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

2 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Matthew Hocking, PhD (Clinical Psychology)
  • Numer telefonu: 267-426-5561
  • E-mail: hockingm@chop.edu

Kopia zapasowa kontaktu do badania

  • Nazwa: Manali Zope, BS (Biological Sciences)
  • Numer telefonu: 267-425-0174
  • E-mail: zopem@chop.edu

Lokalizacje studiów

    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19335
        • Rekrutacyjny
        • Children's Hospital of Philadelphia
        • Kontakt:
          • Manali Zope, BS (Biological Sciences)
          • Numer telefonu: 267-425-0174
          • E-mail: zopem@chop.edu
        • Główny śledczy:
          • Matthew Hocking, PhD (Clinical Psychology)

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

6 lat do 13 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.

Aktywny komparator: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
FaceSay Feasibility and Acceptability: Enrollment Rates
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
FaceSay Efficacy: Facial Identity Recognition Improvement
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

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Sponsor

Współpracownicy

Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

30 października 2025

Zakończenie podstawowe (Szacowany)

1 sierpnia 2027

Ukończenie studiów (Szacowany)

1 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

5 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 listopada 2026

Pierwszy wysłany (Rzeczywisty)

6 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 25-023500

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .