Caregiver Training for Autism Spectrum Disorder

Overseen By Arlene Fleischhauer

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Over 48 months, No internet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 13 weeks

72 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment The Hanen Centre's More Than Words® program for Autism Spectrum Disorder?

Research shows that training caregivers using real-time feedback and behavioral skills training can effectively teach them to help children with autism spectrum disorder (ASD) with daily living skills. This suggests that caregiver training programs, like The Hanen Centre's More Than Words®, may be effective in supporting children with ASD. ^{1 2 3 4 5}

Is caregiver training for autism spectrum disorder safe for humans?

The available research on caregiver training programs for autism spectrum disorder, such as behavioral parent training and parent education, suggests they are generally well-received and considered acceptable by participants, indicating they are safe for humans. ^{2 6 7 8 9}

How is the More Than Words® treatment different from other autism treatments?

The More Than Words® program is unique because it focuses on training caregivers to use everyday interactions to improve communication and social skills in children with autism, rather than relying solely on direct therapy from professionals. This approach empowers caregivers to be active participants in their child's development, making it more accessible and potentially more effective in everyday settings. ^{5 10 11 12 13}

What is the purpose of 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 is for parents of children with Autism Spectrum Disorder or those who could benefit from social communication support. It's designed to help them use the More Than Words program, which is delivered by speech-language pathologists and can be accessed virtually.

Inclusion Criteria

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

My child is younger than 4 years old.

Exclusion Criteria

Failure to meet the inclusion criteria outlined above.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual)

Pre-Program Consultation

SLP conducts an informal assessment of the child's communication and records a video of the parent-child interaction

1 week

1 visit (virtual)

Treatment

Parents participate in the 13-week virtual MTW program, including group training and individual video feedback sessions

13 weeks

8 group sessions, 3 individual sessions (virtual)

Follow-up

Participants are monitored for changes in communication skills and parent self-efficacy after the program

13-15 weeks

Data collection via surveys and video submissions

Treatment Details

Interventions

• The Hanen Centre's More Than Words® program

Trial Overview The study tests the updated More Than Words program, focusing on its effectiveness when delivered online. It compares outcomes between families using the program and those not yet receiving it, aiming to refine methods for a larger future study.

Participant Groups

Group I: Virtual MTW Treatment Group (TG) Experimental Treatment 1 Intervention

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).

Group II: Waitlist Control Group (WCG) Active Control 1 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.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

The Hanen Centre, Toronto

Collaborator

Findings from Research

A study involving 1,089 ABA providers revealed that the number of professional training experiences significantly influences how extensively these providers use parent training strategies for children with autism spectrum disorder (ASD).

Only 15% of providers utilized manualized parent training programs, but those who did were more likely to implement parent training effectively, highlighting the importance of structured resources in enhancing treatment practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Professional Training Experiences and Manualized Programs in ABA Providers' Use of Parent Training With Children With Autism. Ingersoll, B., Straiton, D., Caquias, NR.[2020]

A pilot study involving 38 caregivers of children with autism spectrum disorder (ASD) evaluated a novel 6-session brief behavioral parent training (BPT) that effectively targeted high-frequency challenging behaviors.

Caregivers who participated in the BPT reported higher satisfaction and acceptability compared to those in the active control group, indicating that this intervention is both feasible and well-received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Evaluation of a Brief Behavioral Parent Training for Challenging Behavior in Autism Spectrum Disorder. Rohacek, A., Baxter, EL., Sullivan, WE., et al.[2023]

In a study involving 280 caregivers of children aged 6 to 11 on the autism spectrum, it was found that children received a wide range of interventions, with some receiving up to 79.3 hours per week, highlighting the complexity of treatment environments.

Children with higher autism symptom levels and certain demographic factors received more evidence-based interventions, suggesting that these factors should be considered when designing clinical trials for autism treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of Intervention Utilization Among School-Aged Children with Autism Spectrum Disorder: Findings from a Multi-Site Research Consortium. Sridhar, A., Kuhn, J., Faja, S., et al.[2023]

Out of 1,231 studies evaluated, only 36 included a parent education component aimed at improving expressive verbal communication in nonverbal or minimally verbal children with autism spectrum disorder, highlighting a significant gap in research.

The review found considerable variability in the design and implementation of parent education programs, with unclear descriptions and few studies measuring how well parents implemented the interventions, suggesting a need for more standardized approaches in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent Education in Studies With Nonverbal and Minimally Verbal Participants With Autism Spectrum Disorder: A Systematic Review. Koegel, LK., Bryan, KM., Su, PL., et al.[2021]

A study involving 13 families showed that parent training in the Naturalistic Developmental Behavioral Intervention, Project ImPACT, is feasible and positively received in community settings.

Parents reported finding value in their involvement in the intervention, perceiving benefits for their children, which highlights the importance of parent engagement in early autism interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent perceptions of an adapted evidence-based practice for toddlers with autism in a community setting. Stahmer, AC., Brookman-Frazee, L., Rieth, SR., et al.[2018]

A pilot program in Ontario tested two approaches for coaching caregivers of children with autism, showing that both observation followed by coaching and immediate coaching led to significant improvements in children's social engagement, play, and communication skills.

The intervention was effectively delivered by practitioners, achieving an average success rate of 83%, but attendance for follow-up booster sessions was inconsistent, highlighting the need for more research to tailor interventions to diverse caregiver needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring coaching and follow-up supports in community-implemented caregiver-mediated JASPER intervention. Shire, SY., Shih, W., Barriault, T., et al.[2022]

Caregiver training interventions for children with autism can effectively enhance social interaction, communication, and positive behaviors, and these interventions can be successfully delivered via telehealth, showing similar positive outcomes as in-person training.

Telehealth methods offer advantages such as cost-effectiveness and increased accessibility, making them a promising solution to address the global treatment gap for families of children with autism, although further research is needed to evaluate their effectiveness across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth-delivered caregiver training for autism: Recent innovations. Pacione, L.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Caregiver Training Procedures to Teach Activities of Daily Living Skills. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Quasi-experimental Controlled Study on the Effect of Autism Resource Clinic Guardian Attendance at a Military Treatment Facility. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The Role of Professional Training Experiences and Manualized Programs in ABA Providers' Use of Parent Training With Children With Autism. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Protective Factors Against Distress for Caregivers of a Child with Autism Spectrum Disorder. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Self-reported needs of caregivers of people with Autism Spectrum Disorder. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A Preliminary Evaluation of a Brief Behavioral Parent Training for Challenging Behavior in Autism Spectrum Disorder. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Patterns of Intervention Utilization Among School-Aged Children with Autism Spectrum Disorder: Findings from a Multi-Site Research Consortium. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Parent Education in Studies With Nonverbal and Minimally Verbal Participants With Autism Spectrum Disorder: A Systematic Review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Parent perceptions of an adapted evidence-based practice for toddlers with autism in a community setting. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Exploring coaching and follow-up supports in community-implemented caregiver-mediated JASPER intervention. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Telehealth-delivered caregiver training for autism: Recent innovations. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Positive Effects of the Caregiver Skill Training Program on Children With Developmental Disabilities: Experiences From Serbia. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of the World Health Organization's Caregiver Skills Training implemented in the Italian National Health System. [2022]