summarize and identify themes in the responses.
Perceived program effectiveness according to parents
时间窗: During the final group session (week 13) of the More Than Words program
In an online survey form, parents rate statements and answer questions about whether, and to what extent, their child benefitted from the MTW program, they found the program to be helpful, and they changed how they interact and communicate with their child
次要结局
未报告次要终点
研究者
Janis Oram
Professor
Western University, Canada