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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, randomised trial. The Lancet Psychiatry, 2(2), 133–140.

Model(s) Reviewed: iBASIS - VIPP
Manuscript screening details
Screening decision Screening conclusion HomVEE procedures and standards version
Passes screens Eligible for review Version 1
Study design details
Rating Design Attrition Baseline equivalence Compromised randomization Confounding factors Valid, reliable measure(s)
High Randomized controlled trial Low Established on SES and baseline measures of the outcome; not established on race/ethnicity No No Not assessed in manuscripts reviewed before 2021
Notes:

Three outcomes (Parent Reported Gestures - MacArthur-Bates Communicative Development Inventory (MCDI) and 2 measures of event-related potentials to speech sounds (ERP)) were assigned low ratings because they had high attrition and did not satisfy the baseline equivalence requirements. All analyses included statistical controls for race/ethnicity and baseline measures of the outcomes.

Study characteristics
Study participants Participants were 54 parent–child dyads where a sibling of the child was diagnosed with autism spectrum disorder (ASD). Participating dyads were identified from the British Autism Study of Infant Siblings (BASIS). Eligible participants were families with children ages 7 to 10 months who were not born premature (before 34 weeks) or with low birthweight (less than 5 pounds). Families were enrolled at one of two trial sites in Manchester or London, United Kingdom. Dyads were randomly assigned within each site to either the home visiting intervention or care-as-usual comparison condition. Outcomes were assessed through video-recorded play interactions and through parent self-report. At baseline, 64 percent of intervention group mothers identified as white. The average child age was 267 days, or approximately 9 months. The participating parents’ age or gender was not reported. Fifty-nine percent had annual household incomes of less than £40,000.
Setting London and Manchester, United Kingdom
Intervention services iBASIS-VIPP dyads received up to 12 video-feedback sessions (as many as 6 booster sessions in addition to the standard 6 sessions in the VIPP intervention) conducted by two speech and language therapists in the home setting. Interventionists used video excerpts from previous video-recorded sessions of parent-child interactions 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 are at heightened risk, as each has an older sibling diagnosed with ASD.
Comparison conditions Comparison dyads received care as usual. However, all study participants were enrolled in the BASIS study and continued their study activities, including lab visits, as part of BASIS.
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).
Subgroups are not listed for manuscripts reviewed before 2021.
Staff characteristics and training Graduate speech and language therapists at each site conducted the iBASIS-VIPP intervention. The study assessed therapist fidelity to the manualized iBASIS-VIPP intervention in a subset of 15 participants and found that therapists demonstrated adequate fidelity in 22 of 23 sessions observed.
Funding sources This study was funded by Autistica, Waterloo Foundation, Autism Speaks, and the UK Medical Research Council.
Author affiliation The authors developed the iBASIS adaptation of the original VIPP intervention.
Peer reviewed Peer reviewed status is not listed for manuscripts reviewed before 2021.
Study Registration:

Clinicaltrials.gov Identifier: None found. Study registration was assessed by HomVEE beginning with the 2014 review.

Findings details

Child development and school readiness
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
High

Attention disengagement, measured by gap-overlap task

FavorableUnfavorable or ambiguousNo Effect

iBASIS-VIPP vs. usual care, London and Manchester

5 months

54 dyads Not reported Not reported Not reported Study reported = 0.48

Not statistically significant, p ≥ 0.05

High

Autism Observation Scale for Infants (AOSI) total score

FavorableUnfavorable or ambiguousNo Effect

iBASIS-VIPP vs. usual care, London and Manchester

5 months

54 dyads Not reported Not reported Not reported Study reported = 0.50

Not statistically significant, p ≥ 0.05

High

MacArthur-Bates Communicative Development Inventory (MCDI) expressive

FavorableUnfavorable or ambiguousNo Effect

iBASIS-VIPP vs. usual care, London and Manchester

5 months

52 dyads Not reported Not reported Not reported Study reported = -0.21

Not statistically significant, p ≥ 0.05

High

MacArthur-Bates Communicative Development Inventory (MCDI) receptiveness

FavorableUnfavorable or ambiguousNo Effect

iBASIS-VIPP vs. usual care, London and Manchester

5 months

51 dyads Not reported Not reported Not reported Study reported = -0.17

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, London and Manchester

5 months

54 dyads Not reported Not reported Not reported Study reported = 0.05

Not statistically significant, p ≥ 0.05

High

Manchester Assessment of Caregiver-Infant Interaction (MACI) Infant affect

FavorableUnfavorable or ambiguousNo Effect

iBASIS-VIPP vs. usual care, London and Manchester

5 months

54 dyads Not reported Not reported Not reported 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, London and Manchester

5 months

54 dyads Not reported Not reported Not reported Study reported = 0.29

Not statistically significant, p ≥ 0.05

High

Mullen Scales of Early Learning (MSEL) expressive score

FavorableUnfavorable or ambiguousNo Effect

iBASIS-VIPP vs. usual care, London and Manchester

5 months

54 dyads Not reported Not reported Not reported Study reported = -0.24

Not statistically significant, p ≥ 0.05

High

Mullen Scales of Early Learning (MSEL) receptive score

FavorableUnfavorable or ambiguousNo Effect

iBASIS-VIPP vs. usual care, London and Manchester

5 months

54 dyads Not reported Not reported Not reported Study reported = -0.42

Not statistically significant, p ≥ 0.05

High

Vineland Adaptive Behavior Scales (VABS-II) communication

FavorableUnfavorable or ambiguousNo Effect

iBASIS-VIPP vs. usual care, London and Manchester

5 months

52 dyads Not reported Not reported Not reported Study reported = -0.36

Not statistically significant, p ≥ 0.05

High

Vineland Adaptive Behavior Scales (VABS-II) socialization

FavorableUnfavorable or ambiguousNo Effect

iBASIS-VIPP vs. usual care, London and Manchester

5 months

49 dyads Not reported Not reported Not reported Study reported = 0.42

Not statistically significant, p ≥ 0.05

Positive parenting practices
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, London and Manchester

5 months

54 dyads Not reported Not reported Not reported 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, London and Manchester

5 months

54 dyads Not reported Not reported Not reported Study reported = -0.06

Not statistically significant, p ≥ 0.05

Outcome measure summary

Child development and school readiness
Outcome measure Description of measure Data collection method Properties of measure

Attention disengagement, measured by gap-overlap task

This measure uses computer eye-tracking equipment and software to measure saccadic reaction time when two objects are placed in an infant's view at different times.

Computer observation/measurement

Not reported by author.

Autism Observation Scale for Infants (AOSI) total score

The Autism Observation Scale for Infants (AOSI) is designed to detect early behavioral signs of autism in high-risk infants (those with an older sibling already diagnosed with autism spectrum disorder).

Trained observation

Not reported by author.

MacArthur-Bates Communicative Development Inventory (MCDI) expressive

The MacArthur-Bates Communicative Development Inventory (MCDI) is a parent-reported measure of early childhood vocabulary, language development, and non-verbal gestures.

Parent-report

Not reported by author.

MacArthur-Bates Communicative Development Inventory (MCDI) receptiveness

The MacArthur-Bates Communicative Development Inventory (MCDI) is a parent-reported measure of early childhood vocabulary, language development, and non-verbal gestures.

Parent-report

Not reported by author.

Manchester Assessment of Caregiver-Infant Interaction (MACI) Dyadic mutuality

The Manchester Assessment of Caregiver-Infant Interaction (MACI) is a collection of scales used to evaluate qualitative aspects of caregiver-child interaction observed in videotaped play.

Trained observation

Authors report this measure is validated and demonstrates high inter-rater agreement during the study.

Manchester Assessment of Caregiver-Infant Interaction (MACI) Infant affect

The Manchester Assessment of Caregiver-Infant Interaction (MACI) is a collection of scales used to evaluate qualitative aspects of caregiver-child interaction observed in videotaped play.

Trained observation

Authors report this measure is validated and demonstrates high inter-rater agreement during the study.

Manchester Assessment of Caregiver-Infant Interaction (MACI) Infant attentiveness

The Manchester Assessment of Caregiver-Infant Interaction (MACI) is a collection of scales used to evaluate qualitative aspects of caregiver-child interaction observed in videotaped play.

Trained observation

Authors report this measure is validated and demonstrates high inter-rater agreement during the study.

Mullen Scales of Early Learning (MSEL) expressive score

The Mullen Scales of Early Learning (MSEL) is a standardized assessment consisting of five scales, designed to measure motor, visual, and receptive skills in infants and young children.

Child assessment

Not reported by author.

Mullen Scales of Early Learning (MSEL) receptive score

The Mullen Scales of Early Learning (MSEL) is a standardized assessment consisting of five scales, designed to measure motor, visual, and receptive skills in infants and young children.

Child assessment

Not reported by author.

Vineland Adaptive Behavior Scales (VABS-II) communication

The Vineland Adaptive Behavior Scales II (VABS-II) is a set of standardized assessments used to diagnose and qualify behavioral or intellectual developmental disabilities.

Parent-report

Not reported by author.

Vineland Adaptive Behavior Scales (VABS-II) socialization

The Vineland Adaptive Behavior Scales II (VABS-II) is a set of standardized assessments used to diagnose and qualify behavioral or intellectual developmental disabilities.

Parent-report

Not reported by author.

Positive parenting practices
Outcome measure Description of measure Data collection method Properties of measure

Manchester Assessment of Caregiver-Infant Interaction (MACI) Caregiver non-directiveness

The Manchester Assessment of Caregiver-Infant Interaction (MACI) is a collection of scales used to evaluate qualitative aspects of caregiver-child interaction observed in videotaped play.

Trained observation

Authors report this measure is validated and demonstrates high inter-rater agreement during the study.

Manchester Assessment of Caregiver-Infant Interaction (MACI) Caregiver sensitive responding

The Manchester Assessment of Caregiver-Infant Interaction (MACI) is a collection of scales used to evaluate qualitative aspects of caregiver-child interaction observed in videotaped play.

Trained observation

Authors report this measure is validated and demonstrates high inter-rater agreement during the study.