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Идёт набор NCT05685368

Acceptance and Commitment Therapy for Adolescents and Young Adults With Sickle Cell Disease

Фаза I / Фаза II С лечением Race-related Stress Depression, Anxiety Quality of Life Stress Reaction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ACT for SCD.
Кому может быть актуально
Состояния в реестре: Race-related Stress, Depression, Anxiety, Quality of Life, Stress Reaction. Базовые параметры: 14 лет — 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Using Acceptance and Commitment Therapy (ACT) to Promote Mental Health and Transition Readiness in Youth With Sickle Cell Disease: A Community-Based Participatory Action Research (CBPAR) Approach

Обзор

The current study seeks to build on previous research that demonstrates the efficacy of Acceptance and Commitment Therapy in combating stigma by investigating the feasibility and acceptability of a protocol to support Black adolescents and young adults in coping with race related stress. The study will consist of a small, purposeful, non-randomized sample (N = 30) of clients enrolled into a 10-session Acceptance and Commitment Therapy group. The group will be offered as part of regular clinical care at the Division of Adolescent and Young Adult Medicine. Three consecutive groups will be run with approximately 8-10 participants in each group over the next year.

Вмешательства

  • Поведенческое ACT for SCD
    Phase I Using a convenience sample, this study examines the feasibility and acceptability of a proposed 6-session ACT group intervention for Black youth with sickle cell disease (SCD), who experience compounded stress due to chronic illness and systemic inequities. A up to 11 youth and up to 11 parents/legal guardians will be enrolled in an ACT group offered via the Division of Adolescent and Young Adult Medicine. Participants will complete assessments at pre-, and post-intervention, and at a 3-

Первичные конечные точки

  • Total Score on Index of Race-Related Stress (IRRS)-Brief Version [Срок оценки: 12 weeks]
  • Sickle Cell Self-Efficacy Scale [Срок оценки: 6 mos]
  • SCD Health-Related Internalized Stigma Scale [Срок оценки: 6 mos]
  • Transition Readiness Assessment Questionnaire (TRAQ), [Срок оценки: 6 mos]
Вторичные конечные точки (4)
  • Total Scores on Acceptance and Action Questionnaire-2 [Срок оценки: 12 weeks]
  • Total Scores on Multidimensional Inventory of Black Identity-Teen (MIBI-t) [Срок оценки: 12 weeks]
  • Total Score on Patient Health Questionaire-9 [Срок оценки: 12 weeks]
  • Total Score on General Anxiety Disorder-7 [Срок оценки: 12 weeks]

Критерии участия

Youth Participant Inclusion and Exclusion Criteria The inclusion criteria for study participation are Be an adolescent and/or young adult (age 14-21) who has Sickle Cell Disease Willing to enroll in the ACT group jointly provided by the Division of Adolescent and Young Adult Medicine/Department of Hematology and Oncology Participants can be active, waitlisted, or new patients at CHLA Participants must be able to understand and speak English, as the therapy will only be delivered in English Participants must have an English-speaking parent/guardian Able to provide consent/assent An adolescent or young adult that is pregnant is eligible to participate if consent can be obtained Participants must be developmentally typical Have a stable internet connection (via computer, tablet, or phone) with access to a webcam and a private space to engage in a group therapy sessions; Must consent to audio and video recording of initial interview. Must agree to attend 6 weekly ACT group session Youth participants will be asked to become a member of the CAB. To become a CAB member, the youth participant must consent/assent to participation in the ACT intervention. If a CAB member, they must be willing to engage in CAB interviews and meetings.

The exclusion criteria are:

Prisoners or youth in detention centers Unable to understand or speak English Does not have SCD Clients who are at significant risk for suicide and self-injury will be excluded due to the intense levels of support required to support these individuals which would interfere with study procedures.

Adolescents with families that require frequent intervention from the Department of Children and Family Services, are currently experiencing psychosis, or have severe health concerns that will impact study participation or attendance will be excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT05685368 · CHLA-25-00201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗