Food Allergy in Children Clinical Trial
— F3A-AppOfficial title:
Friends, Family and Food: Interactive Virtual Environments for Children With Food Allergies - II
Verified date | May 2021 |
Source | Rhode Island Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: This Phase II STTR grant incorporated user feedback collected in an earlier development project to build interactive, web-based software that helps children with food allergies learn about their condition and gain self-management skills. This highly interactive game allows children to progress through virtual scenes to help them learn about food avoidance, symptom detection, and reaction management. In addition, this project built gaming complexity, with more levels and game options, of the two interactive games "Label Learning: Like it or Lose it!" and "Reaction Action!." Research Procedures: The researchers elicited input from 8 families of children (ages 8-12) with food allergies and their parents by presenting some of preliminary intervention materials (e.g., storyboards of a child in a family gathering involving food) in a focus group format. After that, up to 40 families of children with food allergies (ages 8-12) were recruited to participate in an "open trial". Families were asked to use the software for two weeks and provide feedback on the software. Up to 100 families of children with food allergies (ages 8-12) were then recruited to participate in a Randomized Clinical Trial (RCT) to assess the efficacy of the F3A-App vs. Standard Care (brief office visit and educational handouts). Families in the clinical trial were asked to use the software for two weeks and complete a standard care allergy office visit. This design enabled the investigators to evaluate combined effects of Standard Care and the F3A-App through typical treatment channels (e.g., is the greatest efficacy found after a physician refers family to use the App after an office visit?). Gains in families' knowledge and confidence in food allergy management were evaluated, and interviews with families were conducted to gain further input regarding the software's credibility, usability, and acceptability. This entry describes only the RCT portion of this Phase II STTR project.
Status | Completed |
Enrollment | 80 |
Est. completion date | May 19, 2017 |
Est. primary completion date | May 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 12 Years |
Eligibility | Inclusion Criteria: 1. child must be 8-12 2. child must have an active diagnosis of FA, confirmed by a physician 3. child and parent must speak and read English 4. child must have access to a computer with internet access 5. child must have access to a smartphone or table Exclusion Criteria: any chronic health condition requiring substantial dietary self-management (e.g., diabetes) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Rhode Island Hospital | Virtually Better, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acceptability of the Friends, Family and Food App (F3-App): Technology Post-Trial Impressions Questionnaire | Standard user experience questions were adapted to elicit feedback from study participants regarding the logic of F3-App, participants' confidence in their FA treatment, and whether they would recommend the F3-App to others. Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. . Journal of Behavior Therapy & Experimental Psychiatry, 3, 257-260. 31. Silverman, W. K., Kurtines, W. M., Ginsburg, G. S., Weems, C. F., Lumpkin, P. W., & Carmichael, D. H.
(1999). Treating anxiety disorders in children with group cognitive-behaviorial therapy: a randomized clinical trial. J Consult Clin Psychol, 67(6), 995-1003. 32. Witmer, B. G., & Singer, M. J. (1998). Measuring Presence in Virtual Environments: A Presence Questionnaire. Presence: Teleoperators and Virtual Environments, 7(3), 225-240. |
Follow up (after use of the F3-App; approximately 8 week after baseline) | |
Other | Credibility of the F3-App: Technology Post-Trial Impressions Questionnaire | Degree of realism (visuals, audio) and participants' game interest were evaluated using items adapted from standard user experience measures. Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. . Journal of Behavior Therapy & Experimental Psychiatry, 3, 257-260. 31. Silverman, W. K., Kurtines, W. M., Ginsburg, G. S., Weems, C. F., Lumpkin, P. W., & Carmichael, D. H.
(1999). Treating anxiety disorders in children with group cognitive-behaviorial therapy: a randomized clinical trial. J Consult Clin Psychol, 67(6), 995-1003. 32. Witmer, B. G., & Singer, M. J. (1998). Measuring Presence in Virtual Environments: A Presence Questionnaire. Presence: Teleoperators and Virtual Environments, 7(3), 225-240. |
Follow up (after use of the F3-App; approximately 8 week after baseline) | |
Other | Adherence to the use of the F3-App during study | Percentage of completed modules & games | Follow up (after use of the F3-App; approximately 8 week after baseline) | |
Other | Food Allergy Caregiver-Child Communication | Caregiver & Child report versions. Eight yes/no questions about topics discussed between caregiver and child in previous week. | Baseline and Follow up (after use of the F3-App; approximately 8 week after baseline) | |
Primary | Change in Food Allergy Management Assessment Scale (FAMAS) scores | Semi-structured interview assessing various elements of food allergy (FA) management (caregiver and youth report). Domains of the scale are: FA knowledge, symptom assessment, family/child response to allergic reactions, family/child food avoidance, medication availability, alternate caregivers, parent/child anxiety related to FA, balanced integration of FA and family life. Higher scores on all scales indicate more optimal FA management. Klinnert, M.D., et al., Children's food allergies (FA): Development of the Food Allergy Management and Adaptation Scale (FAMAS). Journal of Allergy and Clinical Immunology, 2012. 129(AB299). | Change in various elements of FA management (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment) | |
Primary | Change in scores on the Food Allergy Independent Measure (FAIM) | The FAIM is a 4-item measure of anxiety related to the child's food allergy. Higher scores indicate a higher degree of anxiety. van der Velde J. L., Flokstra-de Blok B. M. J., Vlieg-Boerstra B. J., Oude Elberink G., DunnGalvin A., Hourihane J. B., Dubois A. E. J. (2010). Development validity and reliability of food allergy independent measure (FAIM). Allergy, 65, 630-635. doi: 10.1111/j.1398-9995.2009.02216.x | Change in FA-related anxiety (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment) | |
Primary | Change in scores on the Food Allergy Self-Efficacy | Self-efficacy related to self-treatment of Food Allergy (youth report). Higher scores indicate a higher level of self-efficacy. Bursch, B., et al., Construction and validation of four childhood asthma self-management scales: parent barriers, child and parent self-efficacy, and parent belief in treatment efficacy. J Asthma, 1999. 36(1): p. 115-28. | Change in self-efficacy related to self-tx of FA (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment) | |
Primary | Change in Food Allergy Knowledge scores | An assessment of the level of food allergy-related knowledge (youth report). Higher scores indicate better knowledge of FA. Sicherer, S.H., et al., Development and validation of educational materials for food allergy. Journal of Pediatrics, 2012. 160(4): p. 651-656. | Change in FA-related knowledge (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment) | |
Primary | Change in Parent-Child Communication related to Food Allergy | This measure was adapted from a parent-child communication assessment used to evaluate communication about sexual health. The Food Allergy adaptation evaluates the number of times parent and child discussed each of 6 FA management topics in prior week (e.g., using epinephrine) (caregiver and youth report). Huston, R.L. and L.J. Martin, Effect of a program to facilitate parent-chld communication about sex. Clinical Pediatrics, 1990. 29(11): p. 626-633.
45. Schuster, M.A., et al., Evaluation of talking parents, healthy teens, a new worksite based parenting programme to promote parent-adolescent communication about sexual health: randomised controlled data. BMJ, 2008. 337(a308). |
Change in amount of parent-child discussion related to FA (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment) |
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