Manuscript Details

Whitehouse, A. J., Varcin, K. J., Pillar, S., Billingham, W., Alvares, G. A., Barbaro, J., ... & Hudry, K. (2021). Effect of preemptive intervention on developmental outcomes among infants showing early signs of autism: a randomized clinical trial of outcomes to diagnosis. JAMA Pediatrics, 175(11), e213298-e213298.

Peer Reviewed

High rating
Study reviewed under: Handbook of Procedures and Standards, Version 2
Study design characteristics contributing to rating
Design Attrition Baseline equivalence Confounding factors? Valid, reliable measures?
Randomized controlled trial Low

Not assessed for randomized controlled trials with low attrition

No

Yes, details reported below for findings on valid, reliable outcomes that otherwise rate at least moderate

Notes from the review of this manuscript

HomVEE calculations for statistical significance are used because the study reported statistical significance using one-sided p-values. Several findings in this study received a low rating due to high attrition and because they did not satisfy the baseline equivalence requirement: the Autism Observation Scale for Infants, the Autism Diagnostic Observation Schedule, the MacArthur Communicative Development Inventories, and the Parenting Sense of Competence scale.

Child Development and School Readiness
Outcome Measure Timing of Follow-Up Rating Direction of Effect Effect Size (Absolute Value) Stastical Significance Sample Size Sample Description
Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant attentiveness Treatment end point (6 months after baseline) High
0.24 Not statistically significant, p = 0.24 94 parent/child dyads BASIS-VIPP vs. usual care RCT, Australia, 2016-2018
Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant attentiveness 12 months after baseline High
0.34 Not statistically significant, p = 0.12 84 parent/child dyads BASIS-VIPP vs. usual care RCT, Australia, 2016-2018
Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant attentiveness 24 months after baseline High
0.11 Not statistically significant, p = 0.61 80 parent/child dyads BASIS-VIPP vs. usual care RCT, Australia, 2016-2018
Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant positive affect Treatment end point (6 months after baseline) High
0.49 Statistically significant, p = 0.02 94 parent/child dyads BASIS-VIPP vs. usual care RCT, Australia, 2016-2018
Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant positive affect 12 months after baseline High
0.02 Not statistically significant, p = 0.94 84 parent/child dyads BASIS-VIPP vs. usual care RCT, Australia, 2016-2018
Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant positive affect 24 months after baseline High
0.13 Not statistically significant, p = 0.56 80 parent/child dyads BASIS-VIPP vs. usual care RCT, Australia, 2016-2018
Effect rating key
Favorable finding / Statistically significant
Unfavorable finding / Statistically significant
Ambiguous finding / Statistically significant
No effect / Not statistically significant

This study included participants with the following characteristics at enrollment:

Race/Ethnicity

Data not available

Maternal Education

Bachelor's degree or higher
60%
Unknown
40%

Other Characteristics

Data not available

This study included participants from the following locations:

  • State not reported or international
International Locations
Australia
Study Participants

The study invited families with an infant from 9 to 15 months who displayed at least three behavioral characteristics associated with autism spectrum disorder (ASD) to participate. Families were not eligible if their infant had any comorbidity that could affect neurological or developmental abilities or if at least one caregiver did not speak English. The study randomly assigned eligible families to either the iBASIS-Video Interaction to Promote Positive Parenting (iBASIS-VIPP) home visiting intervention plus usual care or usual care only. Of the 171 infants assessed for eligibility, 104 were eligible and randomly assigned to condition, with 51 assigned to iBASIS-VIPP and 53 to usual care only. Infants were 9 to 15 months at enrollment and 33 to 39 months at the latest follow-up in the study (24 months after enrollment). Most infants (76 percent) were male and living with both biological parents (98 percent). Most study households (82 percent) had annual incomes over $50,000; more than half of mothers had a university degree. The authors did not report the race or ethnicity of participants.

Setting

The study took place in Perth and Melbourne, Australia.

Comparison Conditions

Families assigned to the comparison condition did not receive iBASIS-VIPP. They continued to receive usual community care for infants at risk of ASD. This comprised services recommended by health professionals within the local community, including a range of allied health services, comprehensive autism interventions, or no services. 

Subgroups examined

• No sibling with ASD • Sibling with ASD

Author Affiliation

The authors are affiliated with several institutions. Several of the study authors provided input into the development of iBASIS-VIPP. Dr. Green, one of the study authors, was a co-developer of the iBASIS-VIPP intervention.

Funding Sources

The research was supported by Award Numbers 1077966 and 1173896 from Australia’s National Health and Medical Research Council and by the Telethon Kids Institute.