Green, J., Charman, T., Pickles, A., Wan, M. W., Elsabbagh, M., Slonims, V., . . . Jones, E. J. (2015). Parent-mediated intervention versus no intervention for infants at high risk of autism: A parallel, single-blind, randomized trial. The Lancet Psychiatry, 2(2), 133–140.
| 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 |
The manuscript provides evidence of reliability for the Manchester Assessment of Caregiver-Infant Interaction (MACI). The manuscript does not provide evidence of reliability for any other measure. Because of this, all measures in the study other than the MACI received a low rating. Models controlled for race and ethnicity and baseline measures of the outcomes.
| Study participants | Participants included parent–child dyads in which a sibling of the child had received an autism spectrum disorder (ASD) diagnosis. The study identified participants from the British Autism Study of Infant Siblings (BASIS). Eligible participants were families with children ages 7 to 10 months who were not born prematurely (before 34 weeks) or with low birthweight (under 5 pounds). Families enrolled at one of two trial sites in Manchester or London, United Kingdom. The study randomly assigned families within each site to either the iBASIS-Video Interaction to Promote Positive Parenting (iBASIS-VIPP) home visiting intervention or usual care. Families continued their participation in the BASIS study, which did not involve an intervention. The study included 54 families, 28 in the intervention and 26 in the comparison group. At baseline, 74 percent of mothers identified as White and 26 percent identified as another race or ethnicity. Children were 9 months old on average at study enrollment. More than half (57 percent) of participants had annual household incomes of less than £40,000. |
|---|---|
| Setting | The study took place in London and Manchester, United Kingdom, at Evelina Children's Hospital and University of Manchester, respectively. |
| Intervention services | iBASIS-VIPP participants received up to 12 video-feedback sessions (6 standard sessions and up to 6 additional booster sessions) conducted by two speech and language therapists in the home setting. 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. The goal of the intervention was to reduce infants’ risk markers for ASD, for which they were at heightened risk as each had an older sibling diagnosed with ASD. The study assessed outcomes through videotaped play interactions and parents’ self-report. |
| Comparison conditions | Families assigned to the comparison condition were not offered 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). There were no subgroups reported in this manuscript. |
| Funding sources | This research was supported by Award Number G0701484 from the UK Medical Research Council and from funding from Autistica, the Waterloo Foundation, and Autism Speaks. |
| Author affiliation | The authors are affiliated with several institutions, including the University of Manchester, King’s College London, and Birkbeck College, and were developers of the iBASIS adaptation of the original 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.
Findings that rate moderate or high
| 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 affect |
FavorableUnfavorable or ambiguousNo Effect |
iBASIS-VIPP vs. usual care RCT, United Kingdom, 2011-2012 |
5 months |
53 families | Unadjusted mean = 4.85 | Unadjusted mean = 4.84 | Mean difference = 0.01 | Study reported = 0.19 | Not statistically significant, p= >0.05 |
|
| High | Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant attentiveness |
FavorableUnfavorable or ambiguousNo Effect |
iBASIS-VIPP vs. usual care RCT, United Kingdom, 2011-2012 |
5 months |
53 families | Unadjusted mean = 4.22 | Unadjusted mean = 4.19 | Mean difference = 0.31 | Study reported = 0.29 | Not statistically significant, p= >.05 |
| 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): Caregiver non-directiveness |
FavorableUnfavorable or ambiguousNo Effect |
iBASIS-VIPP vs. usual care RCT, United Kingdom, 2011-2012 |
5 months |
53 families | Unadjusted mean = 4.67 | Unadjusted mean = 3.92 | Mean difference = 0.75 | Study reported = 0.81 | Statistically significant, p= <0.05 |
|
| High | Manchester Assessment of Caregiver-Infant Interaction (MACI): Caregiver sensitive responding |
FavorableUnfavorable or ambiguousNo Effect |
iBASIS-VIPP vs. usual care RCT, United Kingdom, 2011-2012 |
5 months |
53 families | Unadjusted mean = 4.30 | Unadjusted mean = 4.58 | Mean difference = -0.28 | Study reported = -0.06 | Not statistically significant, p= >0.05 |
|
| High | Manchester Assessment of Caregiver-Infant Interaction (MACI): Dyadic mutuality |
FavorableUnfavorable or ambiguousNo Effect |
iBASIS-VIPP vs. usual care RCT, United Kingdom, 2011-2012 |
5 months |
53 families | Unadjusted mean = 3.22 | Unadjusted mean = 3.46 | Mean difference = -0.24 | Study reported = 0.05 | Not statistically significant, p= >0.05 |