Complex, low-intensity, individualised naturalistic developmental behavioural intervention in toddlers and
Christine M Freitag1, Marietta Kirchner2, Lukas D Sauer2
1Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Autism Research and Intervention Centre of Excellence, University Hospital Frankfurt, Goethe-University, Frankfurt am Main, Germany.
Insights
The Frankfurt Early Intervention Program for Autism Spectrum Disorder (A-FFIP) did not significantly improve social communication in young children with ASD compared to usual care. However, A-FFIP showed potential benefits in reducing repetitive behaviors and enhancing executive functions.
Area of Science:
- Developmental Psychology
- Clinical Psychology
- Neurodevelopmental Disorders
Background:
- Naturalistic Developmental Behavioral Interventions (NDBI) show promise for improving social communication in toddlers and preschoolers with Autism Spectrum Disorder (ASD).
- The Frankfurt Early Intervention Program for ASD (A-FFIP) is a low-intensity, complex NDBI designed to target core developmental domains in children with ASD.
Purpose of the Study:
- To evaluate the efficacy of the A-FFIP intervention over one year in improving social communication in children with ASD.
- To compare A-FFIP to Early Intervention as Usual (EIAU) in a phase-III, randomized controlled trial.
Main Methods:
- A prospective, randomized, controlled, parallel-group study involving 134 children aged 24-66 months diagnosed with ASD.
- Participants were allocated to either the manualized A-FFIP intervention or EIAU.
- The primary outcome was the change in core ASD symptoms, measured by the Brief Observation for Communication Change (BOSCC) total score, from baseline to 12 months.
Main Results:
- The study found no significant difference in the primary outcome (social communication) between the A-FFIP and EIAU groups.
- The SARS-CoV-2 pandemic significantly impacted trial procedures and led to reduced improvements across both groups.
- Secondary analyses indicated improvements in parent-rated repetitive behavior and parent- and teacher-rated executive functions for the A-FFIP group.
Conclusions:
- The A-FFIP program did not demonstrate superiority over EIAU in improving social communication, cognitive, or behavioral outcomes in children with ASD after one year.
- A-FFIP may offer benefits in addressing repetitive behaviors and executive functions in this population.
- Further research is needed to explore the specific components of A-FFIP that may contribute to these observed secondary benefits.
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.
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