Trial reportJournal of child psychology and psychiatry, and allied disciplines2025
Complex, low-intensity, individualised naturalistic developmental behavioural intervention in toddlers and pre-schoolers with autism spectrum disorder: The multicentre, observer-blind, parallel-group randomised-controlled A-FFIP trial.
Trial report in Journal of child psychology and psychiatry, and allied disciplines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Rapid Review of the Brief Observation of Social Communication Change (BOSCC) Shows It Can Detect Behavioural Changes in Social Communication in Autism.Autism : the international journal of research and practice · 2026Pooled it
- Transcranial Direct Current Stimulation of the Temporoparietal Junction in Autism Spectrum Disorder: Results of a Phase-IIa Randomized, Double-Blind, Sham-Controlled Feasibility Study.Autism research : official journal of the International Society for Autism Research · 2025Trial
- Psychological Interventions for Children with Neurodevelopmental Disabilities in the Context of Neurodiversity: A Systematic Review.Children (Basel, Switzerland) · 2026Review
- Visual Search Performance in Children With ASD: A Combined Case-Control and Longitudinal Study.Autism research : official journal of the International Society for Autism Research · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
Abstract
backgroundNaturalistic developmental behavioural interventions (NDBI) may improve social communication in toddlers/pre-school aged children with autism spectrum disorder (ASD). Here, we study efficacy of the low-intensity, complex NDBI 'Frankfurt Early Intervention Program for ASD' (A-FFIP) over 1 year by a confirmatory phase-III, prospective, randomised, controlled, parallel-group study with two treatment arms over four centres.
methodsMain inclusion criteria: ASD (DSM-5), age 24-66 months, developmental quotient >30.
interventionManualised A-FFIP intervention. Control intervention: Early intervention as usual (EIAU). PRIMARY OUTCOME: Change in core ASD symptoms from baseline (T2) to immediate intervention endpoint at 12 months (T6) based on the blindly rated Brief Observation for Communication Change (BOSCC) total score. STATISTICAL ANALYSIS: Mixed model for repeated measures with covariates baseline BOSCC-total, chronological age and centre.
resultsBetween July 2018 and October 2021, N = 134 children with ASD were randomly allocated to intervention (A-FFIP: n = 68, EIAU: n = 66). Groups did not differ at baseline, with a mean age of 49 (SD 10) months, a mean developmental age of 23.3 (SD 13.6) months and 26 (19.4%) females. The SARS-CoV-2 pandemic interfered severely with trial procedures. Intention-to-treat analysis in the primary analysis set, with at least one postbaseline BOSCC measure (A-FFIP n = 64, EIAU n = 60), did not find differences in the primary outcome by group (adjusted ES -0.06, 95% CI to -0.24 to 0.11). SARS-CoV2-related lockdown led to less improvement across groups. Secondary outcomes showed stronger improvements in parent-rated repetitive behaviour as well as parent- and teacher-rated executive functions for A-FFIP versus EIAU. Adverse events were comparable between groups.
conclusionsThe manualised NDBI program A-FFIP, which allows individually targeting six core basic abilities and five developmental domains related to longitudinal development in ASD, did not improve social communication, cognitive or behavioural outcomes beyond EIAU after 1 year, but may improve repetitive behaviour and executive function.
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