Facebook for Social Skills Training in Autism: Project Rex Connect (FBREX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02897687|
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Facebook Group Behavioral: Book Club Group||Not Applicable|
Hide Detailed Description
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.
- (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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||August 2016|
Experimental: Facebook Group
Social skills training within an online group.
Behavioral: Facebook Group
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.
Active Comparator: Book Club Group
An in-person Book Club discussing material related to Autism Spectrum Disorder.
Behavioral: Book Club Group
A topical book club group discussing Autism-related material conducted by a single healthcare professional.
- 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 ]
- Participant satisfaction as assessed by the Project Rex Connect Participant Survey. [ Time Frame: Week 8 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897687
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|