ISRCTN ISRCTN16636069
DOI https://doi.org/10.1186/ISRCTN16636069
Secondary identifying numbers 2016-05-12-001
Submission date
02/02/2017
Registration date
03/02/2017
Last edited
15/03/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims:
Autism Spectrum Disorders (ASD) are a common group of disorders that affect the way that a person communicates and relates to others. It is a spectrum condition and so the severity of the condition is spread across a wide range, from almost unnoticeable to completely debilitating. In general the symptoms involve problems with social communication (speech and body language), social interaction (recognising and expressing emotions) and social imagination (being able to understand and predict other people’s behaviour). ASD usually occurs in early childhood and can affect the way affected children develop. Social skills training programs could be a good way of helping children with ASD to better interact with people around them and avoid social isolation. This study is looking at a newly developed social skills program that uses cooperative games that involve real-life situations rather than theoretical teaching. The aim of this study is to find out whether this program can help improve the social skills and empathy (ability to understand the feelings of others) of children with ASD.

Who can participate?
Children aged 9-11 years old who have ASD without learning difficulties who are treated in a child psychiatry day hospital.

What does the study involve?
All children take part in the social skills training program for 22 weeks. This involves using playful medium, including board games, strategy games and individual games that we transformed into cooperative games by modifying the rules. Sessions take place every week and last for around 30 minutes. At the start of the study and 22 weeks later, parents and caregivers fill in questionnaires about the children to see if their social skills and empathy have improved.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved for participants in this study.

Where is the study run from?
Sainte Marguerite Hospital (France)

When is the study starting and how long is it expected to run for?
August 2015 to May 2016

Who is funding the study?
Assistance Publique Hôpitaux de Marseille (France)

Who is the main contact?
Dr Jokthan Guivarch

Contact information

Dr Jokthan Guivarch
Scientific

Child Psychiatry
Hospital Sainte Marguerite
270 boulevard de Sainte Marguerite
Marseille
13009
France

ORCiD logoORCID ID 0000-0003-3075-6098

Study information

Study designNon-randomised interventional study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Scientific titleImpact of an implicit social skills training group in children with autism spectrum disorder without intellectual disability: A before-and-after study.
Study objectives1. The social skills of children with autism spectrum disorders are improved by participating in implicit social skills groups
2. The cognitive dimension of empathy of children with autism spectrum disorders are improved by participating in implicit social skills groups
Ethics approval(s)University of Aix Marseille Ethics Committee, 08/12/2016, ref: 2016-05-12-001
Health condition(s) or problem(s) studiedAutism spectrum disorder
InterventionAll participants take part in the social skills training program for 22 weeks. The goal is to work on different social and emotional situations to develop mentalization, cooperation, and assertiveness abilities in children. To maintain motivation, sessions are adapted from week to week based on the needs of the children, their difficulties, and their expectations. Fun, including strategy games, board games, and individual games that have been transformed into cooperative games by modifying the rules are used to encourage effective communication and cooperation between the children to reach the end of the games.

Each of the weekly 30-minute sessions are structured in the same way, with routines for better child adherence. The children’s social skills are assessed before and after 22 weeks of groups. Given the complexity of the social skills, their multidimensional character, and the lack of a baseline tool in the French language, we used a judgment criterion combining the Social-Emotional Profile (SEP), the CARS, and the Empathy Quotient (EQ). The questionnaires for determining the empathy quotient are filled out by the parents, and the SEP and CARS were completed by the caregivers.
Intervention typeBehavioural
Primary outcome measureChildren’s social skills are assessed using a judgment criterion combining the PSA (Social-Emotional Profile), the CARS and the Empathy Quotient at baseline and 22 weeks. The questionnaires for determining the empathy quotient are filled out by the parents, and the SEP and CARS are completed by the caregivers.
Secondary outcome measuresCognitive empathy is measured by separating the items in the French-language questionnaire (of Empathy Quotient) depending to wether they referred more to cognitive empathy or emotional empathy, at baseline and 22 weeks.
Overall study start date05/08/2015
Completion date20/05/2016

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit9 Years
Upper age limit11 Years
SexBoth
Target number of participants8
Total final enrolment6
Key inclusion criteria1. Aged 9 to 11 years old
2. Autism spectrum disorder (The ASD diagnostic is established clinically and confirmed through standard observation of the child ADOS)
3. No intellectual disability (IQ > 70)
4. Treated at least half a day each week in a child psychiatry day in Marseille
5. Participation in an implicit social skills group
Key exclusion criteriaInterruption of participation in social skills group
Date of first enrolment05/10/2015
Date of final enrolment09/10/2015

Locations

Countries of recruitment

  • France

Study participating centre

Sainte Marguerite Hospital
Department of Child Psychiatry
270 boulevard de Sainte Marguerite
Marseille
13009
France

Sponsor information

Assistance Publique Hôpitaux de Marseille
Hospital/treatment centre

270 boulevard de Sainte Marguerite
Marseille
13009
France

ROR logo "ROR" https://ror.org/002cp4060

Funders

Funder type

Hospital/treatment centre

Assistance Publique Hôpitaux de Marseille

No information available

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal in 2017/2018.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Jokthan Guivarch (Jokthan.GUIVARCH@ap-hm.fr)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 17/07/2017 15/03/2023 Yes No

Editorial Notes

15/03/2023: Publication reference and total final enrolment added.