Condition category
Mental and Behavioural Disorders
Date applied
02/02/2017
Date assigned
03/02/2017
Last edited
03/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jokthan Guivarch

ORCID ID

http://orcid.org/0000-0003-3075-6098

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016-05-12-001

Study information

Scientific title

Impact of an implicit social skills training group in children with autism spectrum disorder without intellectual disability: A before-and-after study.

Acronym

Study hypothesis

1. 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

University of Aix Marseille Ethics Committee, 08/12/2016, ref: 2016-05-12-001

Study design

Non-randomised interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Autism spectrum disorder

Intervention

All 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 type

Behavioural

Phase

Drug names

Primary outcome measures

Children’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 measures

Cognitive 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 trial start date

05/08/2015

Overall trial end date

20/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

8

Participant exclusion criteria

Interruption of participation in social skills group

Recruitment start date

05/10/2015

Recruitment end date

09/10/2015

Locations

Countries of recruitment

France

Trial participating centre

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

Sponsor information

Organisation

Assistance Publique Hôpitaux de Marseille

Sponsor details

270 boulevard de Sainte Marguerite
Marseille
13009
France

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Assistance Publique Hôpitaux de Marseille

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in 2017/2018.

IPD Sharing plan:
The 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)

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes