NCT07025603

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

2.6 years

First QC Date

June 5, 2025

Last Update Submit

June 13, 2025

Conditions

Keywords

Social ABCsParent-mediatedinterventionNaturalistic Developmental Behavioral InterventionPivotal Response TreatmentEarly InterventionGroup InterventionSocial Communication

Outcome Measures

Primary Outcomes (3)

  • Feasibility and Acceptability of the Social ABCs Protocol

    Feasibility will be assessed by tracking recruitment rates, retention throughout the 6-week program, and attendance at both group and individual coaching sessions. Acceptability will be evaluated through parent-reported satisfaction surveys completed at the end of the program, as well as qualitative feedback on the format, content, and delivery of the intervention.

    immediately after the intervention

  • The Hebrew Communicative Development Inventory (HCDI).

    The HCDI is the adapted Hebrew version of the MacArthur Communicative Development Inventory (MCDI). The MCDI is a well normed, reliable, and valid tool for vocabulary assessment (Bates et al., 1994). The HCDI is a reliable and sensitive measure of lexical development and emergent grammar, capturing wide variability among Israeli toddlers (Maital et al., 2000). We utilized two versions of the inventory: Words \& Gestures for toddlers up to 25 months and Words \& Sentences for children 25 months and older. This questionnaire relies on caregiver report to assess children's receptive and expressive vocabulary, speech comprehension, gesture use, morpheme acquisition, and syntactic complexity. In our study, we focused on two variables: receptive vocabulary total score and expressive vocabulary total score

    Baseline (pre-intervention); 6 weeks post-intervention

  • Parenting Stress Index Short Form (PSI-SR).

    The PSI-SR is a self-report, 36-item index of parenting-related stress. Each item is scored on a 5-point Likert-type scale, with higher scores indicating greater parenting stress (range 36-180). Alongside a total stress score, the three subscale scores are derived, each composed of 12 items (range 12-60): parental distress (PD), measuring distress caused by the burdens and restrictions of childcare and personal stressors (e.g., depression, conflict with partner); parent-child dysfunctional interaction (PCDI), assessing parents' negative perception of their interactions with the child and the degree to which the child does not meet their expectations; and difficult child (DC), measuring parents' views of the child's self-regulatory functioning. It also includes a defensive responding scale (DR; seven items, range 7-35), which assesses if the parent is trying to deny or minimize problems.

    Baseline (pre-intervention); 6 weeks post-intervention

Secondary Outcomes (6)

  • Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2; Lord et al., 2012).

    Baseline (pre-intervention); 6 weeks post-intervention

  • The Mullen Scales of Early Learning (MSEL; Mullen, 1995).

    Baseline (pre-intervention); 6 weeks post-intervention

  • Adaptive Behavior Assessment System-Second Edition Parent Form, Ages 0-5 (ABAS-II; Harrison & Oakland, 2000).

    Baseline (pre-intervention); 6 weeks post-intervention

  • Aberrant Behavior Checklist (ABC; Aman et al., 1985; Kaat et al., 2014).

    Baseline (pre-intervention); 6 weeks post-intervention

  • Communication and Symbolic Behavior Scales Developmental Profile (CSBS-DP) Infant-Toddler Checklist

    Baseline (pre-intervention); 6 weeks post-intervention

  • +1 more secondary outcomes

Study Arms (1)

Social ABCs Program Participants

EXPERIMENTAL

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.

Behavioral: The social ABCs

Interventions

The social ABCsBEHAVIORAL

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).

Social ABCs Program Participants

Eligibility Criteria

Age12 Months - 40 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Soroka Medical Center

Beersheba, Israel

Location

Hebrew University of Jerusalem

Jerusalem, Israel

Location

Related Links

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum DisorderCommunication

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Judah Koller, PhD

    Hebrew University of Jerusalem

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Clinical Child Psychology and Special Education

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 17, 2025

Study Start

June 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations