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Facial Expression Awareness Training to Understand and Recognize Emotions (FEATURE)

2. listopadu 2026 aktualizováno: Children's Hospital of Philadelphia

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Matthew Hocking, PhD (Clinical Psychology)
  • Telefonní číslo: 267-426-5561
  • E-mail: hockingm@chop.edu

Studijní záloha kontaktů

  • Jméno: Manali Zope, BS (Biological Sciences)
  • Telefonní číslo: 267-425-0174
  • E-mail: zopem@chop.edu

Studijní místa

    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy, 19335
        • Nábor
        • Children's Hospital of Philadelphia
        • Kontakt:
          • Manali Zope, BS (Biological Sciences)
          • Telefonní číslo: 267-425-0174
          • E-mail: zopem@chop.edu
        • Vrchní vyšetřovatel:
          • Matthew Hocking, PhD (Clinical Psychology)

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

6 let až 13 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

Eligible participants are SPBT who:

  1. are between the ages 6-13

  2. completed some form of tumor-directed treatment (surgery, chemotherapy, and/or radiation therapy)

  3. are off tumor-directed therapy

  4. demonstrate difficulties on at least one of the following:

    1. 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
    2. Social Responsiveness Scale-2 (SRS-2): T-score above 60 on any scale
    3. 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:

  1. have a genetic condition affecting neurocognitive or social function, or severe developmental delays (excluding NF1, ASD, and Moya Moya)
  2. 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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.

Aktivní komparátor: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
FaceSay Feasibility and Acceptability: Enrollment Rates
Časové okno: Across recruitment outreach period, up to 5 no-response contacts

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
FaceSay Feasibility and Acceptability: Training Completion Rate
Časové okno: 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.

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.
FaceSay Feasibility and Acceptability: Intervention Acceptability
Časové okno: Parent reports of the intervention across their 6-week training period will be assessed at their T2 follow-up visit.

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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
FaceSay Efficacy: Facial Identity Recognition Improvement
Časové okno: Enrollment to T3 (18 weeks)

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)
FaceSay Efficacy: Social Attention Improvement
Časové okno: Enrollment to T3 (18 weeks)

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)
FaceSay Efficacy: Social Deficits Improvement
Časové okno: Enrollment to T3 (18 weeks)

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)
FaceSay Efficacy: Facial Expression Recognition Improvement
Časové okno: Enrollment to T3 (18 weeks)

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)
FaceSay Efficacy: Social Functioning Improvement
Časové okno: Enrollment to T3 (18 weeks)

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)
FaceSay Efficacy: Peer Relationship Improvement
Časové okno: Enrollment to T3 (18 weeks)

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)
FaceSay Efficacy: Social Functioning Improvement
Časové okno: Enrollment to T3 (18 weeks)

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)
FaceSay Efficacy: Social Information Processing
Časové okno: Enrollment to T3 (18 weeks)

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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spolupracovníci

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

30. října 2025

Primární dokončení (Odhadovaný)

1. srpna 2027

Dokončení studie (Odhadovaný)

1. prosince 2027

Termíny zápisu do studia

První předloženo

5. října 2026

První předloženo, které splnilo kritéria kontroly kvality

2. listopadu 2026

První zveřejněno (Aktuální)

6. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 25-023500

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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