Caregiver Training to Support Children With Social Communication Challenges

NCT06909279 | Recruiting

• 1 other identifier: 126148
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

"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.

Conditions

Autism Spectrum Disorder; Suspected Autism; Social Communication Challenges

Keywords

Autism; Parent mediated; Hanen More Than Words; Tele practice; Social communication challenges; pilot pragmatic RCT; virtual care

Outcome Measures

Primary Outcomes (6)

• 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.

  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

• 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.

  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

• 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).

  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

• 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).

  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

• Changes from baseline in child prelinguistic skills at post-program and follow-up

  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.

  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

• Changes from baseline in parent use of More Than Words strategies at post-program and follow-up

  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.

  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

Study Arms (2)

Virtual MTW Treatment Group (TG)

EXPERIMENTAL

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).

Behavioral: The Hanen Centre's More Than Words® program

Waitlist Control Group (WCG)

NO INTERVENTION

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.

Interventions

The Hanen Centre's More Than Words® program BEHAVIORAL

The 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.

Virtual MTW Treatment Group (TG)

Eligibility Criteria

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

You may qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Western University

London, Ontario, N6G1H1, Canada

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Janis Oram, PhD, S-LP(C)

CONTACT

519-661-2111; janis.oram@uwo.ca

Arlene Fleischhauer

CONTACT

519-661-2111; afleisc@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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 .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: This will be a pilot pragmatic, randomized waitlist controlled trial design, where participants will be randomly assigned to either the virtual MTW Treatment Group (TG) or a Waitlist Control Group (WCG). By focusing on real-world implementation, this will allow us to capture how the MTW program operates outside of controlled environments.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 3, 2025
• Study Start: May 6, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)