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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT02897687
Study groupRoleWhat they receive
Facebook GroupExperimentalSocial skills training within an online group.
Receives: Behavioral: Facebook Group
Book Club GroupActive comparatorAn 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.

  1. Improvements in social skills as assessed by Social Responsiveness Scale.

    Measured: Week 1 and Week 8

  2. Improvements in social skills as assessed by Social Skills Improvement System.

    Measured: Week 1 and Week 8

  3. Improvements in social skills as assessed by the Project Rex Parent Survey.

    Measured: Week 1 and Week 8

Secondary outcomes (1)
  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.

  1. First posted13 Sep 2016 (estimated)
  2. Study startApr 2013
  3. Primary completionJun 2014
  4. Study completionAug 2016

Resources

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)
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

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.

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