Multicentre, randomized controlled trial of the Frankfurt Early Intervention Program for tod-dlers and preschool children with Autism Spectrum Disorder – A-FFIP

Multicentre, randomized controlled trial of the Frankfurt Early Intervention Program for tod-dlers and preschool children with Autism Spectrum Disorder – A-FFIP - A-FFIP

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016330

Enrollment

134

Registered

2019-01-04

Start date

2018-07-03

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DSM-5: 299.0 Autism Spectrum Disorder F84.0 F84.5

Interventions

Group 1: Autism-specific early intervention according to the A-FFIP manual (Teufel et al., 2017) Group 2: Early intervention as usual

Eligibility

Sex/Gender

All

Age

24 Months to 66 Months

Inclusion criteria

Inclusion criteria: Autism Spectrum Disorder according to DSM-5

Exclusion criteria

Exclusion criteria: Key exclusion criteria: non-verbal IQ/DQ <= 30, non-verbal mental age < =12 months, sensory impairments, cerebral palsy, chronic neurological disorder, unstable epilepsy, neurodegenerative disorder, Rett / Angelman Syndrome, severe psychosocial deprivation, insufficient care by parents, attachment disorder, institutional upbringing, parents not verbally fluent in German and/or unable to read German. Amendment from October 16, 2018: A correction of the key exclusion criteria from non-verbal IQ/DQ <40, non-verbal mental age < 15 months to non-verbal IQ/DQ <= 30, non-verbal mental age < =12 months was submitted. The ethics commission accepted this on January 24, 2019.

Design outcomes

Primary

Measure	Time frame
Absolute change in the total score of the Brief Observation of Social Communication Change (BOSCC-AT) between baseline and 12 months after the first intervention session.	—

Secondary

Measure	Time frame
Key secondary endpoint(s): Child outcomes: change in BOSCC social communication and repetitive behaviour subscales, BOSCC single items; cognition and language (Bayley-III, WPPSI-III), psychopathology (parents, kindergarten teachers: SRS, RBS-R; CBCL1½-5, C-TRF, BRIEF-P); parent outcomes: change in parenting abilities; parental stress, depression and anxiety symptoms; family outcomes: family quality of life (FQOLS-2006 ID/DD). Assessment of safety: (Serious) adverse events will be documented. Predictors and moderators (exploratory): Child: Baseline IQ/DQ, sex, age, severity of autistic symptoms (BOSCC), social orienting (eye-tracking measures, Frankfurt subgroup only); Parents: educational status. Mediating mechanisms (exploratory): Child: joint attention, social interaction (ESCS), cognitive and fine-motor skills (Bayley-III); Parents: parental synchrony (DCMA); parent’s adherence and competence of intervention strategy use at home.	—

Measure

Time frame

Key secondary endpoint(s): Child outcomes: change in BOSCC social communication and repetitive behaviour subscales, BOSCC single items; cognition and language (Bayley-III, WPPSI-III), psychopathology (parents, kindergarten teachers: SRS, RBS-R; CBCL1½-5, C-TRF, BRIEF-P); parent outcomes: change in parenting abilities; parental stress, depression and anxiety symptoms; family outcomes: family quality of life (FQOLS-2006 ID/DD). Assessment of safety: (Serious) adverse events will be documented. Predictors and moderators (exploratory): Child: Baseline IQ/DQ, sex, age, severity of autistic symptoms (BOSCC), social orienting (eye-tracking measures, Frankfurt subgroup only); Parents: educational status. Mediating mechanisms (exploratory): Child: joint attention, social interaction (ESCS), cognitive and fine-motor skills (Bayley-III); Parents: parental synchrony (DCMA); parent’s adherence and competence of intervention strategy use at home.

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Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 28, 2026