Autism Spectrum DisorderFBREXNCT02897687
Facebook for Social Skills Training in Autism: Project Rex Connect
A study testing Facebook Group and Book Club Group in people with Autism Spectrum Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Twelve participants were randomized to either a Facebook group or a book club group for six weeks. Data was collected on the participants social and behavioral function at both the start and the conclusion of the intervention. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Facebook Group and Book Club Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Aug 2016
- 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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clinical Diagnosis of Autism Spectrum Disorder
- Verbal
Who cannot join
- Non-verbal
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Project Rex Connect: The Utilization of an Online Social Network by an Interprofessional Team to Aid in Skill Acquisition for Patients With Autism Spectrum Disorders
Twelve participants were randomized to either a Facebook group or a book club group for six weeks. Data was collected on the participants social and behavioral function at both the start and the conclusion of the intervention.
Read the detailed description
Research Design
The Project Rex team will randomize up to 12 subjects with Autism Spectrum Disorder who have completed the Project Rex Teen Treatment Group into either:
- (Group F) A closed, invite-only group within Facebook facilitated by an interprofessional team that not only reinforces skills, but also aims to promote bonds and a sense of community and connectedness between participants.
OR
- (Group B) A topical book club group conducted by a single healthcare professional.
Both treatment arms will be 8 weeks in duration. The interprofessional team for the Facebook arm of treatment will consist of one child and adolescent psychiatrist, one psychologist, two social workers and one medical student. The single professional conducting the book club activity will be a medical student. Parents will be required to help facilitate their child's participation in the study treatment. All study subjects will have completed the 8-week social skills introduction to social conversation Project Rex Teen group immediately prior to enrolling in either the Facebook arm (F) or the Book Club arm (B) of the study.
Upon completion of this treatment cycle, the study investigators will conduct an additional treatment cycle by randomizing two additional groups, each comprising up to 12 subjects with Autism Spectrum Disorder who have completed the 8-week Project Rex Teen Treatment Group into either Group F or Group B. The investigators will therefore enroll up to 24 total subjects in the study. The study is being divided into three cycles due to the limitation of recruiting only subjects who have completed the most recent round of the Project Rex teen program. Approval by the Medical University of South Carolina Institutional Review Board will be obtained before beginning this pilot study.
Study Procedure
Patients participating in the Project Rex Teen Group and their parents will be provided with written and verbal information about the opportunity to enroll in this study. This information will be disseminated to patients and parents after the completion of five of the total eight weeks of the Project Rex Teen Group. Patients and their parents will have opportunities to ask questions about the study with co-investigators after the sessions on week 6 and week 7. After the 8-week Project Rex teen group concludes, study co-investigators will be available to obtain informed consent from the parents of the subjects ages 12 to 17 years of age, and to obtain the assent of the respective subjects. The study investigators will also be available to obtain the informed consent of subjects who are age 18 to 20 years at the conclusion of the 8-week Project Rex Teen Group. The parents and subjects will have up to seven days after the conclusion of Week 8 of the Project Rex Teen Group to provide their informed consent and assent, respectively, for enrollment in the study.
Once parents and subjects have provided their informed consent/assent and the subjects are enrolled in the study, each subject will be randomized using REDCap into either Group F (Facebook arm) or Group B (Book Club Arm). Both subject groups and their parents will meet with for an information session about the study and their participation, which will be scheduled to occur within a week of the conclusion of Week 8 of the Project Rex Teen Program. Both treatment groups will meet on the same day and time, but will attend different information sessions located in different rooms within the Institute of Psychiatry.
All subjects who are assigned to the Facebook group and their parents will meet for a 90-minute group information session at Week 1, prior to the start of the Facebook treatment phase. These meetings will be conducted by the study investigators and will include a review of the study procedure, Facebook guidelines and Facebook terms and policy, privacy settings and data collection methods. The study investigators will directly support each subject in setting up their project Rex Facebook account and educating subjects about privacy settings. The study investigators will provide parents with education and training on the use of the Project Rex Facebook account and the maintenance of Project Rex Facebook account privacy settings to ensure that subjects are using the account appropriately and safely. At the conclusion of the Facebook information session, the subjects will be randomly assigned via lottery into two groups (1 \& 2) for the purpose only of posting and responding to the discussion topic of the week.
All subjects and parents who are assigned to the Book Club group will meet for a 90-minute group information session at week 1, prior to the Book Club arm beginning. A study investigator will conduct this meeting and will provide a review of the study procedure, orient participants to the Book Club, review book club rules and expectations, and distribute the books.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Facebook Group, Book Club Group
- Keywords
- Autism Spectrum Disorder, Social Skills, Social Media
- 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.
Facebook GroupBehavioural
A closed, invite-only group within Facebook facilitated by an interprofessional team that not only reinforces skills, but also aims to promote bonds and a sense of community and connectedness between participants.
Book Club GroupBehavioural
A topical book club group discussing Autism-related material conducted by a single healthcare professional.
| Study group | Role | What they receive |
|---|---|---|
| Facebook Group | Experimental | Social skills training within an online group. Receives: Behavioral: Facebook Group |
| Book Club Group | Active comparator | An in-person Book Club discussing material related to Autism Spectrum Disorder. Receives: Behavioral: Book Club Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in social skills as assessed by Social Responsiveness Scale.
Measured: Week 1 and Week 8
Improvements in social skills as assessed by Social Skills Improvement System.
Measured: Week 1 and Week 8
Improvements in social skills as assessed by the Project Rex Parent Survey.
Measured: Week 1 and Week 8
Secondary outcomes (1)
Participant satisfaction as assessed by the Project Rex Connect Participant Survey.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionAug 2016
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 Medical University of South CarolinaThe 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897687
- Sponsor's protocol ID
- Pro00021530
- Acronym
- FBREX
- Status last verified
- May 2018
- First submitted
- 12 Aug 2016
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Rex Connect: The Utilization of an Online Social Network by an Interprofessional Team to Aid in Skill Acquisition for Patients With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02897687
- Acronym / sponsor ID
- FBREX / Pro00021530
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Social Skills, Social Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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.
Twelve participants were randomized to either a Facebook group or a book club group for six weeks. Data was collected on the participants social and behavioral function at both the start and the conclusion of the intervention.
Detailed description
Research Design
The Project Rex team will randomize up to 12 subjects with Autism Spectrum Disorder who have completed the Project Rex Teen Treatment Group into either:
- (Group F) A closed, invite-only group within Facebook facilitated by an interprofessional team that not only reinforces skills, but also aims to promote bonds and a sense of community and connectedness between participants.
OR
- (Group B) A topical book club group conducted by a single healthcare professional.
Both treatment arms will be 8 weeks in duration. The interprofessional team for the Facebook arm of treatment will consist of one child and adolescent psychiatrist, one psychologist, two social workers and one medical student. The single professional conducting the book club activity will be a medical student. Parents will be required to help facilitate their child's participation in the study treatment. All study subjects will have completed the 8-week social skills introduction to social conversation Project Rex Teen group immediately prior to enrolling in either the Facebook arm (F) or the Book Club arm (B) of the study.
Upon completion of this treatment cycle, the study investigators will conduct an additional treatment cycle by randomizing two additional groups, each comprising up to 12 subjects with Autism Spectrum Disorder who have completed the 8-week Project Rex Teen Treatment Group into either Group F or Group B. The investigators will therefore enroll up to 24 total subjects in the study. The study is being divided into three cycles due to the limitation of recruiting only subjects who have completed the most recent round of the Project Rex teen program. Approval by the Medical University of South Carolina Institutional Review Board will be obtained before beginning this pilot study.
Study Procedure
Patients participating in the Project Rex Teen Group and their parents will be provided with written and verbal information about the opportunity to enroll in this study. This information will be disseminated to patients and parents after the completion of five of the total eight weeks of the Project Rex Teen Group. Patients and their parents will have opportunities to ask questions about the study with co-investigators after the sessions on week 6 and week 7. After the 8-week Project Rex teen group concludes, study co-investigators will be available to obtain informed consent from the parents of the subjects ages 12 to 17 years of age, and to obtain the assent of the respective subjects. The study investigators will also be available to obtain the informed consent of subjects who are age 18 to 20 years at the conclusion of the 8-week Project Rex Teen Group. The parents and subjects will have up to seven days after the conclusion of Week 8 of the Project Rex Teen Group to provide their informed consent and assent, respectively, for enrollment in the study.
Once parents and subjects have provided their informed consent/assent and the subjects are enrolled in the study, each subject will be randomized using REDCap into either Group F (Facebook arm) or Group B (Book Club Arm). Both subject groups and their parents will meet with for an information session about the study and their participation, which will be scheduled to occur within a week of the conclusion of Week 8 of the Project Rex Teen Program. Both treatment groups will meet on the same day and time, but will attend different information sessions located in different rooms within the Institute of Psychiatry.
All subjects who are assigned to the Facebook group and their parents will meet for a 90-minute group information session at Week 1, prior to the start of the Facebook treatment phase. These meetings will be conducted by the study investigators and will include a review of the study procedure, Facebook guidelines and Facebook terms and policy, privacy settings and data collection methods. The study investigators will directly support each subject in setting up their project Rex Facebook account and educating subjects about privacy settings. The study investigators will provide parents with education and training on the use of the Project Rex Facebook account and the maintenance of Project Rex Facebook account privacy settings to ensure that subjects are using the account appropriately and safely. At the conclusion of the Facebook information session, the subjects will be randomly assigned via lottery into two groups (1 \& 2) for the purpose only of posting and responding to the discussion topic of the week.
All subjects and parents who are assigned to the Book Club group will meet for a 90-minute group information session at week 1, prior to the Book Club arm beginning. A study investigator will conduct this meeting and will provide a review of the study procedure, orient participants to the Book Club, review book club rules and expectations, and distribute the books.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facebook Group | Experimental | Behavioral: Facebook GroupSocial skills training within an online group. |
| Book Club Group | Active comparator | Behavioral: Book Club GroupAn in-person Book Club discussing material related to Autism Spectrum Disorder. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Clinical Diagnosis of Autism Spectrum Disorder
- Verbal
Key exclusion criteria (1 listed)
- Non-verbal
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 |
|---|---|---|
| Facebook GroupA closed, invite-only group within Facebook facilitated by an interprofessional team that not only reinforces skills, but also aims to promote bonds and a sense of community and connectedness between participants. | Behavioural | Facebook Group |
| Book Club GroupA topical book club group discussing Autism-related material conducted by a single healthcare professional. | Behavioural | Book Club Group |
Primary outcome
Improvements in social skills as assessed by Social Responsiveness Scale.
Time frame: Week 1 and Week 8
Improvements in social skills as assessed by Social Skills Improvement System.
Time frame: Week 1 and Week 8
Improvements in social skills as assessed by the Project Rex Parent Survey.
Time frame: Week 1 and Week 8
1 secondary outcome
Participant satisfaction as assessed by the Project Rex Connect Participant Survey.
Time frame: Week 8
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 9 May 2018.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facebook Group and Book Club Group in people with Autism Spectrum Disorder, run by Medical University of South Carolina 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 2 inclusion and 1 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 9 May 2018. 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?
Improvements in social skills as assessed by Social Responsiveness Scale. (time frame: Week 1 and Week 8). The study lists 3 primary outcomes in all. 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 9 May 2018.