Pilot Evaluation of the Social ABCs Parent-Mediated Intervention for Autistic Toddlers in Israel
Phase: NA
Conditions: Autism, Autism Spectrum Disorder (ASD)
Sponsor: Hebrew University of Jerusalem

 
 
טופס בקשה לאישור של ועדת אתיקה למחקרים בבני אדם 
כל העוסק במחקר בו מעורבים בני אדם חייב בתעודה שעבר/ה הכשרה אתית 
הטופס כתוב בלשון זכר אולם הוא מתייחס לחוקרות ולחוקרים כאחד 
 
 :תאריך 
2020
/
6
0
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8
1
 
:שם החוקר האחראי 
r. Judah Koller
D
 
 :מספר טלפון0584174873
 
                    
    
:דואר אלקטרוני 
@mail.huji.ac.il
judah.koller
 
 :פקולטה/בית ספר 
ducation
School of E
 
 
1
.
 
 :נושא המחקר 
This study proposes to assess the efficacy of an evidence-based, parent-mediated 
intervention (Social ABCs) for children recently diagnosed with autism spectrum disorder 
(ASD) and their parents.  
2
.
 
 :סיכום קצר של המחקר ומטרתו 
The Social ABCs is an evidence-based, parent-mediated intervention for toddlers (12-36 
months) with autism or related social-communication challenges. The study has two 
phases. The first involves recruiting providing the intervention directly to the children. 
The second involves coaching parents in these techniques, so that they can work with 
their children more intensively long-term. All sessions will be videotaped for the 
purposes of research. The therapists (Dr. Koller and two graduate students in the School 
of Education: Tamar Matz and Tamar David) are being trained in the intervention by 
Canadian collaborators. Therefore, these trainers will virtually (Zoom) join a portion of 
the meetings with families in order to supervise and train the interventionists. 
The Social ABCs focuses on two primary skills: language development and shared social 
affect. The research team will use the parent manual to help guide the children, and 
then the parents, to begin implementing specific skills/techniques in their daily routines. 
The goal of the research project is to assess the efficacy of the Social ABCs. Upon 
completion of the campus-based stage of training, we will evaluate the feasibility and 
efficacy of delivering the Social ABCs intervention in Israel using formal outcome 
measures, such as parent implementation fidelity, child responsiveness, etc. We will also 

 
examine a number of novel family and parent-specific characteristics as outcome 
measures and predictors. The families will meet with a member of the research team, 
either individually or in groups, over the course of six weeks. In some cases the meetings 
will be didactic, wherein the researcher will be teaching the parent the background 
needed to implement the intervention, and in other cases the meetings will be 
interactive, wherein the researcher will be interacting with the child or will be guiding 
the parent in their interaction with the child.  
 
3
.
 
:מקור מימון המחקר פנים אוניברסיטאי, חיצוני, מימון עצמי  
This research is funded by the Canadian Friends of the Hebrew University. 
 
4
.
 
 :תיאור משתתפי המחקר והאוכלוסייה ממנה ייבחרו כולל מספר המשתתפים 
Study population: 
50 children aged 12-36 months who have recently been diagnosed with ASD, and their 
primary caregiver(s). The children will be recruited from a variety of avenues, including 
those who go through the diagnostic process at Clalit and will be referred to our study.  
 
5
.
 דרך בחירת המשתתפים, כולל קריטריוני הכללה : 
 
The children must be between 12-36 months with an officially recognized diagnosis of 
ASD. 
 
6
.
 
 נוהל איסוף הנתונים (במידה של שימוש בשאלונים יש לצרפם לבקשה) ומשך המחקר
 :המתוכנן 
 
The parents will complete questionnaires. In addition, certain standardized measures 
will also be given to the children directly, including a social-behavioral assessment 
(Autism Diagnostic Observation Scale-2), a cognitive assessment (Mullen), a language 
assessment (Preschool Language Scale-4), an adaptive behavior assessment (Adaptive 
Behavior Assessment System-2) and an autism severity scale assessment (SRS-2/ASRS). 
Each group/individual will meet 15 times, for 1-1.5 hours each meeting, over the course 
of the 6 weeks. The meetings will gradually decrease in frequency, starting with three 

 
times per week for the first three weeks of the intervention. In the initial phase, 
clinicians will work directly with children for the purposes of training. These sessions will 
be recorded and supervised both through video and live. The project overall is planned 
to run for two years. 
 
7
.
 
 ,תיאור הסיכונים הצפויים לנבדק (כולל חוסר נוחות אפשרית בתחום הגופני, הפסיכולוגי
 ,החברתי 
 הכלכלי או אחר), שעלולים להיגרם כתוצאה מהמעורבות במחקר. התייחס בבקשה
 הן להסתברות 
:הסיכון והן לחומרתו 
 
 
No risk is expected. Parents might experience mild discomfort while discussing their child's 
developmental delays in a group format, but it is expected that they will also experience a 
degree of comfort and support from the other group members 
 
8
.
 
:האמצעים שיינקטו למזער את הסיכונים או אי הנוחות האפשריים 
 
9
.
 
No parent will be forced to talk in groups and every participant will know that they 
are able to withdraw from the study at any point with no repercussions.
 
 
10
. ית אור התועלת האפשרית מעריכת המחקר עבור המשתתפים עצמם, אוכלוסיית
 :המשתתפים והחברה 
 
As previously mentioned, the participants will be receiving an intervention, which will help 
them address some of their child's social-communication skills. This kind of intervention 
would otherwise be very expensive for the participants. Should the intervention prove 
effective, it could be used for many young children who have just been diagnosed. These 
families are often not immediately placed in a special education kindergarten or other 
intervention program, and as such this could serve in the interim to help them move forward 
with help for their children. More generally, knowledge about how the Social ABCs can 
impact the social and linguistic development of children with autism will contribute to the 
growing body of research about how to best address the needs of this population.  
 
10
. 
 מתן הסבר כיצד עולה התועלת האפשרית מהמחקר על הסיכונים האפשריים ממנו, וכיצד ניתן 
 :להצדיק סיכונים אלה 

 
As mentioned above, the only potential risk is the mild discomfort the parents may feel 
about sharing their child's difficulties in a group setting. However, the potential outcomes 
the intervention may provide for these families, and specifically these children, far outweigh 
the risks. 
11
 .
 אילו אמצעים יינקטו להבטחת חשאיות המשתתפים במחקר ולהגנת המידע והנתונים שייאספו
על 
:המשתתפים 
 
All the information collected on the participants will be anonymized before the data is 
entered into an online system. Each participant will receive a random number to identify 
them in the system. As the intervention meetings will be filmed, the videos will be uploaded 
into a secure system and will not be shared outside of the research study team unless the 
participant signs an informed consent. All these details will be included in the informed 
consent form the participants will sign before joining the study.   
12
. 
 :כיצד תישמר הגישה אל הנתונים 
 
Only the researchers in the study will have access to the data and the videos. The data will 
be password-protected. 
13
. 
 :כיצד תישמר זהות המשתתפים 
 
The names of the participants will be kept separately from the rest of the study materials.  
14
. 
 :האם יהיה תשלום לנבדקים ואם כן, באיזה סכום, כיצד הוא יינתן ומתי 
 
No payment will be offered. 
 
 
15
. 
 ההסכמה להשתתף במחקר - 
 :מי אחראי על קבלת הסכמה מדעת מהנבדק 
 
The families who agree to participate in the study will be given an informed consent form in 
the baseline meeting, which they will be required to sign before continuing with the study. 
The consent form will be kept in the study files and will be collected by the researcher 
leading the meeting.  
16
. 
:באיזה אופן תתקבל ההסכמה, איפה ומתי 
 
The informed consent form will be given to the participant at the beginning of the baseline 
meeting. They will read it, the researcher will answer any questions regarding the form, and 
then the participant will sign before continuing with the process. Should an in-person 
meeting not be possible, the informed consent will be sent to the participants via email, the 

 
researchers will be available to answer questions regarding the content, and the participants 
will have to electronically sign and return the form before continuing with the intervention 
process.  
 יש לצרף טופס ההסכמה שייעשה בו שימוש במחקר–
 
 ראו נספח בנושא, בהמשך טופס זה 
 
:חתימת החוקר 
 
 
 
 
 :החלטת הועדה________________________________________________________
 
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