Clinical trial NCT07025603: Evaluation of the Social ABCs in Israel
Official title: Pilot Evaluation of the Social ABCs Parent-Mediated Intervention for Autistic Toddlers in Israel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Autism Spectrum Disorder (ASD)
Keywords: Social ABCs
Parent-mediated
intervention
Naturalistic Developmental Behavioral Intervention
Pivotal Response Treatment
Early Intervention
Group Intervention
Social Communication
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
name: Soroka University Medical Center
name: Azrieli National Centre for Autism and Neurodevelopment Disorders
First posted: 2025-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the effectiveness of the Social ABCs program for young autistic children and their parents. The study will also explore predictors of treatment success and child outcomes.

The main questions it aims to answer are:

* Does the Social ABCs program help children use more words and communicate better?
* Does the program help parents feel more confident and less stressed?
* Which children and parents benefit most from the program?

Participants will:

* Join a 6-week Social ABCs program with weekly group and individual coaching sessions
* Complete assessments before and after the program to see how their child and family are doing
* Take part in short video-recorded play sessions to see how communication changes over time


Eligibility criteria: Inclusion Criteria:

* children who met diagnostic criteria for autism according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), established by independent gold-standard assessments by both a psychologist and a physician (i.e., child psychiatrist, developmental pediatrician, or child neurologist)
* diagnosis received before 30 months of age.
* full-term birth (36-42 weeks gestation) with birth weight \>2500 grams

Exclusion Criteria:

* identifiable neurological, genetic, or severe sensory/motor conditions
* attending a special education kindergarten
* participating in a concurrent parent-mediated intervention.

Primary outcomes:
measure: Feasibility and Acceptability of the Social ABCs Protocol
timeFrame: immediately after the intervention
measure: The Hebrew Communicative Development Inventory (HCDI).
timeFrame: Baseline (pre-intervention); 6 weeks post-intervention
measure: Parenting Stress Index Short Form (PSI-SR).
timeFrame: Baseline (pre-intervention); 6 weeks post-intervention
Secondary outcomes:
measure: Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2; Lord et al., 2012).
timeFrame: Baseline (pre-intervention); 6 weeks post-intervention
measure: The Mullen Scales of Early Learning (MSEL; Mullen, 1995).
timeFrame: Baseline (pre-intervention); 6 weeks post-intervention
measure: Adaptive Behavior Assessment System-Second Edition Parent Form, Ages 0-5 (ABAS-II; Harrison & Oakland, 2000).
timeFrame: Baseline (pre-intervention); 6 weeks post-intervention
measure: Aberrant Behavior Checklist (ABC; Aman et al., 1985; Kaat et al., 2014).
timeFrame: Baseline (pre-intervention); 6 weeks post-intervention
measure: Communication and Symbolic Behavior Scales Developmental Profile (CSBS-DP) Infant-Toddler Checklist
timeFrame: Baseline (pre-intervention); 6 weeks post-intervention
measure: Social ABCs Satisfaction Questionnaire (Brian et al., 2016).
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Jerusalem
country: Israel
facility: Hebrew University of Jerusalem
Study officials:
affiliation: Hebrew University of Jerusalem
name: Judah Koller, PhD
role: PRINCIPAL_INVESTIGATOR
References: