Autism Spectrum DisorderNCT03177525
Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder
A study testing Social SUCCESS and Wait List in people with Autism Spectrum Disorder, run by Stanford University at 1 site in United States.
Trial summary
Children with autism spectrum disorder (ASD) exhibit characteristic deficits in social initiation and there are no empirically validated treatments specifically for this core deficit. While parent training is known to be a critical intervention component, few social skills programs involve parents. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Social SUCCESS and Wait List
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2017to 23 Nov 2021
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child aged 4.0 to 6.11 years
- child diagnosed with ASD (Autism Diagnostic Observation Schedule; ADOS-2)
- child without intellectual disability (Stanford Binet Intelligence Scales; SB-5)
- parent able to consistently participate in parent training sessions and complete study measures
Who cannot join
- child with other severe psychiatric disorder
- child with known genetic condition (e.g., Fragile X, Retts)
- child with unstable medical condition (e.g., active seizures)
Trial locations and contacts
1 site in 1 country.
About this study
Children with autism spectrum disorder (ASD) exhibit characteristic deficits in social initiation and there are no empirically validated treatments specifically for this core deficit. While parent training is known to be a critical intervention component, few social skills programs involve parents. This study will capitalize on an existing social skills group already established at the community agency Abilities United, with the goal of enhancing the program's effectiveness by adding a parent component. Specifically, the proposed study will investigate whether a novel parent mediated social skills program (Social SUCCESS), which provides parent training in conjunction with a social skills group intervention, will result in more frequent initiations during play with typically developing peers. Participants will include 50 children with ASD age 4:0 to 6:11 years. Children will be randomly assigned to either Social SUCCESS (N=25) or waiting list (N=25). Treatment will be provided for 8 weeks during a weekly 120-minute social skills group at Abilities United. The study will evaluate the effects of Social SUCCESS on areas of core social deficit including frequency of peer initiations using parent ratings, observational measures, standardized questionnaires, and a social eye tracking task. Outcomes will be compared to a waiting list control group. Findings will be disseminated through presentations and publications to aid clinicians in providing more effective social skills treatment for children with ASD and to enhance the scientific knowledge-base related to evidence-based social skills treatments. This research designed with the goal of stimulating additional scientific inquiry in the area of treatment for core social deficits in ASD and will provide a strong foundation for larger scale grants to study motivation-based interventions to improve social functioning.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Social SUCCESS, Wait List
- Keywords
- parent training, social skills
- Medical subject headings
- Autism Spectrum Disorder, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social SUCCESSBehavioural
Social SUCCESS will run for 12 weeks, with up to 5 children with ASD per group. Parents will attend didactic group sessions focused on motivating children with ASD to initiate to peers (90 min weekly) and will attend a portion of the existing 90 min social group to practice applying these strategies with their children and peer volunteers. Parent training will utilize the manual "Improving Socialization in Individuals with Autism".
Wait ListBehavioural
Participants assigned to the Wait List will continue stable community treatments for 12 weeks and will be provided an intervention similar to Social SUCCESS upon completion of all post measures.
| Study group | Role | What they receive |
|---|---|---|
| Social SUCCESS | Experimental | Not described Receives: Behavioral: Social SUCCESS |
| Wait List | Other | Not described Receives: Behavioral: Wait List |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale Rating from Baseline to Week 12
Parent rating on a Visual Analog Scale (VAS) of the child's frequency of initiation will be compared between Baseline and Week 12 to evaluate change
Measured: Baseline, Week 12
Secondary outcomes (4)
Change in frequency of child initiations
Based on behavioral coding of peer play videos by a blind rater using established operational definitions, change between baseline and week 12 in frequency of child initiations will be compared between groups
Measured: Baseline, Week 12
Change in parent fidelity of implementation
Changes in prompting and reinforcement of social initiations between baseline and week 12 scored from video of parent-child interaction by trained raters will be compared between groups
Measured: Baseline, Week 12
Social Responsiveness Scale, Second Edition
Social Responsiveness Scale, Second Edition, Parent Report Form
Measured: Baseline, Week 12, 3-month Follow-up
Social Skills Improvement System
Social Skills Improvement System Parent Report Form
Measured: Baseline, Week 12, 3-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start9 Aug 2017
- Primary completion12 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Gengoux, Stanford University
- Investigators
- Grace W Gengoux, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177525
- Sponsor's protocol ID
- 41867
- Status last verified
- Dec 2021
- First submitted
- 1 Jun 2017
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03177525
- Acronym / sponsor ID
- 41867
- Conditions
- Autism Spectrum Disorder
- Keywords
- parent training, social skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 6 Jun 2017 (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.
Children with autism spectrum disorder (ASD) exhibit characteristic deficits in social initiation and there are no empirically validated treatments specifically for this core deficit. While parent training is known to be a critical intervention component, few social skills programs involve parents. This study will capitalize on an existing social skills group already established at the community agency Abilities United, with the goal of enhancing the program's effectiveness by adding a parent component. Specifically, the proposed study will investigate whether a novel parent mediated social skills program (Social SUCCESS), which provides parent training in conjunction with a social skills group intervention, will result in more frequent initiations during play with typically developing peers. Participants will include 50 children with ASD age 4:0 to 6:11 years. Children will be randomly assigned to either Social SUCCESS (N=25) or waiting list (N=25). Treatment will be provided for 8 weeks during a weekly 120-minute social skills group at Abilities United. The study will evaluate the effects of Social SUCCESS on areas of core social deficit including frequency of peer initiations using parent ratings, observational measures, standardized questionnaires, and a social eye tracking task. Outcomes will be compared to a waiting list control group. Findings will be disseminated through presentations and publications to aid clinicians in providing more effective social skills treatment for children with ASD and to enhance the scientific knowledge-base related to evidence-based social skills treatments. This research designed with the goal of stimulating additional scientific inquiry in the area of treatment for core social deficits in ASD and will provide a strong foundation for larger scale grants to study motivation-based interventions to improve social functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social SUCCESS | Experimental | Behavioral: Social SUCCESS |
| Wait List | Other | Behavioral: Wait List |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child aged 4.0 to 6.11 years
- child diagnosed with ASD (Autism Diagnostic Observation Schedule; ADOS-2)
- child without intellectual disability (Stanford Binet Intelligence Scales; SB-5)
- parent able to consistently participate in parent training sessions and complete study measures
Key exclusion criteria (3 listed)
- child with other severe psychiatric disorder
- child with known genetic condition (e.g., Fragile X, Retts)
- child with unstable medical condition (e.g., active seizures)
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 |
|---|---|---|
| Social SUCCESSSocial SUCCESS will run for 12 weeks, with up to 5 children with ASD per group. Parents will attend didactic group sessions focused on motivating children with ASD to initiate to peers (90 min weekly) and will attend a portion of the existing 90 min social group to practice applying these strategies with their children and peer volunteers. Parent training will utilize the manual "Improving Socialization in Individuals with Autism". | Behavioural | Social SUCCESS |
| Wait ListParticipants assigned to the Wait List will continue stable community treatments for 12 weeks and will be provided an intervention similar to Social SUCCESS upon completion of all post measures. | Behavioural | Wait List |
Primary outcome
Change in Visual Analog Scale Rating from Baseline to Week 12
Time frame: Baseline, Week 12
Parent rating on a Visual Analog Scale (VAS) of the child's frequency of initiation will be compared between Baseline and Week 12 to evaluate change
4 secondary outcomes
Change in frequency of child initiations
Time frame: Baseline, Week 12
Change in parent fidelity of implementation
Time frame: Baseline, Week 12
Social Responsiveness Scale, Second Edition
Time frame: Baseline, Week 12, 3-month Follow-up
Social Skills Improvement System
Time frame: Baseline, Week 12, 3-month Follow-up
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 10 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Grace W Gengoux, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social SUCCESS and Wait List in people with Autism Spectrum Disorder, run by Stanford University at 1 site in United States.
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 10 Dec 2021. 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 United States. 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 in Visual Analog Scale Rating from Baseline to Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2021.