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A Pilot Randomized Clinical Trial of an Enhanced Pivotal Response Treatment Approach for Young Children with Autism: The PRISM Model

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Abstract

The symptoms of autism spectrum disorder are conceptualized to alter the quality of parent–children interactions, exposure to social learning exchanges, and ultimately the course of child development. There is evidence that modifying the procedures of Pivotal Response Treatment (PRT) to explicitly target social motivation enhances child engagement and parent–child synchrony in moment-by-moment exchanges. However, it is unclear if these within session improvements ultimately yield favorable developmental outcomes over time. The current investigation presents feasibility, utility, and preliminary efficacy data of a pilot randomized clinical trial (RCT) of a Pivotal Response Intervention for Social Motivation (PRISM) model. Data on participant factors, treatment protocol acceptability, and outcome variance and effect size are highly favorable and support the pursuit of a future, large scale RCT.

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Acknowledgements

The authors would like to acknowledge all of the families who participated in this research, along with all of the undergraduate research assistants and clinicians that made this project possible.

Funding

This study was funded by Autism Speaks.

Author information

Authors and Affiliations

  1. University of California Santa Barbara, Santa Barbara, CA, USA

    Ty W. Vernon, Anahita N. Holden, Amy C. Barrett, Jordan A. Ko, Elizabeth S. McGarry, Erin J. Horowitz, Daina M. Tagavi & Tamsin C. German

  2. University of South Carolina, Columbia, SC, USA

    Jessica Bradshaw

Authors
  1. Ty W. Vernon
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  2. Anahita N. Holden
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  3. Amy C. Barrett
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  4. Jessica Bradshaw
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  5. Jordan A. Ko
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  6. Elizabeth S. McGarry
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  7. Erin J. Horowitz
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  8. Daina M. Tagavi
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  9. Tamsin C. German
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Contributions

TWV served as PI for this RCT, trained and supervised the grant coordinators, and participated in the conceptualization, implementation, and data analysis of the clinical trial. ANH and ACB served as grant project coordinators and assisted with data analysis and the recruitment, training, and supervision of all research assistants. JB, EJH, and Co-PI TCG assisted with study conceptualization, design, and data analysis. ANH, ACB, JAK, and ESM were responsible for clinician recruitment, training, and supervision and also conducted parent training sessions. DMT assisted with major aspects of manuscript drafting and revision. All authors assisted with article preparation.

Corresponding author

Correspondence to Ty W. Vernon.

Ethics declarations

Conflict of interest

All authors declare that they have no conflicts of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Appendix A

Appendix A

Feasibility analytic plan, results, and proceed/modification decisions

Feasibility subdomain

Analytic strategy

Objective(s)

Result(s)

Objective met?

Proceed decision/modifications

Participant factors

 Recruitment

Recruitment was assessed by examining actual recruitment numbers versus predetermined recruitment goals

Adequate recruitment to yield target of 24 participants in 2 years

24 participants successfully enrolled in 2 years

Objective met

Proceed

 Randomization

The adequacy of randomization procedures was assessed by conducting independent sample T-tests of pre-trial characterization data between treatment and waitlist groups

Absence of significant between-group differences at baseline on demographic and assessment data

Absence of significant between-group differences on most primary measures. Group differences on Vineland-II

Objective nearly met

Proceed with modifications

Stratify by developmental performance prior to randomization

Treatment protocol

 Acceptability

Treatment acceptability was assessed by examining both participant completion percentage and parent post-trial ratings of program efficacy and satisfaction

80% intervention program completion

75% assigned to treatment group completed the program (85.7% completion percentage of families who started treatment)

Objective nearly met

Proceed with close monitoring

Mean rating of 8.00 on 0–10 agreement scale for parent survey rating items

Mean ratings ranged from 9.00 to 9.83 across items

Objective met

Proceed

 Dosage

Treatment dosage tolerance was assessed by reviewing participant session records to compare utilized hours with total hours offered

80% of allocated hours completed within the trial period (208 of the 260 total possible hours)

Mean of 68.35% of allocated hours were completed (177.70 of the 260 total possible hours)

Objective not met

Proceed with modifications

Reduce dosage to eight hours/ week and increase trial duration to 12 months

 Fidelity

Fidelity assessed parent intervention mastery by coding the final two parent intervention videos to determine the accuracy of caregiver delivered intervention

80% mean fidelity across final parent intervention videos

85.13% mean fidelity rating

Objective met

Proceed

Outcome

 Pre-post analyses

These analyses used paired sample T-tests on all measures to assess for evidence of significant differences

Significant t-test results on primary measures for the treatment group

Significant results on 66.6% of measures (4 of the 6: ADOS-2, Mullen, PLS-5, PPVT-4)

Objective partially met

Proceed with modifications

Increase trial duration to 12 months

 Effect size

Effect size assessed the magnitude of treatment effects experienced by treatment participants using Cohen’s d calculations

Evidence of medium to large effects (d > 0.50)

d > 0.50 on 66.6% of measures (4 of the 6: ADOS-2, Mullen, PLS-5, PPVT-4)

Objective partially met

Proceed with modifications

Increase trial duration to 12 months

 Variance

Variance assessed the range of outcomes of the treatment participants by calculating 95% confidence intervals for the effect sizes and comparing the overlap between groups

Evidence of at least small treatment effects (d > 0.20) on the lower bound of the 95% confidence intervals

Lower bound of d CI > 0.20 on 66.6% of measures (4 of the 6: ADOS-2, Mullen, PLS-5, PPVT-4)

Objective partially met

Proceed with modifications

Increase trial duration to 12 months

Minimal to no overlap in confidence interval ranges between treatment and waitlist groups

No overlap in confidence intervals on 33.3% of measures (2 of the 6). Marginal overlap on an additional 33.3% of measures (2 of the 6)

Objective partially met

Proceed with modifications

Increase trial duration to 12 months

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Vernon, T.W., Holden, A.N., Barrett, A.C. et al. A Pilot Randomized Clinical Trial of an Enhanced Pivotal Response Treatment Approach for Young Children with Autism: The PRISM Model. J Autism Dev Disord 49, 2358–2373 (2019). https://doi.org/10.1007/s10803-019-03909-1

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