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통합 프로토콜: 커뮤니티 연결

2026년 9월 16일 업데이트: Jill May Ehrenreich, University of Miami

The purpose of this study is to administer the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) and Adolescents (UP-A) to youth and participants' parents and to examine the efficacy and outcomes of the treatment using standardized measures, questionnaires, interviews. The UP-C and the UP-A are cognitive-behavioral therapies to treat emotional disorders.

연구 개요

연구 유형

중재적

등록 (추정된)

1500

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

연구 연락처 백업

연구 장소

    • Florida
      • Coral Gables, Florida, 미국, 33146
        • 모병
        • Child and Adolescent Mood and Anxiety Treatment Program
        • 수석 연구원:
          • Jill Ehrenreich-May, PhD
        • 연락하다:
          • Jill Ehrenreich-May, PhD

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

7년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Children between the ages of 7-17.
  • Youth currently resides in Miami-Dade County.
  • Children and their parents must be able to speak and understand English and/or Spanish sufficiently well to complete study procedures (e.g., provide their informed consent/assent, complete assessment measures and/or program materials).
  • At least one parent or caregiver with whom the child is living with that can accompany the child and participate in all visits (assessment and treatment).
  • Positive endorsement of elevated emotional concerns in one of a limited range of emotional disorder domains (i.e., anxiety, depression, trauma, or obsessive-compulsive symptoms, etc.) during full DIAMOND-Kid semi-structured interview, and/or elevated anxiety or depression symptoms (T-Score > or = 65 for youth 8-17 years old; Raw score > or = 12 for children under 8 years old) on the Revised Child Anxiety and Depression Scale - Short Form (RCADS-SF; Child or Parent Report).
  • Youth with other types of comorbid conditions (e.g., tic/Tourette's disorder, eating disorders, or disruptive behavior disorders) will not be excluded, providing a clinical area of concern is regarding one of the emotional disorder domains specified and treatment within this protocol is deemed most appropriate.
  • Youth and parent participation in at least one in-person session if the treatment is predominantly delivered virtually.

Exclusion Criteria:

  • Prior receipt of at least 8 sessions of the UP-C/A program at the Child and Adolescent Mood and Anxiety Treatment Program (CAMAT).
  • Psychiatric hospitalization in the previous 6 months (i.e., due to Baker Act, psychotic symptoms, significant suicidal ideation, danger to self or others, etc.).
  • Another significant problem area that takes priority for services (e.g., eating disorder, substance-use disorder, primary externalizing concerns, psychotic symptoms, etc.), as identified by family report or via DIAMOND-Kid interview.
  • Inability for family to wait for the next group treatment cohort to start, family declining therapist assignment following intake, and/or family no-showing to 3 or more scheduled sessions at CAMAT (inclusive of intake assessment).

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: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children

The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in up to 15 sessions through a group format, attended over up to 24 weeks. Sessions will include parent and child strategies to manage strong emotions.

The UP-C is administered in-person to parents and children over the course of up to 15 weekly group sessions, which last approximately 90 minutes each.

다른 이름들:
  • UP-C
실험적: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents

The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in an individual format for up to 24 weeks.

The UP-A is administered to parents and teens over the course of approximately 15-24 weekly individual sessions, which last approximately 50 minutes each. Sessions can be administered in-person or online, with at least one session occurring in person.

다른 이름들:
  • 업에이

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-S)
기간: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).

The Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-25) is 25-item parent-reported scale measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with total composite score ranging from 0 to 75. A score of 70 or higher indicates high severity.

Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S)
기간: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).

The Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-25) is 25-item self-reported scale measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with total composite scores ranging from 0 to 75. A score of 70 or higher indicates high severity.

Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Change in Strengths and Difficulties Questionnaire - Parent Version (SDQ-P)
기간: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).

The Strengths and Difficulties Questionnaire (SDQ) is a 25-item parent-reported measure assessing five domains in youth: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and pro-social behaviors. All items are rated on a 3-point scale from 0 (not true) to 2 (Certainly true). A score can be generated for each scale and all except the prosocial subscale are added together to generate a total composite difficulties score (based on 20 items). Higher total scores are indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behavior.

Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Change in Strengths and Difficulties Questionnaire - Child Version (SDQ-C)
기간: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).

The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-reported measure assessing five domains in youth: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and pro-social behaviors. All items are rated on a 3-point scale from 0 (not true) to 2 (Certainly true). A score can be generated for each scale and all except the prosocial subscale are added together to generate a total composite difficulties score (based on 20 items). Higher total composite scores are indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behavior.

Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Change in Parental Stress Scale (PSS) as measured by Likert Scale
기간: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).

The Parental Stress Scale (PSS) is an 18-item measure assessing parents' feelings about their parenting role, exploring both positive (e.g., emotional benefits, personal development) and negative (e.g., demands on resources, feelings of stress) aspects on parenthood. All items are rated on 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). Items are summed with higher scores indicating higher levels of parental stress.

Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).

2차 결과 측정

결과 측정
측정값 설명
기간
Top Problems Assessment - Parent Report as measured by Likert Scale
기간: up to 24 weeks

The Top Problems assessment is used to identify parent-reported target problems for treatment and track changes in problem severity over time. Identified top problem statements are rated on 9-point Likert scale from 0 (not at all a problem) to 8 (a huge problem).

up to 24 weeks
Top Problems Assessment - Child Report as measured by Likert Scale
기간: up to 24 weeks

The Top Problems assessment is used to identify self-reported target problems for treatment and track changes in problem severity over time. Identified top problem statements are rated on 9-point Likert scale from 0 (not at all a problem) to 8 (a huge problem).

up to 24 weeks
Change in Clinical Global Impression, Severity Scale (CGI-S)
기간: At baseline, and up to 24 weeks

The CGI-S is a single-item clinician-reported measure used to assess the severity of the youth's illness at the time of assessment. The item is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom severity.

At baseline, and up to 24 weeks
Clinical Global Impression - Improvement (CGI-I)
기간: At up to 24 weeks

The CGI-I is a single-item clinician-reported measure used to assess clinical changes in youth symptomology over the course of treatment. The item is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom improvement since baseline.

At up to 24 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Jill Ehrenreich-May, PhD, University of Miami

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

  • Ehrenreich-May, J., Kennedy, S. M., Sherman, J. A., Bilek, E. L., Buzzella, B. A., Bennett, S. M., & Barlow, D. H. (2017). Unified protocols for transdiagnostic treatment of emotional disorders in children and adolescents: Therapist guide. Oxford University Press.

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)

2023년 9월 25일

기본 완료 (추정된)

2028년 9월 1일

연구 완료 (추정된)

2028년 9월 25일

연구 등록 날짜

최초 제출

2023년 9월 7일

QC 기준을 충족하는 최초 제출

2023년 9월 8일

처음 게시됨 (실제)

2023년 9월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 16일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 20230860

개별 참가자 데이터(IPD) 계획

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아니요

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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. .

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