Feasibility Trial of Parent-delivered Social Communication Program

NCT06847347 | Completed

• 1 other identifier: 120218
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Communication Disorder; Autism

Keywords

autism; social communication; parent coaching; speech-language pathology; More Than Words

Outcome Measures

Primary Outcomes (13)

• Recruitment capability

  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.

  From up to 3 months to 1 week before families begin a More Than Word program being offered in their community

• Reasons for nonenrollment

  Reasons for speech-language pathologists and parents declining participation

  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

• Overall rate of study measure completion

  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.

  The investigtors calculate the overall rate of study measure completion within 1 year after the study closes

• Time required for the investigators to code videos

  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.

  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

• Perceived feasibility and acceptability of study methods

  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

  Within 3 months of the families finishing the More Than Words program

• Change in prelinguistic and early communication skills

  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)

  Within 2 weeks before and within 2 weeks after the 13-week More Than Words program

• Change in child's communicative participation

  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.

  Within 2 weeks before and within 2 weeks after the 13-week More Than Words program

• Child's social communication stage and skills

  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.

  During the pre-program consultation session (week 2) of the More Than Words program and again within 2 weeks after the program ends.

• Change in severity of child's social communication challenges

  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

  Videos are recorded during the Pre-Program Consultation session (week 2) and the third Video Feedback Session (week 12)

• Change in child and parent social engagement and interaction

  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

  Videos are recorded during the Pre-Program Consultation session (week 2) and the third Video Feedback Session (week 12)

• Change in parent self-efficacy

  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).

  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.

• Change in parent strategy use

  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.

  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.

• Perceived program effectiveness according to parents

  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

  During the final group session (week 13) of the More Than Words program

Study Arms (1)

Feasibility testing

EXPERIMENTAL

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.

Behavioral: More Than Words®

Interventions

More Than Words® BEHAVIORAL

More Than Words® (MTW) is a 13-week parent-implemented program designed to enhance communication, play development, and parent-child interaction for children under 4 years of age who have autism or social communication challenges. MTW is delivered by speech-language pathologists (SLPs) certified by The Hanen Centre, a global not-for-profit organization based in Toronto. MTW is delivered virtually in this trial. The program an orientation session, an individual pre-program consultation appointment, 8 x 2½ hour group training sessions (with 6-8 parents per group), and 3 individual video feedback sessions. During video feedback, the parent demonstrates use of communication facilitation strategies with their child, while the SLP records the interactions. The parent and SLP then review the videos together, analyze use of the strategies and how the child responded, and formulate plans to foster development of new skills.

Feasibility testing

Eligibility Criteria

• Age: Up to 47 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• B. Parents
• 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

Sponsors & Collaborators

• Western University, Canada: lead
• The Hanen Centre: collaborator

Study Sites (1)

Western University

London, Ontario, N5G 1H1, Canada

Location

MeSH Terms

Conditions

Social Communication Disorder; Autistic Disorder; Communication

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Behavior

Study Officials

• Janis Oram

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single arm methodological feasibility trial

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 26, 2025
• Study Start: January 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)