Christine M Freitag, Marietta Kirchner, Lukas D Sauer, Solveig K Kleber, Leonie Polzer, Naisan Raji, Christian Lemler, Ulrike Fröhlich, Tomasz Jarczok, Julia Geissler, Franziska Radtke, Melanie Ring, Veit Roessner, Regina Taurines, Michelle Noterdaeme, Karoline Teufel, Ziyon Kim, Janina Kitzerow-Cleven
{"title":"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.","authors":"Christine M Freitag, Marietta Kirchner, Lukas D Sauer, Solveig K Kleber, Leonie Polzer, Naisan Raji, Christian Lemler, Ulrike Fröhlich, Tomasz Jarczok, Julia Geissler, Franziska Radtke, Melanie Ring, Veit Roessner, Regina Taurines, Michelle Noterdaeme, Karoline Teufel, Ziyon Kim, Janina Kitzerow-Cleven","doi":"10.1111/jcpp.14162","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Naturalistic 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.</p><p><strong>Methods: </strong>Main inclusion criteria: ASD (DSM-5), age 24-66 months, developmental quotient >30.</p><p><strong>Intervention: </strong>Manualised A-FFIP intervention. Control intervention: Early intervention as usual (EIAU).</p><p><strong>Primary outcome: </strong>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.</p><p><strong>Statistical analysis: </strong>Mixed model for repeated measures with covariates baseline BOSCC-total, chronological age and centre.</p><p><strong>Results: </strong>Between 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.</p><p><strong>Conclusions: </strong>The 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.</p>","PeriodicalId":187,"journal":{"name":"Journal of Child Psychology and Psychiatry","volume":" ","pages":""},"PeriodicalIF":6.5000,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Child Psychology and Psychiatry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/jcpp.14162","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PSYCHIATRY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Naturalistic 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.
Methods: Main inclusion criteria: ASD (DSM-5), age 24-66 months, developmental quotient >30.
Intervention: Manualised 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.
Results: Between 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.
Conclusions: The 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.
期刊介绍：
The Journal of Child Psychology and Psychiatry (JCPP) is a highly regarded international publication that focuses on the fields of child and adolescent psychology and psychiatry. It is recognized for publishing top-tier, clinically relevant research across various disciplines related to these areas. JCPP has a broad global readership and covers a diverse range of topics, including:
Epidemiology: Studies on the prevalence and distribution of mental health issues in children and adolescents.
Diagnosis: Research on the identification and classification of childhood disorders.
Treatments: Psychotherapeutic and psychopharmacological interventions for child and adolescent mental health.
Behavior and Cognition: Studies on the behavioral and cognitive aspects of childhood disorders.
Neuroscience and Neurobiology: Research on the neural and biological underpinnings of child mental health.
Genetics: Genetic factors contributing to the development of childhood disorders.
JCPP serves as a platform for integrating empirical research, clinical studies, and high-quality reviews from diverse perspectives, theoretical viewpoints, and disciplines. This interdisciplinary approach is a key feature of the journal, as it fosters a comprehensive understanding of child and adolescent mental health.
The Journal of Child Psychology and Psychiatry is published 12 times a year and is affiliated with the Association for Child and Adolescent Mental Health (ACAMH), which supports the journal's mission to advance knowledge and practice in the field of child and adolescent mental health.
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