Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05713162
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2022-08-30
Brief Title:
Evaluation of the Effect of a Social Skills Program for Children and Adolescents With ASD
Sponsor:
Fundació Sant Joan de Déu
Organization:
Fundació Sant Joan de Déu
Study Overview
Official Title:
Evaluation of the Effectiveness of a Social Skills Group Intervention Program for Children and Adolescents With Autism Spectrum Disorder
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Research evaluating effectiveness of social skills intervention programs for children and adolescents with Autism Spectrum Disorder is still limited
The main objective of this study was to develop an adaptation of the Social Adjustment Enhancement Intervention program form the University of California for a group of children and adolescents with autism Our secondary goal was to evaluate the effect of our program through specific indicators We hypothesized a decrease in comorbid symptomatology as measured by questionnaires We also expected an increase in social behaviors measured through observational methodology
The main objective of this study was to develop an adaptation of the Social Adjustment Enhancement Intervention program form the University of California for a group of children and adolescents with autism Our secondary goal was to evaluate the effect of our program through specific indicators We hypothesized a decrease in comorbid symptomatology as measured by questionnaires We also expected an increase in social behaviors measured through observational methodology
Detailed Description:
Participants were recruited by psychologists and psychiatrists from a Multidisciplinary Unit for Autism Spectrum Disorder in accordance the 2000 Helsinki declaration
A total sample of 94 participants was divided in two age-groups children 8 to 12 years old and adolescents 13-17 years old These groups participated in the study over a three-year period 2017 2018 and 2019 Each year the investigators recruited approximately 30 participants children and adolescents Subjects were paired according to age gender and intelligence quotient then each pair was randomized between the two groups experimental group and waiting list control group using R software with a fixed random seed
The experimental group of each year received treatment from January to April The waiting list control group received the treatment from April to July after participating in the trial For both groups pre-treatment evaluation was performed in January and post-treatment evaluation was done in April The treatment groups were conducted by one psychologist two co-therapists psychiatrists or mental health nurses and with the assistance of two graduate students in psychology Fifteen participants were excluded due to missing data
Materials and design Diagnostic instruments The Autism Diagnostic Observation Schedule-2 was administered to all participants To be included in the study participants had to score above the cut-off point Intellectual abilities and verbal comprehension were measured with the Wechsler Intelligence Scale for Children and Adolescents
Outcome measurement instruments
Pre- and post-questionnaires for parents were administered to assess comorbid symptomatology
Child Behavior Checklist 6-18 This instrument is a questionnaire filled out by parents to assess behaviors and emotional problems in subjects aged 1 year 6 months to 5-years old and 6 to 18 years old Both internalizing behaviors eg anxiety depression etc and externalizing behaviors eg aggression hyperactivity etc are evaluated The present study focused specifically on AnxiousDepressed Social Problems and Thought Problems
The Spence Childrens Anxiety Scale This instrument is a self-report that measures anxiety disorders in childhood and adolescence It consists of 44 items that assess separation anxiety obsessive-compulsive disorder panic social phobia generalized anxiety etc It is evaluated from a Likert scale with a maximum score of 114 average 57 and minimum 0
Experimental Coding of Social Behavior To assess social behaviors the investigators coded 14 minutes of free playtime from session 2 and session 10 last session Free playtime consisted of participants playing with each other in a non-structured format using different games that were offered or remaining alone if they wanted to Therapists and co-therapists did not interact during free playtime Coded videos were recorded with two different cameras located at two different fixed angles Observational data corresponded to participants that attended the specific sessions ie sessions 2 and 10 needed for these analyses and they allowed coders based on audiovisual characteristics sufficient coding time and angles to code the target behaviors In order to obtain baseline observational data from the control group this group was scheduled for two free playtime sessions coinciding with sessions 1 and 2 from the experimental group the second session was videocoded To obtain follow-up data from the control group another free playtime session was scheduled three months later
Participants were informed about the recording the research purpose of the videos and the location of the cameras
In order to quantitatively code social behaviors an observational instrument was developed and administered This instrument was inspired by a previous observational instrument and by the approach of social difficulties of the authors of the Autism Diagnostic Observation-2 This instrument allows the observer to quantify the number of occurrences of target behaviors according to pre-established categories The scale includes six defined dimensions and category systems that meet the requirements of exhaustively and mutual exclusivity
A systematic observation was performed to obtain a code matrix Two coders analyzed and coded the entire set of videos In order to assure reliability between coders 20 of videos were coded for these propose and coders were blind to the randomized session number sessions 2 and 10 that they were assigned to code Two blinded coders performed a training phase until reaching a moderate-to-high 76-89 Cohens Kappa agreement rate prior to coding the videos that were then analyzed for this study
The observational design was nomothetic several participants were observed included follow-up an initial session and the programs last session and multidimensional several dimensions of the observation instrument were considered suitable Nomotheticfollow-upMultidimensional As the therapeutic process extended to several sessions the groups were considered as a plurality of units We worked with two levels of response verbal and non-verbal
Procedures Parents were invited to attend an informative session in which the study was presented Afterwards signed consent and informed assent was obtained from each child Sessions took place in a dedicated group-intervention room and had a length of 90 minutes per session
The social skills intervention program was based on a consented adaptation of the Social Adjustment Enhancement Intervention of the University of California The original design contains more than 20 sessions but in order to be feasible in a Hospital-based service we adapted the program to 10 sessions and eliminated the parent component According to previous community research evidenced-based intensive intervention programs are challenging to implement and they have long waiting lists Therefore there is a tendency to limit the length of group intervention programs to a fewer number of sessions in order to provide higher access to services For this study the number of sessions was decreased and the program was simplified in order to make it feasible to our hospital setting Session structure was consistent and included initial greeting free play time didactic joke telling and closing activities Topics of didactic sessions were related to social competence such as empathy talking about feelings and solving social problems Each session had the purpose of practicing different social competence skills that are typically affected in a young population with Autism Spectrum Disorder
Data analysis The Statistical Package for the Social Sciences SPSS v230 was used for statistical analyses Descriptive analyses were conducted to characterize the sample To test hypotheses 2x2 ANOVA analyses were conducted comparing differences between groups experimental vs control and time baseline vs follow up The amount of social behaviors and psychological symptoms were compared
All statistical tests were performed with a bilateral contrast and the level of significance was set at 005 while marginally significant was understood to be below 010 and above 005 so as to better understand our results and potential discussion Based on the previous literature the analyses described above were replicated stratifying by verbal IQ and age
A total sample of 94 participants was divided in two age-groups children 8 to 12 years old and adolescents 13-17 years old These groups participated in the study over a three-year period 2017 2018 and 2019 Each year the investigators recruited approximately 30 participants children and adolescents Subjects were paired according to age gender and intelligence quotient then each pair was randomized between the two groups experimental group and waiting list control group using R software with a fixed random seed
The experimental group of each year received treatment from January to April The waiting list control group received the treatment from April to July after participating in the trial For both groups pre-treatment evaluation was performed in January and post-treatment evaluation was done in April The treatment groups were conducted by one psychologist two co-therapists psychiatrists or mental health nurses and with the assistance of two graduate students in psychology Fifteen participants were excluded due to missing data
Materials and design Diagnostic instruments The Autism Diagnostic Observation Schedule-2 was administered to all participants To be included in the study participants had to score above the cut-off point Intellectual abilities and verbal comprehension were measured with the Wechsler Intelligence Scale for Children and Adolescents
Outcome measurement instruments
Pre- and post-questionnaires for parents were administered to assess comorbid symptomatology
Child Behavior Checklist 6-18 This instrument is a questionnaire filled out by parents to assess behaviors and emotional problems in subjects aged 1 year 6 months to 5-years old and 6 to 18 years old Both internalizing behaviors eg anxiety depression etc and externalizing behaviors eg aggression hyperactivity etc are evaluated The present study focused specifically on AnxiousDepressed Social Problems and Thought Problems
The Spence Childrens Anxiety Scale This instrument is a self-report that measures anxiety disorders in childhood and adolescence It consists of 44 items that assess separation anxiety obsessive-compulsive disorder panic social phobia generalized anxiety etc It is evaluated from a Likert scale with a maximum score of 114 average 57 and minimum 0
Experimental Coding of Social Behavior To assess social behaviors the investigators coded 14 minutes of free playtime from session 2 and session 10 last session Free playtime consisted of participants playing with each other in a non-structured format using different games that were offered or remaining alone if they wanted to Therapists and co-therapists did not interact during free playtime Coded videos were recorded with two different cameras located at two different fixed angles Observational data corresponded to participants that attended the specific sessions ie sessions 2 and 10 needed for these analyses and they allowed coders based on audiovisual characteristics sufficient coding time and angles to code the target behaviors In order to obtain baseline observational data from the control group this group was scheduled for two free playtime sessions coinciding with sessions 1 and 2 from the experimental group the second session was videocoded To obtain follow-up data from the control group another free playtime session was scheduled three months later
Participants were informed about the recording the research purpose of the videos and the location of the cameras
In order to quantitatively code social behaviors an observational instrument was developed and administered This instrument was inspired by a previous observational instrument and by the approach of social difficulties of the authors of the Autism Diagnostic Observation-2 This instrument allows the observer to quantify the number of occurrences of target behaviors according to pre-established categories The scale includes six defined dimensions and category systems that meet the requirements of exhaustively and mutual exclusivity
A systematic observation was performed to obtain a code matrix Two coders analyzed and coded the entire set of videos In order to assure reliability between coders 20 of videos were coded for these propose and coders were blind to the randomized session number sessions 2 and 10 that they were assigned to code Two blinded coders performed a training phase until reaching a moderate-to-high 76-89 Cohens Kappa agreement rate prior to coding the videos that were then analyzed for this study
The observational design was nomothetic several participants were observed included follow-up an initial session and the programs last session and multidimensional several dimensions of the observation instrument were considered suitable Nomotheticfollow-upMultidimensional As the therapeutic process extended to several sessions the groups were considered as a plurality of units We worked with two levels of response verbal and non-verbal
Procedures Parents were invited to attend an informative session in which the study was presented Afterwards signed consent and informed assent was obtained from each child Sessions took place in a dedicated group-intervention room and had a length of 90 minutes per session
The social skills intervention program was based on a consented adaptation of the Social Adjustment Enhancement Intervention of the University of California The original design contains more than 20 sessions but in order to be feasible in a Hospital-based service we adapted the program to 10 sessions and eliminated the parent component According to previous community research evidenced-based intensive intervention programs are challenging to implement and they have long waiting lists Therefore there is a tendency to limit the length of group intervention programs to a fewer number of sessions in order to provide higher access to services For this study the number of sessions was decreased and the program was simplified in order to make it feasible to our hospital setting Session structure was consistent and included initial greeting free play time didactic joke telling and closing activities Topics of didactic sessions were related to social competence such as empathy talking about feelings and solving social problems Each session had the purpose of practicing different social competence skills that are typically affected in a young population with Autism Spectrum Disorder
Data analysis The Statistical Package for the Social Sciences SPSS v230 was used for statistical analyses Descriptive analyses were conducted to characterize the sample To test hypotheses 2x2 ANOVA analyses were conducted comparing differences between groups experimental vs control and time baseline vs follow up The amount of social behaviors and psychological symptoms were compared
All statistical tests were performed with a bilateral contrast and the level of significance was set at 005 while marginally significant was understood to be below 010 and above 005 so as to better understand our results and potential discussion Based on the previous literature the analyses described above were replicated stratifying by verbal IQ and age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None