Manuscript Details

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.

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

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.

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 affect 5 months High
0.19 Not statistically significant, p= >0.05 53 families iBASIS-VIPP vs. usual care RCT, United Kingdom, 2011-2012
Manchester Assessment of Caregiver-Infant Interaction (MACI): Infant attentiveness 5 months High
0.29 Not statistically significant, p= >.05 53 families iBASIS-VIPP vs. usual care RCT, United Kingdom, 2011-2012
Effect rating key
Favorable finding / Statistically significant
Unfavorable finding / Statistically significant
Ambiguous finding / Statistically significant
No effect / Not statistically significant
Positive Parenting Practices
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): Caregiver non-directiveness 5 months High
0.81 Statistically significant, p= <0.05 53 families iBASIS-VIPP vs. usual care RCT, United Kingdom, 2011-2012
Manchester Assessment of Caregiver-Infant Interaction (MACI): Caregiver sensitive responding 5 months High
0.06 Not statistically significant, p= >0.05 53 families iBASIS-VIPP vs. usual care RCT, United Kingdom, 2011-2012
Manchester Assessment of Caregiver-Infant Interaction (MACI): Dyadic mutuality 5 months High
0.05 Not statistically significant, p= >0.05 53 families iBASIS-VIPP vs. usual care RCT, United Kingdom, 2011-2012
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

The race and ethnicity categories may sum to more than 100 percent if Hispanic ethnicity was reported separately or respondents could select two or more race or ethnicity categories.

White
74%
Unknown
26%

Maternal Education

Data not available

Other Characteristics

Data not available

This study included participants from the following locations:

  • State not reported or international
International Locations
United Kingdom
Study Participants

Participants included parentchild 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.

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

There were no subgroups reported in this manuscript.

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.

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.