Manuscript Details

Source

Peer reviewed?
Yes

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.

High rating
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.

Study Design

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

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 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.

Home Visiting 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 parentchild 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.

 

Were any subgroups examined?
No
Subgroups examined

There were no subgroups reported in this manuscript.

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.

Home Visiting 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 parentchild 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.

 

Were any subgroups examined?
No
Subgroups examined

There were no subgroups reported in this manuscript.

Findings that rate moderate or high in this manuscript

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

5 months

High
0.29

Not statistically significant, p= >.05

53 families

iBASIS-VIPP vs. usual care RCT, United Kingdom, 2011-2012

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

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 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): 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): 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