Autism Spectrum DisorderNCT05713162
Evaluation of the Effect of a Social Skills Program for Children and Adolescents With ASD
A study testing Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004). in people with Autism Spectrum Disorder, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2017to 30 Apr 2019
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age range between 8 and 17 years old
- confirmed diagnosis of autism spectrum disorder according to Diagnostic and Statistical Manual, fifth version (APA, 2013)
- meeting cut-off at the Autism Diagnostic Observation Schedule-2 (ADOS-2, Lord et al., 2000)
- normal range of Verbal Comprehension.
Who cannot join
- severe behavioral problems
- several mental psychopathologies such as schizophrenia
- intellectual functioning below 80.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Sant Joan de Déu Barcelona Children's Hospital, Sant Joan de Déu Research Foundation (Research Institute)
Barcelona
About this study
Official title: Evaluation of the Effectiveness of a Social Skills Group Intervention Program for Children and Adolescents With Autism Spectrum Disorder
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.
Read the 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 (e.g., anxiety, depression, etc.) and externalizing behaviors (e.g., aggression, hyperactivity, etc.) are evaluated. The present study focused specifically on: Anxious/Depressed, Social Problems and Thought Problems.
The Spence Children's 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 (i.e., 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%) Cohen's 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 program's last session), and multidimensional (several dimensions of the observation instrument were considered suitable) (Nomothetic/follow-up/Multidimensional). 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 v23.0) 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 0.05, while marginally significant was understood to be below 0.10 and above 0.05, 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004).
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004).Behavioural
The social skills intervention program was based on a consented adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004). In order to be feasible in a hospital-based service, we adapted the program to 10 sessions. Session structure 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. We also adapted the content of the sessions, including activities proposed by Solomon (2004) but also from other experts in social cognition, such as García-Winner (2000). Each group was comprised by 7-10 participants. Children groups were conducted by a clinical psychologist, a mental health nurse and the support of two master degree students. Adolescent groups were conducted by a psychologist, a psychiatrist and the support of two master degree students.
| Study group | Role | What they receive |
|---|---|---|
| Children experimental group | Experimental | Children who receive 10 sessions of the social skills training program Receives: Behavioral: Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004). |
| Adolescent experimental group | Experimental | Adolescents who receive 10 sessions of the social skills training program Receives: Behavioral: Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004). |
| Children control group | No intervention | Children in waiting list (do not receive 10 sessions of the social skills training program) |
| Adolescent control group | No intervention | Adolescents in waiting list (do not receive 10 sessions of the social skills training program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline number of social behaviors as measured by an observational instrument at 10 weeks later (after intervention)
In order to quantitatively code social behaviors, we applied an observational instrument. First of all, we reorganized and developed an observational instrument inspired by a previous observational instrument and by the approach of social difficulties of the authors of Autism Diagnosis Observational Schedule-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.
Measured: Change from Baseline number of social conducts at 10 weeks later (after intervention)
Secondary outcomes (2)
Change from baseline results in Child Behavior Checklist (CBCL/6-18): (Achenbach, T. 1992)
The CBCL 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 (e.g., anxiety, depression, etc.) and externalizing behaviors (e.g., aggression, hyperactivity, etc.) are evaluated. Our study focus specifically on: Anxious/Depressed, Social Problems and Thought Problems.
Measured: Change from Baseline comorbid symptoms to 10 weeks later (immediately after the intervention)
Change from baseline results in The Spence Children's Anxiety Scale (SCAS): (Spence, 1997):
The SCAS 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.
Measured: Change from Baseline anxiety symptoms to 10 weeks later (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 posted6 Feb 2023
- Study start30 Jan 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria A Mairena, PhD, Principal investigator, Sant Joan de Déu Barcelona Children's Hospital, Sant Joan de Déu Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713162
- Sponsor's protocol ID
- PIC-04-17
- Status last verified
- Mar 2022
- First submitted
- 30 Aug 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alcover C, Mairena MA, Mezzatesta M, Elias N, Diez-Juan M, Balana G, Gonzalez-Rodriguez M, Rodriguez-Medina J, Anguera MT, Arias-Pujol E. Mixed Methods Approach to Describe Social Interaction During a Group Intervention for Adolescents With Autism Spectrum Disorders. Front Psychol. 2019 Jun 4;10:1158. doi: 10.3389/fpsyg.2019.01158. eCollection 2019.
PubMed 31231268Alcover C, Mairena MA, Rodriguez-Medina J, Mezzatesta M, Balana G, Elias N, Elias M, Arias-Pujol E. Measuring Changes in Social Skills Throughout an Intervention Program for Children with ASD, Contributions from Polar Coordinate Analysis. J Autism Dev Disord. 2023 Jun;53(6):2246-2260. doi: 10.1007/s10803-022-05496-0. Epub 2022 Mar 12.
PubMed 35279764
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Social Skills Group Intervention Program for Children and Adolescents With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05713162
- Acronym / sponsor ID
- PIC-04-17
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 6 Feb 2023 (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.
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.
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 (e.g., anxiety, depression, etc.) and externalizing behaviors (e.g., aggression, hyperactivity, etc.) are evaluated. The present study focused specifically on: Anxious/Depressed, Social Problems and Thought Problems.
The Spence Children's 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 (i.e., 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%) Cohen's 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 program's last session), and multidimensional (several dimensions of the observation instrument were considered suitable) (Nomothetic/follow-up/Multidimensional). 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 v23.0) 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 0.05, while marginally significant was understood to be below 0.10 and above 0.05, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children experimental group | Experimental | Behavioral: Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004).Children who receive 10 sessions of the social skills training program |
| Adolescent experimental group | Experimental | Behavioral: Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004).Adolescents who receive 10 sessions of the social skills training program |
| Children control group | No intervention | –Children in waiting list (do not receive 10 sessions of the social skills training program) |
| Adolescent control group | No intervention | –Adolescents in waiting list (do not receive 10 sessions of the social skills training program) |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age range between 8 and 17 years old
- confirmed diagnosis of autism spectrum disorder according to Diagnostic and Statistical Manual, fifth version (APA, 2013)
- meeting cut-off at the Autism Diagnostic Observation Schedule-2 (ADOS-2, Lord et al., 2000)
- normal range of Verbal Comprehension.
Key exclusion criteria (3 listed)
- severe behavioral problems
- several mental psychopathologies such as schizophrenia
- intellectual functioning below 80.
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 |
|---|---|---|
| Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004).The social skills intervention program was based on a consented adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004). In order to be feasible in a hospital-based service, we adapted the program to 10 sessions. Session structure 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. We also adapted the content of the sessions, including activities proposed by Solomon (2004) but also from other experts in social cognition, such as García-Winner (2000). Each group was comprised by 7-10 participants. Children groups were conducted by a clinical psychologist, a mental health nurse and the support of two master degree students. Adolescent groups were conducted by a psychologist, a psychiatrist and the support of two master degree students. | Behavioural | Adolescent experimental group, Children experimental group |
Primary outcome
Change from baseline number of social behaviors as measured by an observational instrument at 10 weeks later (after intervention)
Time frame: Change from Baseline number of social conducts at 10 weeks later (after intervention)
In order to quantitatively code social behaviors, we applied an observational instrument. First of all, we reorganized and developed an observational instrument inspired by a previous observational instrument and by the approach of social difficulties of the authors of Autism Diagnosis Observational Schedule-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.
2 secondary outcomes
Change from baseline results in Child Behavior Checklist (CBCL/6-18): (Achenbach, T. 1992)
Time frame: Change from Baseline comorbid symptoms to 10 weeks later (immediately after the intervention)
Change from baseline results in The Spence Children's Anxiety Scale (SCAS): (Spence, 1997):
Time frame: Change from Baseline anxiety symptoms to 10 weeks later (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 6 Feb 2023.
- Background: PubMed 31231268Alcover C, Mairena MA, Mezzatesta M, Elias N, Diez-Juan M, Balana G, Gonzalez-Rodriguez M, Rodriguez-Medina J, Anguera MT, Arias-Pujol E. Mixed Methods Approach to Describe Social Interaction During a Group Intervention for Adolescents With Autism Spectrum Disorders. Front Psychol. 2019 Jun 4;10:1158. doi: 10.3389/fpsyg.2019.01158. eCollection 2019.
- Background: PubMed 35279764Alcover C, Mairena MA, Rodriguez-Medina J, Mezzatesta M, Balana G, Elias N, Elias M, Arias-Pujol E. Measuring Changes in Social Skills Throughout an Intervention Program for Children with ASD, Contributions from Polar Coordinate Analysis. J Autism Dev Disord. 2023 Jun;53(6):2246-2260. doi: 10.1007/s10803-022-05496-0. Epub 2022 Mar 12.
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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.
Maria A Mairena, PhD principal investigator
Sant Joan de Déu Barcelona Children's Hospital, Sant Joan de Déu Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004). in people with Autism Spectrum Disorder, run by Fundació Sant Joan de Déu at 1 site in Spain.
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 4 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 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Change from baseline number of social behaviors as measured by an observational instrument at 10 weeks later (after intervention) (time frame: Change from Baseline number of social conducts at 10 weeks later (after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713162, which also lists 2 linked publications.
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 6 Feb 2023.