About this trial
"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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
The Hanen Centre's More Than Words® program
BehavioralThe Hanen Centre's More Than Words® program is a globally used, parent coaching intervention delivered by speech-language pathologists (SLPs) to parents of children who have social communication challenges, which includes children with 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.
Treatment groups
Trial outcomes
Primary outcomes
Changes from baseline in Child Communicative Participation at post-program and follow-up
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
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
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
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).
Sponsors and contacts
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Western University, Canada
Lead sponsor
The Hanen Centre, Toronto
Collaborator