Parent-Mediated Intervention for Autism Spectrum Disorder

(PRIMeR Trial)

Overseen By Isabel M Smith, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: IWK Health Centre

Disqualifiers: Severe sensory or motor impairment, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of parent coaching for young children with autism spectrum disorder (ASD) to determine which is most effective. One method employs a new approach called PRIMeR, which focuses on social routines and imitation, while the other uses established strategies known as Pivotal Response Treatment (PRT). The goal is to assist children in Nova Scotia's early intervention program who have not yet shown significant progress. Ideal participants are preschoolers with ASD who use 10 or fewer words functionally and exhibit limited play with toys or positive emotions. As an unphased trial, this study provides families with a unique opportunity to contribute to innovative research that could enhance early intervention strategies for children with ASD.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Pivotal Response Treatment (PRT) is a well-researched therapy that helps children with autism improve their social communication skills. It targets key areas of a child's development, such as motivation and social interactions. Studies have found that PRT is generally safe, with no major safety concerns.

PRIMeR is a new method that builds on PRT. Although specific safety data for PRIMeR is not yet available, it uses techniques like Social Routines and Reciprocal Imitation Training, which are similar to PRT. Therefore, they are expected to be safe as well. Both treatments aim to enhance communication and responsiveness in children and do not involve invasive procedures or medications, reducing the risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parent-Mediated Intervention for Autism Spectrum Disorder because it offers a novel approach to supporting children with autism through virtual parent coaching. This trial explores two distinct strategies: PRIMeR and PRT. PRIMeR is unique as it combines Social Routines and Reciprocal Imitation Training, potentially enhancing social interaction skills in a natural, engaging way. Meanwhile, PRT focuses on Pivotal Response Treatment strategies, aiming to improve communication and behavior by targeting pivotal areas of a child's development. These methods are particularly appealing because they empower parents to actively participate in their child's therapy from home, making them more accessible and personalized compared to traditional in-office therapies.

What evidence suggests that this trial's treatments could be effective for autism?

Research shows that Pivotal Response Treatment (PRT), one of the treatments in this trial, can improve social communication skills in children with autism. Studies have found that PRT enhances social and emotional behaviors in young children with autism spectrum disorder (ASD). However, some research indicates it may not significantly improve communication or language skills for all children.

The PRIMeR intervention, another treatment arm in this trial, uses PRT strategies, such as social routines and imitation training, to increase responsiveness. Although specific data on PRIMeR alone is limited, it is based on the proven principles of PRT, which studies have shown to benefit children with autism. By involving parents more directly, PRIMeR aims to make PRT more effective for children who did not respond well to traditional methods. ^{1 2 3 5 6}

Who Is on the Research Team?

Isabel M Smith, PhD

Principal Investigator

IWK Health Centre and Dalhousie University

Are You a Good Fit for This Trial?

This trial is for preschoolers with autism spectrum disorder in Nova Scotia who show minimal response to standard treatments. They should have limited positive emotions, use fewer than 10 words spontaneously, and be about to enroll in the NS EI program. Children with severe sensory or motor impairments or whose parents can't consent in English are excluded.

Inclusion Criteria

Current spontaneous functional use of ≤ 10 words (clinician's observations; parent report using MacArthur-Bates Communicative Development Inventory - Words & Gestures (CDI-WG)

My child uses toys or objects less than expected.

Significant delay in cognitive abilities (assessed formally by psychologist or estimated by psychologist or developmental pediatrician at time of diagnosis)

Exclusion Criteria

I cannot complete the consent process or receive coaching in English.

My child has severe difficulties in feeling or moving.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Virtual Parent-Coaching Intervention

Parents receive virtual coaching in either PRIMeR or PRT strategies to enhance child responsivity

6 months

Virtual sessions

Follow-up

Participants are monitored for gains in social initiations and communication levels

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PRIMeR
• PRT

Trial Overview The study tests a brief parent-led intervention called PRIMeR aimed at increasing children's responsiveness to Pivotal Response Treatment (PRT), an existing method used by the publicly funded autism early intervention program in Nova Scotia.

How Is the Trial Designed?

Group I: PRIMeR Experimental Treatment 1 Intervention

Virtual parent coaching in use of a novel intervention consisting of Social Routines and Reciprocal Imitation Training strategies

Group II: PRT Active Control 1 Intervention

Virtual parent coaching in use of Pivotal Response Treatment strategies

PRIMeR is already approved in United States, Canada, European Union, China for the following indications:

Approved in United States as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)

Approved in Canada as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)

Approved in European Union as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)

Approved in China as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)

Who Is Running the Clinical Trial?

IWK Health Centre

Lead Sponsor

Trials

131

Recruited

112,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Training parents to use the Natural Language Paradigm (NLP) effectively increased the frequency of verbalizations in their nonverbal and echolalic autistic children, demonstrating the method's efficacy.

After initial training in a clinic, parents successfully implemented NLP at home, leading to improvements in their children's speech across various settings, not just during training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training parents to use the natural language paradigm to increase their autistic children's speech. Laski, KE., Charlop, MH., Schreibman, L.[2019]

A randomized controlled trial involving 53 children with autism showed that parents trained in Pivotal Response Treatment (PRT) significantly improved their children's language skills compared to those in a psychoeducation group, with a notable increase in the frequency of child utterances.

The study demonstrated that 84% of parents in the PRT group effectively learned and implemented the techniques, leading to enhanced adaptive communication skills in their children, highlighting the efficacy of PRT as a parent training model for addressing language deficits in young children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism. Hardan, AY., Gengoux, GW., Berquist, KL., et al.[2022]

Pivotal Response Training (PRT) has shown statistically significant effects in improving language and communication skills for individuals with autism spectrum disorder (ASD), based on a systematic review of 10 randomized controlled trials (RCTs).

While PRT demonstrates promise for language outcomes, the evidence for its effectiveness in other areas is less consistent, highlighting the need for improved study designs to better understand treatment responses and develop tailored guidelines for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining Effectiveness and Predictors of Treatment Response of Pivotal Response Treatment in Autism: An Umbrella Review and a Meta-Analysis. Uljarević, M., Billingham, W., Cooper, MN., et al.[2022]

Pivotal response treatment (PRT) has been shown to be an effective intervention for improving communication and social functioning in children with autism spectrum disorder (ASD), based on a systematic evaluation of 17 studies.

The studies demonstrated strong adherence to several research quality standards, such as using standardized protocols and objective evaluators, but showed variability in treatment fidelity and the use of longitudinal designs, indicating areas for improvement in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal response treatment for children with autism spectrum disorder: a systematic review of research quality. Cadogan, S., McCrimmon, AW.[2018]

In a randomized controlled trial involving 44 children with Autism Spectrum Disorder (ASD), Pivotal Response Treatment (PRT) led to significant improvements in social-communicative skills after 12 weeks compared to treatment-as-usual (TAU).

PRT also showed larger gains in global functioning and adaptive socialization skills, indicating its potential effectiveness as a therapeutic intervention for children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal Response Treatment for School-Aged Children and Adolescents with Autism Spectrum Disorder: A Randomized Controlled Trial. de Korte, MWP., van den Berk-Smeekens, I., Buitelaar, JK., et al.[2021]

The six-week parent training program for Pivotal Response Treatment (PRT) effectively taught four parents to implement the intervention with high fidelity, enhancing their interactions with their children with autism spectrum disorder (ASD).

Parents reported high satisfaction with the program, indicating that PRT parent training is a promising, efficient, and cost-effective treatment model for improving parent-child interactions in ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Parent-Implemented Pivotal Response Treatment for Children with Autism Spectrum Disorder. Bozkus-Genc, G., Yucesoy-Ozkan, S.[2023]

Parents of children with autism spectrum disorder (ASD) found Pivotal Response Treatment with parent group training (PRT-PG) to be feasible and effective, reporting improvements in their child's social-communication skills and overall well-being.

The study highlighted that parents gained valuable insights into their child's needs and their own communication habits, which contributed to positive changes in family cohesion during the 14-week program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal Response Treatment (PRT) - Parent Group Training for Young Children with Autism Spectrum Disorder: A Qualitative Study on Perspectives of Parents. de Korte, MWP., Kaijadoe, SPT., Buitelaar, JK., et al.[2022]

A pilot study tested a developmental adaptation of Pivotal Response Treatment (PRT) with three infants at-risk for autism, showing promising results in enhancing their functional communication skills.

The introduction of PRT also improved parents' ability to implement the treatment effectively, suggesting that this approach could be a feasible intervention for very young children at-risk for autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal response treatment for infants at-risk for autism spectrum disorders: a pilot study. Steiner, AM., Gengoux, GW., Klin, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5488784/

Pivotal response treatment for autism spectrum disorder PRT is an evidence-based behavioral intervention based on applied behavior analysis principles aimed to improve social communication skills in individuals with ...

2. ies.ed.gov ies.ed.gov/ncee/wwc/Docs/InterventionReports/wwc_prt_011017.pdf

Pivotal Response Training - Institute of Education Sciences PRT was found to have no discernible effects on communication/language competencies for children and students with an autism spectrum disorder. Table 1. Summary ...

3. link.springer.com link.springer.com/article/10.1007/s40489-013-0008-z

Pivotal Response Treatment for Children with Autism ... Another synthesis of research on PRT concluded that PRT effectively improved social and emotional behaviors of young children with ASD (Masiello ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4194254/

A Randomized Clinical Trial Comparison Between Pivotal ... The results of this study showed that the PRT intervention was more effective at improving social communication skills for children with autism than the ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1750946719301850

Results from a pilot RCT of the PRISM model Participants who received Pivotal Response Intervention for Social Motivation showed improved social engagement and expressive language. •. Participants who ...

6. cebc4cw.org cebc4cw.org/program/pivotal-response-treatment-prt/

CEBC » Program › Pivotal Response Treatment Prt PRT® is designed to target pivotal areas of a child's development, such as motivation, responsivity to multiple cues, self-management, and social initiations.