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.
| Screening decision | Screening conclusion | HomVEE procedures and standards version |
|---|---|---|
| Passes screens | Eligible for review | Version 2 |
| Rating | Design | Attrition | Baseline equivalence | Compromised randomization | Confounding factors | Valid, reliable measure(s) |
|---|---|---|---|---|---|---|
| High | Randomized controlled trial | Low | Not assessed for randomized controlled trials with low attrition |
No | No |
Yes, details reported below for findings on valid, reliable outcomes that otherwise rate at least moderate |
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.
| 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. |
| Intervention services | iBasis-VIPP as implemented in the study consisted of 10 sessions delivered in the family home over a five-month period by a trained therapist. Therapists videotaped parent–child interactions and then used video excerpts to work with parents on improving their understanding of and sensitivity toward their infants’ communication style, helping them adapt to promote social and cognitive development. Therapists helped to frame observations, assist with caregivers’ self-reflection, and focus on change in the caregivers’ communicative responses to the infant. Between sessions, therapists asked caregivers to undertake daily home practice using targeted skills when interacting with their infants. The goal of the intervention was to improve caregivers’ sensitivity and reduce infants’ risk markers for ASD. Families also continued to receive usual community care for infants at risk of ASD. |
| 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 |
This field lists subgroups examined in the manuscript (even if they were not replicated in other samples and not reported on the summary page for this model’s report). • No sibling with ASD • Sibling with ASD |
| 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. |
| 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. |
| Peer reviewed | Yes |
Clinicaltrials.gov Identifier: None found. SocialScienceRegistry.org Identifier: None found. Registry of Efficacy and Effectiveness Studies Identifier: None found. Study registration was assessed by HomVEE for Clinicaltrials.gov beginning with the 2014 review, and for other registries beginning with the 2021 review.
| Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|
| High | Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant attentiveness |
FavorableUnfavorable or ambiguousNo Effect |
BASIS-VIPP vs. usual care RCT, Australia, 2016-2018 |
Treatment end point (6 months after baseline) |
94 parent/child dyads | Unadjusted mean = 4.43 | Unadjusted mean = 4.70 | Mean difference = -0.27 | HomVEE calculated = -0.24 | Not statistically significant, p = 0.24 |
HomVEE calculated significanceStatistical significance is based on HomVEE calculations. |
| High | Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant attentiveness |
FavorableUnfavorable or ambiguousNo Effect |
BASIS-VIPP vs. usual care RCT, Australia, 2016-2018 |
12 months after baseline |
84 parent/child dyads | Unadjusted mean = 4.60 | Unadjusted mean = 4.19 | Mean difference = 0.41 | HomVEE calculated = 0.34 | Not statistically significant, p = 0.12 |
HomVEE calculated significanceStatistical significance is based on HomVEE calculations. |
| High | Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant attentiveness |
FavorableUnfavorable or ambiguousNo Effect |
BASIS-VIPP vs. usual care RCT, Australia, 2016-2018 |
24 months after baseline |
80 parent/child dyads | Unadjusted mean = 5.02 | Unadjusted mean = 5.15 | Mean difference = -0.13 | HomVEE calculated = -0.11 | Not statistically significant, p = 0.61 |
HomVEE calculated significanceStatistical significance is based on HomVEE calculations. |
| High | Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant positive affect |
FavorableUnfavorable or ambiguousNo Effect |
BASIS-VIPP vs. usual care RCT, Australia, 2016-2018 |
Treatment end point (6 months after baseline) |
94 parent/child dyads | Unadjusted mean = 3.69 | Unadjusted mean = 4.40 | Mean difference = -0.71 | HomVEE calculated = -0.49 | Statistically significant, p = 0.02 |
HomVEE calculated significanceStatistical significance is based on HomVEE calculations. |
| High | Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant positive affect |
FavorableUnfavorable or ambiguousNo Effect |
BASIS-VIPP vs. usual care RCT, Australia, 2016-2018 |
12 months after baseline |
84 parent/child dyads | Unadjusted mean = 3.18 | Unadjusted mean = 3.21 | Mean difference = -0.03 | HomVEE calculated = -0.02 | Not statistically significant, p = 0.94 |
HomVEE calculated significanceStatistical significance is based on HomVEE calculations. |
| High | Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant positive affect |
FavorableUnfavorable or ambiguousNo Effect |
BASIS-VIPP vs. usual care RCT, Australia, 2016-2018 |
24 months after baseline |
80 parent/child dyads | Unadjusted mean = 4.02 | Unadjusted mean = 4.28 | Mean difference = -0.26 | HomVEE calculated = -0.13 | Not statistically significant, p = 0.56 |
HomVEE calculated significanceStatistical significance is based on HomVEE calculations. |
