AutismNCT07025603
Evaluation of the Social ABCs in Israel
A study testing The social ABCs in people with Autism and Autism Spectrum Disorder (ASD), run by Hebrew University of Jerusalem at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 40 months
- Conditions the study is for
- Autism, Autism Spectrum Disorder (ASD)
- What is being tested?
- The social ABCs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Jun 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- identifiable neurological, genetic, or severe sensory/motor conditions
- attending a special education kindergarten
- participating in a concurrent parent-mediated intervention.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Soroka Medical Center
Beersheba
Hebrew University of Jerusalem
Jerusalem
About this study
Official title: Pilot Evaluation of the Social ABCs Parent-Mediated Intervention for Autistic Toddlers in Israel
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:
Read more
- 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
- Conditions
- Autism, Autism Spectrum Disorder (ASD)
- Being tested
- The social ABCs
- Keywords
- Social ABCs, Parent-mediated, intervention, Naturalistic Developmental Behavioral Intervention, Pivotal Response Treatment, Early Intervention, Group Intervention, Social Communication
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The social ABCsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The social ABCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Baseline (pre-intervention); 6 weeks post-intervention
Secondary outcomes (6)
Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2; Lord et al., 2012).
This is a semi-structured, standardized behavioral assessment of social communication abilities and restricted and repetitive behaviors. We used the ADOS-2 calibrated severity scores (CSS) to estimate autism symptom severity while separating CSS into the Social Affect (SA) and the Restricted and Repetitive Behavior (RRB) domains. The CSS were specifically developed to enable comparison of autism severity independent of the child's age and language abilities (Hus et al., 2014).
Verbal ability was evaluated using item A1 of the ADOS-2
Measured: Baseline (pre-intervention); 6 weeks post-intervention
The Mullen Scales of Early Learning (MSEL; Mullen, 1995).
The MSEL is a standardized developmental assessment that quantifies expressive and receptive language, motor, perceptual abilities, and motor development. All MSEL were administered and/or supervised by licensed developmental psychologists.
Measured: Baseline (pre-intervention); 6 weeks post-intervention
Adaptive Behavior Assessment System-Second Edition Parent Form, Ages 0-5 (ABAS-II; Harrison & Oakland, 2000).
The ABAS-II Parent Form (ages 0-5) is a comprehensive norm-referenced parent-report rating scale used for measuring adaptive behaviors and skills in children on a 4-point Likert-type scale, with higher scores indicating better adaptive functioning. The ten skills of the ABAS-II are combined into a general adaptive behavior composite score (GAC) and three composites: conceptual (communication, functional pre-academics, and self-direction), social (social skills and leisure), and practical (self-care, home living, community use, health and safety).
Measured: Baseline (pre-intervention); 6 weeks post-intervention
Aberrant Behavior Checklist (ABC; Aman et al., 1985; Kaat et al., 2014).
The ABC is a caregiver-report measure of disruptive behaviors with 58 items, each rated on a four-point Likert-type scale (0-3), with higher scores indicative of more severe problematic behavior, on five subscales: Irritability (tantrums, aggression and self-injury, 15 items); Social Withdrawal (16 items); Stereotypic Behavior (7 items); Hyperactivity/Noncompliance (16 items); and Inappropriate Speech (4 items). In autistic children, the ABC subscales demonstrate adequate convergent validity (Kaat et al., 2014), however the scale does not have Israeli norms.
Measured: Baseline (pre-intervention); 6 weeks post-intervention
Communication and Symbolic Behavior Scales Developmental Profile (CSBS-DP) Infant-Toddler Checklist
The CSBS-DP Infant-Toddler Checklist is a screening tool designed to determine whether a full developmental evaluation is warranted. It is a parent-report measure, consisting of 24 items that range from a possible of two to four points within each of seven clusters. Scores are given for three composites: Social Composite (Emotion, Eye Gaze, Communication and Gestures Clusters); Speech Composite (Sounds and Words Clusters); Symbolic Composite (Understanding and Object Use Clusters). Norms of the CSBS-DP are available only up to 24 months, so we used the raw scores
Measured: Baseline (pre-intervention); 6 weeks post-intervention
Social ABCs Satisfaction Questionnaire (Brian et al., 2016).
This is a 7-item questionnaire where parents reported whether the intervention was "helpful" in different domains. Ratings were completed using a 5-point scale (1: "not at all helpful" to 5: "extremely helpful").
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jun 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev, Soroka University Medical Center, Azrieli National Centre for Autism and Neurodevelopment Disorders
- Responsible party
- Principal investigator, Judah Koller, Hebrew University of Jerusalem
- Investigators
- Judah Koller, PhD, Principal investigator, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025603
- Sponsor's protocol ID
- 2020Y1907
- Other IDs
- SOR-20-0363
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the Social ABCs Parent-Mediated Intervention for Autistic Toddlers in Israel
- ClinicalTrials.gov ID
- NCT07025603
- Acronym / sponsor ID
- 2020Y1907
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev, Soroka University Medical Center, Azrieli National Centre for Autism and Neurodevelopment Disorders
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social ABCs Program Participants | Experimental | Behavioral: The social ABCsAll 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. |
Who may qualify
- Ages
- 12 to 40 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- identifiable neurological, genetic, or severe sensory/motor conditions
- attending a special education kindergarten
- participating in a concurrent parent-mediated intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The social ABCsThe 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). | Behavioural | Social ABCs Program Participants |
Primary outcome
Feasibility and Acceptability of the Social ABCs Protocol
Time frame: immediately after the intervention
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.
The Hebrew Communicative Development Inventory (HCDI).
Time frame: Baseline (pre-intervention); 6 weeks post-intervention
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
Parenting Stress Index Short Form (PSI-SR).
Time frame: Baseline (pre-intervention); 6 weeks post-intervention
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.
6 secondary outcomes
Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2; Lord et al., 2012).
Time frame: Baseline (pre-intervention); 6 weeks post-intervention
The Mullen Scales of Early Learning (MSEL; Mullen, 1995).
Time frame: Baseline (pre-intervention); 6 weeks post-intervention
Adaptive Behavior Assessment System-Second Edition Parent Form, Ages 0-5 (ABAS-II; Harrison & Oakland, 2000).
Time frame: Baseline (pre-intervention); 6 weeks post-intervention
Aberrant Behavior Checklist (ABC; Aman et al., 1985; Kaat et al., 2014).
Time frame: Baseline (pre-intervention); 6 weeks post-intervention
Communication and Symbolic Behavior Scales Developmental Profile (CSBS-DP) Infant-Toddler Checklist
Time frame: Baseline (pre-intervention); 6 weeks post-intervention
Social ABCs Satisfaction Questionnaire (Brian et al., 2016).
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Group Social ABCs Protocol on NIH websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judah Koller, PhD principal investigator
Hebrew University of Jerusalem
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The social ABCs in people with Autism and Autism Spectrum Disorder (ASD), run by Hebrew University of Jerusalem at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability of the Social ABCs Protocol (time frame: immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.