이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 11월 2일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Matthew Hocking, PhD (Clinical Psychology)
  • 전화번호: 267-426-5561
  • 이메일: hockingm@chop.edu

연구 연락처 백업

  • 이름: Manali Zope, BS (Biological Sciences)
  • 전화번호: 267-425-0174
  • 이메일: zopem@chop.edu

연구 장소

    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19335
        • 모병
        • Children's Hospital of Philadelphia
        • 연락하다:
          • Manali Zope, BS (Biological Sciences)
          • 전화번호: 267-425-0174
          • 이메일: zopem@chop.edu
        • 수석 연구원:
          • Matthew Hocking, PhD (Clinical Psychology)

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

6년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
FaceSay Feasibility and Acceptability: Enrollment Rates
기간: 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
기간: 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
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
FaceSay Efficacy: Facial Identity Recognition Improvement
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 10월 30일

기본 완료 (추정된)

2027년 8월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2026년 10월 5일

QC 기준을 충족하는 최초 제출

2026년 11월 2일

처음 게시됨 (실제)

2026년 11월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다