Parent-Mediated Intervention for Autism Spectrum Disorder

(PRIMeR Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Isabel M Smith, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: IWK Health Centre

Disqualifiers: Severe sensory or motor impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests two therapies for young children with autism who haven't responded well to usual treatments. The therapies involve parents playing with their children to encourage communication and social skills. One therapy focuses on general improvement, while the other targets specific weaknesses.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment PRIMeR for autism spectrum disorder?

Research shows that Pivotal Response Treatment (PRT), a key component of PRIMeR, is effective in improving communication and social skills in children with autism. Studies indicate that parents trained in PRT can help increase their children's speech and social interactions, making it a promising approach for autism treatment. ^{1 2 3 4 5}

Is parent-mediated intervention for autism spectrum disorder safe for humans?

The studies reviewed focus on the effectiveness of parent-mediated interventions like Pivotal Response Treatment (PRT) and Natural Language Paradigm (NLP) for improving communication in children with autism. They do not report any safety concerns, suggesting these interventions are generally safe for use in humans. ^{1 2 3 6 7}

How is the Parent-Mediated Intervention for Autism Spectrum Disorder treatment different from other treatments?

This treatment is unique because it involves training parents to use Pivotal Response Treatment (PRT) techniques at home, focusing on improving communication and social skills in a natural play environment. It empowers parents to actively participate in their child's therapy, which can lead to increased speech and social interaction in children with autism. ^{1 2 3 6 8}

Research Team

Isabel M Smith, PhD

Principal Investigator

IWK Health Centre and Dalhousie University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• PRIMeR (Behavioural Intervention)
• PRT (Behavioural Intervention)

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.

Participant Groups

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 Canada, China for the following indications:

Approved in Canada 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+

Dr. Doug Sinclair

IWK Health Centre

Chief Medical Officer

MD from Dalhousie University

Dr. Krista Jangaard

IWK Health Centre

Chief Executive Officer since 2018

MD and Masters of Health Administration from Dalhousie University

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Training parents to use the natural language paradigm to increase their autistic children's speech. [2019]

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

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

3. United States 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. [2022]

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

Pivotal response treatment for infants at-risk for autism spectrum disorders: a pilot study. [2021]

5. Switzerland 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism. [2022]

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

Pivotal Response Treatment for School-Aged Children and Adolescents with Autism Spectrum Disorder: A Randomized Controlled Trial. [2021]

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

Efficacy of a Parent-Implemented Pivotal Response Treatment for Children with Autism Spectrum Disorder. [2023]