Evidence map›Paper›PMID 26359749›Full record

Trial reportThe lancet. Psychiatry2015

Parent-mediated intervention versus no intervention for infants at high risk of autism: a parallel, single-blind, randomised trial.

Jonathan Green, Tony Charman, Andrew Pickles, Ming W Wan, Mayada Elsabbagh, Vicky Slonims, Carol Taylor, Janet McNally, Rhonda Booth, Teodora Gliga and 5 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The lancet. Psychiatry, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06512649 (Early Recognition and Intervention in Siblings at High-risk for Neurodevelopmental Disorder), which is not on this map. Cited by 115 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
115citing papers in PubMed, 12 pooled it
14.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06512649 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Early Recognition and Intervention in Siblings at High-risk for Neurodevelopmental Disorder

TypeinterventionalSponsorFondazione Don Carlo Gnocchi ETSRan2023 to 2026Enrolled48ConditionsNeurodevelopmental Disorders, Autism Spectrum DisorderArmsEarly intervention, Active monitoring
3 · Its place in the literature

Who cites it

115 citing papers in PubMed, 12 syntheses or guidelines pooled it, 263 citations in OpenAlex.

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55 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 5 institutions in 3 countries.

Jonathan GreenInstitute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK. Electronic address: jonathan.green@manchester.ac.uk.
Tony CharmanInstitute of Psychiatry, Psychology and Neuroscience, King's College London, Department of Psychology, London, UK.
Andrew PicklesInstitute of Psychiatry, Psychology and Neuroscience, King's College London, Department of Psychology, London, UK; National Institute for Health Research Mental Health Biomedical Research Centre, South London and Maudsley NHS Foundation Trust, London, UK.
Ming W WanInstitute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK.
Mayada ElsabbaghCentre for Brain and Cognitive Development, Birkbeck College, London, UK; Department of Psychiatry, McGill University, West Montreal, QC, Canada.
Vicky SlonimsEvelina London Children's Hospital and Kings College London Neurosciences Centre, London, UK.
Carol TaylorInstitute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK.
Janet McNallyInstitute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK; Institute of Psychological Sciences, University of Leeds, Leeds, UK.
Rhonda BoothInstitute of Child Health, University College London, London, UK.
Teodora GligaCentre for Brain and Cognitive Development, Birkbeck College, London, UK.
Emily J H JonesCentre for Brain and Cognitive Development, Birkbeck College, London, UK.
Clare HarropInstitute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK; Kasari Lab, UCLA Center for Autism Research and Treatment, Semel Institute, Los Angeles, CA, USA.
Rachael BedfordInstitute of Psychiatry, Psychology and Neuroscience, King's College London, Department of Psychology, London, UK.
Mark H JohnsonCentre for Brain and Cognitive Development, Birkbeck College, London, UK.
BASIS team
University of Manchester · GBBirkbeck, University of London · GBKing's College London · GBEvelina London Children's Healthcare · GBUniversity College London · GB

Funding

Medical Research Council G0600977Medical Research Council G0701484Medical Research Council MR/K021389/1
6 · The paper itself

Abstract

backgroundRisk markers for later autism identified in the first year of life present plausible intervention targets during early development. We aimed to assess the effect of a parent-mediated intervention for infants at high risk of autism on these markers.

methodsWe did a two-site, two-arm assessor-blinded randomised controlled trial of families with an infant at familial high risk of autism aged 7-10 months, testing the adapted Video Interaction to Promote Positive Parenting (iBASIS-VIPP) versus no intervention. Families were randomly assigned to intervention or no intervention groups using a permuted block approach stratified by centre. Assessors, but not families or therapists, were masked to group assignment. The primary outcome was infant attentiveness to parent. Regression analysis was done on an intention-to-treat basis. This trial is registered with ISCRTN Registry, number ISRCTN87373263.

findingsWe randomly assigned 54 families between April 11, 2011, and Dec 4, 2012 (28 to intervention, 26 to no intervention). Although CIs sometimes include the null, point estimates suggest that the intervention increased the primary outcome of infant attentiveness to parent (effect size 0.29, 95% CI -0.26 to 0.86, thus including possibilities ranging from a small negative treatment effect to a strongly positive treatment effect). For secondary outcomes, the intervention reduced autism-risk behaviours (0.50, CI -0.15 to 1.08), increased parental non-directiveness (0.81, 0.28 to 1.52), improved attention disengagement (0.48, -0.01 to 1.02), and improved parent-rated infant adaptive function (χ(2)[2] 15.39, p=0.0005). There was a possibility of nil or negative effect in language and responsivity to vowel change (P1: ES-0.62, CI -2.42 to 0.31; P2: -0.29, -1.55 to 0.71).

interpretationWith the exception of the response to vowel change, our study showed positive estimates across a wide range of behavioural and brain function risk-markers and developmental outcomes that are consistent with a moderate intervention effect to reduce the risk for later autism. However, the estimates have wide CIs that include possible nil or small negative effects. The results are encouraging for development and prevention science, but need larger-scale replication to improve precision.

fundingAutistica, Waterloo Foundation, Autism Speaks, and the UK Medical Research Council.

Indexed as

Parent-Child RelationsAutistic DisorderFemaleHumansInfantMaleParentingParentsRisk AssessmentSingle-Blind MethodTreatment OutcomeVideotape Recording

Identifiers

PMID26359749
PMCPMC4722333
OpenAlexW2106155621

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.