Multicentre, randomized controlled trial of the Frankfurt Early Intervention Program for toddlers and preschool aged children with Autism Spectrum Disorder - ASD-FFIP-net
Final Report Abstract
With this project we aimed at showing efficacy of the naturalistic developmentally based behavioural intervention approach A-FFIP compared to early intervention / treatement as usual (EIAU). A-FFIP was developed as low intensity complex early intervention within the German social welfare system (“Frühförderung”, according to SGB IX), according to the current state of research in ASD. A broad range of primary and secondary outcomes related to the child and her/his family as well as possible moderating and mediating factors were collected. Preliminary, first results do not show differences in change of core ASD symptoms, measured by the blinded BOSCC total (obtained from play with an unknown observer) between A-FFIP and EIAU. Some secondary outcomes, such as parent rated core ASD symptoms (unblinded) as well as language development show a stronger improvement in A-FFIP the EIAU. Additional statistics, moderation and mediation analyses are pending. In addition, we collected a broad range of data on training and manual adherence of the therapists, intervention adherence by the parents, and showed, that the intervention can be implemented within the German health care sector (Frühförderzentrum or psychiatrische Instituts-ambulanz), serving the community. The majority of the included children came from families with at least one parent having imigrated to Germany as an adult; thus, within the study we were able to serve a diverse population, representative of German cities. Therefore, the study will also allow to gradually improving community care for toddlers and preschool children in Germany. An unexpected challenge was the SARS-CoV2 pandemic, which emerged in the course of recruitment. Due to the pandemic, the actual time intervals between visits varied more than expected. In addition, study and interventions had to be continued under different conditions as before. During the pandemic, the therapists had to wear a facemask during intervention, and the testers also had to wear it during the testings for the primary outcome measure. The statistical analysis has been adapted in order to take some of these aspects into account. Still, we cannot fully exclude an influence of the SARS-CoV2-related mitigation measures (staying at home, wearing facemasks etc.) on the study outomes, either due to effects on intervention or on outcome measures. Still, the current sample provides the basis for further longitudinal studies and analyses of early development in ASD.
Publications
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Study protocol of the multi-centre, randomised controlled trial of the Frankfurt Early Intervention Programme A-FFIP versus early intervention as usual for toddlers and preschool children with Autism Spectrum Disorder (A-FFIP study). Trials, 21(1).
Kitzerow, Janina; Hackbusch, Matthes; Jensen, Katrin; Kieser, Meinhard; Noterdaeme, Michele; Fröhlich, Ulrike; Taurines, Regina; Geißler, Julia; Wolff, Nicole; Roessner, Veit; Bast, Nico; Teufel, Karoline; Kim, Ziyon & Freitag, Christine M.
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19th International Congress of the European Society for Child and Adolescent Psychiatry (ES- CAP) 2022 Types of natural re-inforcement in the A-FFIP intervention and their relation to the child’s characteristics
Freitag C.M.
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Pupillometric measures of altered stimulus‐evoked locus coeruleus‐norepinephrine activity explain attenuated social attention in preschoolers with autism spectrum disorder. Autism Research, 15(11), 2167-2180.
Polzer, Leonie; Freitag, Christine M. & Bast, Nico
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20th International Congress of the European Society for Child and Adolescent Psychiatry (ES- CAP) 2023 First results of the Multicentre, randomized controlled trial of the Frankfurt Early Intervention Program for toddlers and preschool children with Autism Spectrum Disorder - A-FFIP
Freitag, C.M.; Kirchner, M.; Kleber, S.; Polzer, L.; Raji, N.; Albertowski, K.; Taurines, R.; Fröhlich, U.; Kitzerow, J. & Kim, Z.
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20th International Congress of the European Society for Child and Adolescent Psychiatry (ES- CAP) 2023 Naturalistic developmental behavioral intervention (NDBI) might improve joint attention and associated neurophysiological reactivity in preschoolers with autism spectrum condition
Bast, N.; Polzer, L.; Raji, N.; Kleber, S.; Lemler, C.; Kitzerow, J.; Kim, Z. & Freitag, C.M.
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22nd International Society for Autism (INSAR) Annual meeting 2023. Naturalistic Developmental Behavioral Intervention (NDBI) Might Improve Joint Attention and Associated Neurophysiological Reactivity in Preschoolers with Autism Spectrum Condition
Bast, N.; Polzer, L.; Raji, N.; Kleber, S. K.; Lemler, C.; Kitzerow-Cleven, J. [...] & Freitag, C. M.
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Naturalistic developmental behavioral intervention (NDBI) might improve joint attention and associated neurophysiological reactivity in preschoolers with autism spectrum condition. 14. Wissenschaftliche Tagung Autismus-Spektrum (WTAS) 2023
Bast, N.; Polzer, L.; Raji, N.; Kleber, S.; Lemler, C.; Kitzerow, J.; Kim, Z. & Freitag, C.M.
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Positive Verstärkung im Interventionsverlauf – Zusammenhänge von Kind Charakteristika und positiven Verstärkungssituationen während der A-FFIP Therapie .14. Wissenschaftliche Tagung Autismus-Spektrum (WTAS) 2023
Kleber, S. et al.
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Pupillenreaktionen zeigen eine verringerte physiologische Aktivierung während kognitiver Verarbeitung emotionaler Gesichtsausdrücke bei ASS 14. Wissenschaftliche Tagung Autismus-Spektrum (WTAS) 2023
Polzer, L. et al.
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Veränderung der Symptomschwere von restriktiven und repetitiven Verhaltensweisen bei Vorschulkindern mit ASS: Eine Untersuchung der Veränderungssensitivität von RBS-R, ADOS-2 und BOSCC 14. Wissenschaftliche Tagung Autismus-Spektrum (WTAS) 2023
Raji, N. et al.
