Evaluation of the Social ABCs in Israel

NCT ID: NCT07025603

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Autism Spectrum Disorder (ASD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Social ABCs Program Participants

All participants will receive the Social ABCs program, a 6-week parent-mediated intervention. Each week includes one group session delivered via Zoom and one to two individual face-to-face coaching sessions with the parent and child. The program teaches parents strategies to support their child's social communication during everyday routines such as play, meals, and caregiving activities.

Group Type EXPERIMENTAL

The social ABCs

Intervention Type BEHAVIORAL

The Social ABCs, a parent-mediated intervention for toddlers with suspected or confirmed Autism Spectrum Disorder (ASD), originally developed in Canada (Brian et al., 2016). It is based on principles of Pivotal Response Treatment (PRT, grounded in Applied Behavioural Analysis). The two main goals of the intervention: early functional verbal communication and positive affect sharing in the context of play and caregiving activities.

The current study follows the Group Social ABCs protocol, a 6-week parent-mediated intervention designed to support early social communication in young children with autism. The program is delivered at two research sites: Soroka and Hebrew University of Jerusalem. Each week, parents participate in: One group session via Zoom, led by a trained Social ABCs coach, with 3-5 parents per group. These sessions introduce strategies and provide peer support, and one to two individual face-to-face coach (See #17-745 for more information).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The social ABCs

The Social ABCs, a parent-mediated intervention for toddlers with suspected or confirmed Autism Spectrum Disorder (ASD), originally developed in Canada (Brian et al., 2016). It is based on principles of Pivotal Response Treatment (PRT, grounded in Applied Behavioural Analysis). The two main goals of the intervention: early functional verbal communication and positive affect sharing in the context of play and caregiving activities.

The current study follows the Group Social ABCs protocol, a 6-week parent-mediated intervention designed to support early social communication in young children with autism. The program is delivered at two research sites: Soroka and Hebrew University of Jerusalem. Each week, parents participate in: One group session via Zoom, led by a trained Social ABCs coach, with 3-5 parents per group. These sessions introduce strategies and provide peer support, and one to two individual face-to-face coach (See #17-745 for more information).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

40 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ben-Gurion University of the Negev

OTHER

Sponsor Role collaborator

Soroka University Medical Center

OTHER

Sponsor Role collaborator

Azrieli National Centre for Autism and Neurodevelopment Disorders

UNKNOWN

Sponsor Role collaborator

Hebrew University of Jerusalem

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Judah Koller

Assistant Professor, Clinical Child Psychology and Special Education

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Judah Koller, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebrew University of Jerusalem

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Soroka Medical Center

Beersheba, , Israel

Site Status

Hebrew University of Jerusalem

Jerusalem, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol: HUJI

View Document

Document Type: Study Protocol: Soroka

View Document

Document Type: Informed Consent Form: HUJI

View Document

Document Type: Informed Consent Form: Soroka

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://clinicaltrials.gov/study/NCT03499262

Group Social ABCs Protocol on NIH website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SOR-20-0363

Identifier Type: OTHER

Identifier Source: secondary_id

2020Y1907

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.