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.

IF 6.5 1区 医学 Q1 PSYCHIATRY
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
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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.

复杂的,低强度的,个性化的自然发展行为干预幼儿和学龄前自闭症谱系障碍:多中心,观察者盲,平行组随机对照A-FFIP试验。
背景:自然发展行为干预(NDBI)可以改善幼儿/学龄前自闭症谱系障碍(ASD)儿童的社会沟通。在这里,我们研究了低强度,复杂的NDBI“法兰克福ASD早期干预计划”(a - ffip)超过1年的疗效,通过一个验证性的iii期,前瞻性,随机,对照,平行组研究,在四个中心的两个治疗组。方法:主要纳入标准:ASD (DSM-5),年龄24-66月龄,发育商bbb30。干预:手动A-FFIP干预。对照干预:早期照例干预(EIAU)。主要结局:基于盲目评分的交流变化简短观察(BOSCC)总分,核心ASD症状从基线(T2)到12个月时立即干预终点(T6)的变化。统计分析:用协变量基线BOSCC-total、实足年龄和中心进行重复测量的混合模型。结果:在2018年7月至2021年10月期间,N = 134名ASD儿童被随机分配到干预组(A-FFIP: N = 68, EIAU: N = 66)。各组在基线时没有差异,平均年龄为49 (SD 10)个月,平均发育年龄为23.3 (SD 13.6)个月,女性26(19.4%)。SARS-CoV-2大流行严重干扰了试验程序。在主要分析集中,至少有一个基线后BOSCC测量(A-FFIP n = 64, EIAU n = 60)的意向治疗分析未发现各组主要结局的差异(调整后ES为-0.06,95% CI为-0.24至0.11)。与sars - cov2相关的封锁导致各组之间的改善较小。次要结果显示,与EIAU相比,A-FFIP在家长评价的重复行为以及家长和教师评价的执行功能方面有更大的改善。两组间不良事件具有可比性。结论:手动NDBI计划A-FFIP,允许单独针对6个核心基本能力和5个与ASD纵向发展相关的发展领域,并没有改善1年后的社会沟通、认知或行为结果,但可能改善重复行为和执行功能。
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来源期刊
CiteScore
13.80
自引率
5.30%
发文量
169
审稿时长
1 months
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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