- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07923370
Facial Expression Awareness Training to Understand and Recognize Emotions (FEATURE)
The FEATURE Study: Facial Expression Awareness Training to Understand and Recognize Emotions
The purpose of this research is to find out if a computer-based treatment program, called FaceSay, is a feasible and effective intervention for survivors of pediatric brain tumors (SPBT). The goal of this intervention is to improve survivors' facial affect recognition, social attention, and social adjustment.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
The proposed research is for a pilot randomized clinical trial (RCT) of a face processing intervention, FaceSay, compared to an active control condition in SPBT who demonstrate peer-related social difficulties that are similar to autistic youth. Using a randomized, active control trial with a 1:1: randomization, this study will evaluate the feasibility and acceptability of the intervention with SPBT and estimate the effects of the program on key social functioning domains. Participants will be randomized into either the FaceSay condition or an active control condition, SuccessMaker, which is an online academic skill-building program. Participants will be evaluated at baseline prior to the intervention (T1), immediately after the intervention (T2), and 3 months later (T3). The study duration per subject will be approximately 18 weeks including 3 in-person study visits and the 6-week intervention period. This is a single-site study with all potential participants being recruited from the Neuro-Oncology program at the Children's Hospital of Philadelphia (CHOP). The goal is to randomize 40 participants in this pilot study.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Matthew Hocking, PhD (Clinical Psychology)
- Telefonszám: 267-426-5561
- E-mail: hockingm@chop.edu
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Manali Zope, BS (Biological Sciences)
- Telefonszám: 267-425-0174
- E-mail: zopem@chop.edu
Tanulmányi helyek
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Pennsylvania
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Philadelphia, Pennsylvania, Egyesült Államok, 19335
- Toborzás
- Children's Hospital of Philadelphia
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Kapcsolatba lépni:
- Manali Zope, BS (Biological Sciences)
- Telefonszám: 267-425-0174
- E-mail: zopem@chop.edu
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Kutatásvezető:
- Matthew Hocking, PhD (Clinical Psychology)
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
Eligible participants are SPBT who:
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are between the ages 6-13
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completed some form of tumor-directed treatment (surgery, chemotherapy, and/or radiation therapy)
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are off tumor-directed therapy
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demonstrate difficulties on at least one of the following:
- Parent- or self-rated Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships Short Form: T-score 1 standard deviation below the mean, which translates to T scores of 40 or below
- Social Responsiveness Scale-2 (SRS-2): T-score above 60 on any scale
- Child Behavior Checklist (CBCL): T-score below 30 on social competence scale or T-score above 64 on social problems subscale
Exclusion Criteria:
Ineligible participants are individuals who:
- have a genetic condition affecting neurocognitive or social function, or severe developmental delays (excluding NF1, ASD, and Moya Moya)
- are non-English speaking (FaceSay is only available in English and some assessments only have been validated in English)
4) a motor or visual limitation that precludes computer use
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: FaceSay
Beginning within two weeks of baseline testing, participants will be asked to complete two 20-minute sessions of FaceSay per week for 6 weeks (12 sessions total), which is identical to prior FaceSay trials. Research staff will conduct brief, weekly phone or telehealth-based check-ins during training to monitor progress and discuss strategies to support engagement with the programs. |
FaceSay (http://www.facesay.com/) is a computer-delivered, software program to enhance face processing in youth, a core component of social information processing (SIP). The training occurs in a game-like environment that repeatedly challenges different aspects of face processing. FaceSay contains three different games that target various skills. "Amazing Gazing" targets users' eye gaze and joint attention and requires users to respond based on the game character's eye gaze. In the game "Band Aid Clinic," users reconstruct a game character's face by applying the correct band aid that includes pictures of facial features. This game promotes processing of facial expressions through different facial features and configurations. The final game, "Follow the Leader," requires users to match facial expressions from one game character to another. As the user advances, the facial expressions become increasingly subtle and more challenging. |
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Aktív összehasonlító: SuccessMaker Reading
Beginning within two weeks of baseline testing, participants will be asked to complete two 20-minute sessions of SuccessMaker Reading per week for 6 weeks (12 sessions total), which is identical to prior FaceSay trials. Research staff will conduct brief, weekly phone or telehealth-based check-ins during training to monitor progress and discuss strategies to support engagement with the programs. |
SuccessMaker: SuccessMaker is an online, academic skills building program. Using adaptive lessons tailored to the participant's reading level, SuccessMaker aims to enhance understanding in phonological awareness, phonics, fluency, vocabulary, comprehension, and concepts of print. The program adapts to the performance of the user across areas to introduce new skills when appropriate to the user. SuccessMaker targets different domains than by FaceSay and those not associated with social difficulties. SuccessMaker uses adaptive lessons tailored to the participant's reading level to enhance understanding in phonological awareness, phonics, fluency, vocabulary, comprehension, and concepts of print. The program adapts to the performance of the user across areas to introduce new skills when appropriate to the user. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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FaceSay Feasibility and Acceptability: Enrollment Rates
Időkeret: Across recruitment outreach period, up to 5 no-response contacts
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Survivors and families will demonstrate interest in FaceSay, as defined by at least 75% of those approached enrolling in the study. |
Across recruitment outreach period, up to 5 no-response contacts
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FaceSay Feasibility and Acceptability: Training Completion Rate
Időkeret: Training completion will be tracked for each participant across 6 weeks. A final completion rate for each participant will be calculated at the end of the 6-week period.
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FaceSay will be feasible, as defined by 75% of randomized participants achieving over 80% treatment adherence (i.e., 10 of 12 training sessions over a 6-week period). |
Training completion will be tracked for each participant across 6 weeks. A final completion rate for each participant will be calculated at the end of the 6-week period.
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FaceSay Feasibility and Acceptability: Intervention Acceptability
Időkeret: Parent reports of the intervention across their 6-week training period will be assessed at their T2 follow-up visit.
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FaceSay will be acceptable, as defined by family reports of ease-of-use and satisfaction. |
Parent reports of the intervention across their 6-week training period will be assessed at their T2 follow-up visit.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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FaceSay Efficacy: Facial Identity Recognition Improvement
Időkeret: Enrollment to T3 (18 weeks)
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At each time point, participants will be asked to complete the Victoria/Yale face processing assessment, which tests facial identity recognition skills. Overall accuracy scores (ranging from 0-100) for the facial identity recognition task will be used to quantify these skills, with higher scores reflecting better facial identity recognition. |
Enrollment to T3 (18 weeks)
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FaceSay Efficacy: Social Attention Improvement
Időkeret: Enrollment to T3 (18 weeks)
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At each time point, participants doing in-person visits will complete a social attention paradigm that uses eye-tracking technology to capture the child's attention during a video of children playing. This task measures eye gaze during thirty-two 15-second videos depicting pairs of siblings engaging in either joint, cooperative or separate, parallel play. A Social Prioritization score will be calculated by subtracting the proportion of fixation time for background objects from the proportion of fixation time for faces. Higher Social Prioritization scores indicate more looking at faces and less looking at background objects. This task will only be completed for in-person study visits as it requires the use of a physical eye tracking device. |
Enrollment to T3 (18 weeks)
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FaceSay Efficacy: Social Deficits Improvement
Időkeret: Enrollment to T3 (18 weeks)
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At each time point, caregivers of participants will complete the Social Responsiveness Scale, 2nd Edition (SRS- 2). The SRS-2 is a 65-item parent-report questionnaire that evaluates the frequency of reciprocal social behaviors, communication, and repetitive and stereotypic behaviors in the child. The school-age form (for ages 4-18 years) will be used. The questionnaire yields a single summary T-score that can be used as an index of the child's severity of social deficits, with higher scores indicating greater deficits. |
Enrollment to T3 (18 weeks)
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FaceSay Efficacy: Facial Expression Recognition Improvement
Időkeret: Enrollment to T3 (18 weeks)
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At each time point, participants will be asked to complete the Victoria/Yale face processing assessment, which tests facial expression recognition skills. Overall accuracy scores (ranging from 0-100) for the facial expression recognition task will be used to quantify these skills, with higher scores reflecting better facial identity recognition. |
Enrollment to T3 (18 weeks)
|
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FaceSay Efficacy: Social Functioning Improvement
Időkeret: Enrollment to T3 (18 weeks)
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At each time point, caregivers and youth will complete the Pediatric Quality of Life Inventory 4.0 (PedsQL). The PedsQL 4.0 is a 23-item measure broken down by participant age that examines physical, social, emotional, and school functioning over the past month. Scores from the social functioning sub-domain (ranging from 0-100) will be used to quantify social functioning, with higher scores indicating better social functioning. |
Enrollment to T3 (18 weeks)
|
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FaceSay Efficacy: Peer Relationship Improvement
Időkeret: Enrollment to T3 (18 weeks)
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At each time point, caregivers and youth will complete the Patient Reported Outcomes Measurement Information System (PROMIS) Peer Relationships questionnaire. The PROMIS Peer Relationships questionnaire assesses the quality of the child's peer relationships. Overall T-scores for the measure will be assessed, with higher scores indicating better peer relationship quality. |
Enrollment to T3 (18 weeks)
|
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FaceSay Efficacy: Social Functioning Improvement
Időkeret: Enrollment to T3 (18 weeks)
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At each time point, caregivers will complete the Childhood Behavioral Checklist (CBCL). The CBCL is a parent-report that evaluates a variety of behaviors in children including activities, school performance, and social interactions. T-scores from the social competence subdomain will be used to quantify social functioning, with higher scores reflecting better social functioning. |
Enrollment to T3 (18 weeks)
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FaceSay Efficacy: Social Information Processing
Időkeret: Enrollment to T3 (18 weeks)
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At each time point, participants will complete the attribution and coping questionnaire which assess the child's attribution of peer's behaviors during hypothetical, ambiguous social interactions and their coping response. The percent of time the child choses each attribution and coping style will be assessed, and group differences in dominant styles will be assessed. |
Enrollment to T3 (18 weeks)
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Publikációk és hasznos linkek
Általános kiadványok
- Ostrom QT, Cioffi G, Gittleman H, Patil N, Waite K, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2012-2016. Neuro Oncol. 2019 Nov 1;21(Suppl 5):v1-v100. doi: 10.1093/neuonc/noz150.
- Vannatta K, Gartstein MA, Short A, Noll RB. A controlled study of peer relationships of children surviving brain tumors: teacher, peer, and self ratings. J Pediatr Psychol. 1998 Oct;23(5):279-87. doi: 10.1093/jpepsy/23.5.279.
- Hocking MC, McCurdy M, Turner E, Kazak AE, Noll RB, Phillips P, Barakat LP. Social competence in pediatric brain tumor survivors: application of a model from social neuroscience and developmental psychology. Pediatr Blood Cancer. 2015 Mar;62(3):375-84. doi: 10.1002/pbc.25300. Epub 2014 Nov 8.
- Desjardins L, Barrera M, Chung J, Cataudella D, Janzen L, Bartels U, Downie A, Fairclough D. Are we friends? Best friend nominations in pediatric brain tumor survivors and associated factors. Support Care Cancer. 2019 Nov;27(11):4237-4244. doi: 10.1007/s00520-019-04706-3. Epub 2019 Mar 8.
- King AA, Seidel K, Di C, Leisenring WM, Perkins SM, Krull KR, Sklar CA, Green DM, Armstrong GT, Zeltzer LK, Wells E, Stovall M, Ullrich NJ, Oeffinger KC, Robison LL, Packer RJ. Long-term neurologic health and psychosocial function of adult survivors of childhood medulloblastoma/PNET: a report from the Childhood Cancer Survivor Study. Neuro Oncol. 2017 May 1;19(5):689-698. doi: 10.1093/neuonc/now242.
- Brinkman TM, Ness KK, Li Z, Huang IC, Krull KR, Gajjar A, Merchant TE, Klosky JL, Partin RE, Tonning Olsson I, Boop F, Klimo P Jr, Chemaitilly W, Khan RB, Srivastava D, Robison LL, Hudson MM, Armstrong GT. Attainment of Functional and Social Independence in Adult Survivors of Pediatric CNS Tumors: A Report From the St Jude Lifetime Cohort Study. J Clin Oncol. 2018 Sep 20;36(27):2762-2769. doi: 10.1200/JCO.2018.77.9454. Epub 2018 Aug 9.
- Rice LM, Wall CA, Fogel A, Shic F. Computer-Assisted Face Processing Instruction Improves Emotion Recognition, Mentalizing, and Social Skills in Students with ASD. J Autism Dev Disord. 2015 Jul;45(7):2176-86. doi: 10.1007/s10803-015-2380-2.
- Hopkins IM, Gower MW, Perez TA, Smith DS, Amthor FR, Wimsatt FC, Biasini FJ. Avatar assistant: improving social skills in students with an ASD through a computer-based intervention. J Autism Dev Disord. 2011 Nov;41(11):1543-55. doi: 10.1007/s10803-011-1179-z.
- Hocking MC, Parish-Morris J, Schultz RT, Minturn JE, Brodsky C, Shabason EK, Herrington JD. Diminished social attention in pediatric brain tumor survivors: Using eye tracking technology during naturalistic social perception. Neuropsychology. 2020 Mar;34(3):350-358. doi: 10.1037/neu0000623. Epub 2020 Jan 30.
- Moxon-Emre I, Farb NAS, Oyefiade AA, Bouffet E, Laughlin S, Skocic J, de Medeiros CB, Mabbott DJ. Facial emotion recognition in children treated for posterior fossa tumours and typically developing children: A divergence of predictors. Neuroimage Clin. 2019;23:101886. doi: 10.1016/j.nicl.2019.101886. Epub 2019 Jun 12.
- Hocking MC, Schultz RT, Minturn JE, Brodsky C, Albee M, Herrington JD. Reduced Fusiform Gyrus Activation During Face Processing in Pediatric Brain Tumor Survivors. J Int Neuropsychol Soc. 2022 Oct;28(9):937-946. doi: 10.1017/S135561772100117X. Epub 2021 Oct 4.
- Hocking MC, Noll RB, Kazak AE, Brodsky C, Phillips P, Barakat LP. Friendships in Pediatric Brain Tumor Survivors and Non-Central Nervous System Tumor Survivors. J Pediatr Psychol. 2020 Mar 1;45(2):194-202. doi: 10.1093/jpepsy/jsz101.
- Fantozzi PM, Anil A, McHugh S, Srsich AR, Zope M, Parish-Morris J, Schultz RT, Herrington J, Hocking MC. Social impairment in survivors of pediatric brain tumors via reduced social attention and emotion-specific facial expression recognition. Pediatr Blood Cancer. 2024 Jun;71(6):e30943. doi: 10.1002/pbc.30943. Epub 2024 Mar 12.
- Yeates KO, Bigler ED, Dennis M, Gerhardt CA, Rubin KH, Stancin T, Taylor HG, Vannatta K. Social outcomes in childhood brain disorder: a heuristic integration of social neuroscience and developmental psychology. Psychol Bull. 2007 May;133(3):535-56. doi: 10.1037/0033-2909.133.3.535.
- Hocking MC, Albee M, Brodsky C, Shabason E, Wang L, Schultz RT, Herrington J. Face Processing and Social Functioning in Pediatric Brain Tumor Survivors. J Pediatr Psychol. 2021 Oct 18;46(10):1267-1275. doi: 10.1093/jpepsy/jsab067.
- Hocking MC, Quast LF, Brodsky C, Deatrick JA. Caregiver perspectives on the social competence of pediatric brain tumor survivors. Support Care Cancer. 2017 Dec;25(12):3749-3757. doi: 10.1007/s00520-017-3805-6. Epub 2017 Jul 8.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 25-023500
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
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