The More Than Words® Program for Parents of Young Children With Social Communication Challenges: A Pilot Pragmatic Randomized Waitlist-Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Changes from baseline in Child Communicative Participation at post-program and follow-up
研究概览
简要总结
"More Than Words® - The Hanen Program® for Parents of Autistic Children or Children Who May Benefit from Social Communication Support" is a family-focused intervention program delivered by a speech-language pathologist (SLP). The goal of More Than Words is to empower parents to be the main facilitator of their child's social communication development, which increases the child's opportunities to develop social communication skills in everyday situations. It is one of the programs offered to families who receive services from Ontario's Preschool Speech and Language program, although some regions are not able to offer it at all or are only able to offer a shortened version of the program. The Hanen Centre recently made updates to the More Than Words program to allow it to be delivered virtually (online) and to align with the latest evidence.
Past research has found some evidence that the More Than Words program is effective, but knowledge is needed about the latest version of the program, including how effective it is when delivered online. It is important to understand who this program works best for and why. The purpose of the current study, called a pilot study, is to test a study plan that could be used in a future large study to answer these questions.
In this pilot study, the investigators will test procedures for comparing the outcomes of families who receive the More Than Words program to families who have not yet received it. Additionally, procedures for understanding varying responses to treatment will be tested. The study aims to determine whether the methods used for recruiting families, delivering the program, and monitoring progress are practical and function as expected in preparation for the future large-scale study.
详细描述
Background Pediatric speech-language pathologists (SLPs) report that a substantial proportion of their caseloads now include children with diagnosed or suspected autism. This aligns with persistent increases in autism diagnoses worldwide and underscores the importance of effective, feasible, and resource-efficient support services. For children with diagnosed autism, or children with social communication challenges who may be waiting for diagnostic assessments, identifying effective services targeting language and social communication is particularly important because development of these skills is among the most important contributors to long-term outcomes in autistic children. Furthermore, supporting social communication aligns with parents' treatment priorities for their autistic children.
SLPs provide early support services that focus on promoting engagement and communication within meaningful contexts. For young children, their parents are often their primary communication partners. Therefore, 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. 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 optimize resource use and make these interventions accessible to a greater number of parents.
The past decade has seen an increase in the number of randomized control trials (RCTs) examining the efficacy of parent-delivered early interventions for autistic children; however, most were conducted in specialized research clinics that often do not reflect how treatment is offered by community SLPs. This can negatively impact the generalizability of the findings to real-world clinical practice. While explanatory trials determine the efficacy of an intervention (in a highly controlled setting), pragmatic trials determine the effectiveness of an intervention in a real-world context, that is, everyday clinical practice. Pragmatic RCTs embrace the complexity, unpredictability, and inconsistency inherent in routine clinical practice by including diverse patient populations and allowing flexibility and variability in how the intervention is delivered. Additionally, few clinical trials have included examination of for whom the intervention works (moderators of treatment outcome), why the intervention works (mediators of treatment outcomes), or how implementation processes could have impacted treatment effects. This leaves clinicians with limited information to effectively individualize and refine interventions to fit child, family, and system needs.
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, (b) testing of the acceptability and feasibility of the evaluation protocol within real-world community settings, and subsequently, (c) pilot testing of a pragmatic RCT protocol.
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)
盲法说明
Because we are comparing receipt of a behavioural intervention to no treatment (waitlist for the treatment), masking of the participants and care providers is not possible. Outcome assessors conducting data entry and coding will be masked. Masking will be accomplished using de-identified participant ID numbers that do not identify group assignment and randomize the actual order in which repeated measures were collected .
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
- •The child is under 48 months of age at the time of study enrolment.
- •The child has delays in social communication and play skills according to the clinical assessment of the child's community SLP.
- •The parent (or other primary caregiver) has a smart phone, tablet, or computer with webcam and internet access to attend the virtual MTW sessions and complete study measures
- •The parent is available to attend the 13-week virtual MTW program (which includes 9 online group sessions on Saturday mornings or Monday evenings).
- •The parent is comfortable communicating and filling out forms in English.
排除标准
- •Failure to meet the inclusion criteria outlined above.
研究组 & 干预措施
Virtual MTW Treatment Group (TG)
The TG will receive the MTW program which consists of (a) an orientation session, (b) a pre-program consultation appointment, (c) eight 2½ hour group training sessions (8-10 parents/group), and (d) three individual video feedback sessions. At the orientation session, the SLP provides an overview of the program, and provides the parent with two assessment forms to complete (i.e., parent report measures of their child's social communication and communicative participation). At the pre-program consultation, the SLP conducts an informal assessment of the child's communication and records a video of the parent-child interaction. Parents and SLPs co-develop communication goals based on the child's social communication needs and ability. During group training sessions, parents learn support strategies to target goals (e.g., joining a child's idea in play, rather than directing the play; using gestures and animated facial expressions to get the child's attention).
干预措施: The Hanen Centre's More Than Words® program (Behavioral)
Waitlist Control Group (WCG)
The WCG will be in a waiting period for three months, after which they will receive the Hanen More Than Words® program. However, they can still access other services in their community to support their child during their waiting period.
结局指标
主要结局
Changes from baseline in Child Communicative Participation at post-program and follow-up
时间窗: Within 2 weeks before the waitlist period (control group only), 2 weeks before program start, 2 weeks after program end, 13-15 weeks after program end
The FOCUS-34 is a reliable and validated criterion-referenced measure of real-world changes in children's communicative participation in response to speech-language intervention. The FOCUS-34 includes 34 items based on the Activities and Participation components of the ICF. It includes 23 items focused on the child's capacity for communication and 11 items on the child's ability to engage independently, both of which parents rate on a 7-point Likert scale. The total score on the FOCUS-34 ranges from 34-238 points, although the primary clinical outcome is the pre-post-program change scores. A change score 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. The FOCUS-34 is used in the Ontario PSL as a provincial outcome monitoring tool and thus is part of the existing standard of care for participants in this study.
Changes from baseline in global social communication challenges at post-program and follow-up
时间窗: Within 2 weeks before the waitlist period (control group only), 2 weeks before program start, 2 weeks after program end, 13-15 weeks after program end
The Clinical Global Impression (CGI) is a tool designed to quickly and sensitively monitor patient progress within clinical trials and has been adopted for the purpose of evaluating social communication behaviors following delivery of brief clinical interventions. The CGI-Severity will be coded at each timepoint in response to the prompt, "How impacted is the participant by social communication challenges at this time?" using a 7-point severity scale (1-normal, 2-borderline, and 3-mildly, 4-moderately, 5-markedly, 6-severely, 7-extremely impacted). Post-program, CGS-Improvement will be coded to assess changes in social communication challenges relative to pre-program on a 7-point 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.
Changes from baseline in joint engagement at post-program and follow-up
时间窗: Within 2 weeks before the waitlist period (control group only), 2 weeks before program start, 2 weeks after program end, 13-15 weeks after program end
The Joint Engagement Rating Inventory (JERI) is an observational measure designed to capture various features of joint engagement that occur between young children and their parents. The 2020 version of the JERI has 32 items, but as recommended in the manual, the investigators will use a subset of social engagement behaviors aligned with the specific research questions, namely, 11 items aligned with skills targeted by the MTW program. This includes five child behavioural outcomes (initiation of communication, responsiveness to partner's communication, expressive language level and use, quality of behaviour patterns, affect), four parent behavioural outcomes (affect, following in on the child's focus, symbol highlighting, scaffolding) and two dyadic interaction items (fluency and connectedness, routines and rituals). 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).
Changes from baseline in parent evaluation of self-efficacy and services at post-program and follow-up
时间窗: Within 2 weeks before the waitlist period (control group only), 2 weeks before program start, 2 weeks after program end, 13-15 weeks after program end
The Parent Self-Efficacy and Services Evaluation survey incorporates two self-efficacy questions from the Early Intervention Parenting Self-Efficacy Scale: (a) "I feel confident that I can help my child to communicate their thoughts and ideas" and (b) "I feel confident that I can help my child develop their play skills". Each question will be rated on a 7-point Likert scale (from 1-strongly agree to 7-strongly disagree, with higher scores meaning a worse outcome). The remaining questions ask parents to report on and evaluate the perceived effectiveness of any services or developmental supported received over the last 3 months (including the MTW program after they receive it).
Changes from baseline in child prelinguistic skills at post-program and follow-up
时间窗: Within 2 weeks before the waitlist period (control group only), 2 weeks before program start, 2 weeks after program end, 13-15 weeks after program end
The Communication and Symbolic Behavior Scales - Developmental Profile Caregiver Questionnaire (CSBS-DP CQ) contains 41 multiple-choice items that assess seven prelinguistic skills: emotion and eye gaze, communication (rate and communicative function), gestures, sounds, words, understanding, and object use (symbolic and constructive play). Three composite scores (social, speech, symbolic) and a total raw score are generated. Although designed for children aged 6 to 24 months, it can be used with older children who are functioning within this developmental range and thus is applicable to the target population of the MTW program. The investigators will record Social, Expressive Speech and Symbolic Communication composites and Total raw scores.
Changes from baseline in parent use of More Than Words strategies at post-program and follow-up
时间窗: Within 2 weeks before the waitlist period (control group only), 2 weeks before program start, 2 weeks after program end, 13-15 weeks after program end
The Parent Fidelity Scale was developed for this pilot RCT to assess parent's use of the MTW program communication facilitation strategies during interactions with their child. The scale includes 13 items reflecting the core strategies that are taught across the MTW program group sessions and that the SLP supports the parent to develop during the individual video feedback sessions. Each item will be rated on a 5-point Likert scale ranging from 1- Never/Rarely Used (never or only occasionally used the strategy, but almost all opportunities were missed) to 5 - Full Mastery (used the strategy effectively throughout the session, with very few or no missed opportunities). The rating scale will be coded from the same video-recorded interactions used for the JERI and CGI.
次要结局
未报告次要终点
研究者
Janis Oram
Full Professor
Western University, Canada