Recruiting

Observational Study

Sponsor:

Western University, Canada

Code:

NCT06909279

Conditions

Autism Spectrum Disorder

Suspected Autism

Social Communication Challenges

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

The Hanen Centre's More Than Words® program

Study Details

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

Study ID

NCT06909279

Start date

May 6, 2025

Status verified date

May, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Inclusion criteria:

1. The child is under 48 months of age at the time of study enrolment.
2. The child has delays in social communication and play skills according to the clinical assessment of the child's community SLP.
3. 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
4. The parent is available to attend the 13-week virtual MTW program (which includes 9 online group sessions on Saturday mornings or Monday evenings).
5. The parent is comfortable communicating and filling out forms in English.

Exclusion Criteria:

Failure to meet the inclusion criteria outlined above.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

no intervention: 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.

Interventions

The Hanen Centre's More Than Words® program

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.

Primary outcome measure

  • Changes from baseline in Child Communicative Participation at post-program and follow-up [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Janis Oram, PhD, S-LP(C)

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

Arlene Fleischhauer

519-661-2111afleisc@uwo.ca

Locations

Western University

Recruiting

London, Ontario, Canada, N6G1H1

Contacts

Janis Oram, PhD S-LP(C)

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

Principal Investigator:

Janis Oram, PhD S-LP(C)

More Information

Sponsor

Western University, Canada

Last update posted

May 11, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Western University, Canada on 2025-05-11.