Evaluation of Grief Therapy Approaches for Bereaved Parents

Официальное название

Meaning-Centered Grief Therapy for Parents Bereaved by Cancer: A Multisite Randomized Controlled Trial

Обзор

The purpose of this study is to compare three types of support programs for parents who have lost a child. The study will see how these support programs affect participants' grief and depression symptoms. The three support programs are called Meaning-Centered Grief Therapy, Supportive Counseling, and Enhanced Usual Care.

Вмешательства

• Поведенческое Meaning-Centered Grief Therapy
  Meaning-Centered Grief Therapy is a therapy that focuses on helping participants find a sense of meaning or purpose in participants' life after participants' loss. Parents will be provided (via mail or email) a workbook. This support program will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing.
• Поведенческое Supportive Psychotherapy
  Supportive Psychotherapy will help participants cope with participants' loss by giving them a place to express participants' feelings and providing participants with support during the sessions. Supportive counseling will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing.
• Поведенческое Enhanced Usual Care
  Enhanced usual care includes any support or resources participants may receive as part of participants' standard care (for example, therapy sessions with a local therapist), enhanced with additional resources.

Первичные конечные точки

• Change in Prolonged Grief Disorder-13-R (PG-13-R) scores [Срок оценки: Baseline up to 10 months]
• Change in Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) score [Срок оценки: Baseline up to 10 months]

Вторичные конечные точки (7)

• Change in PROMIS: Global Health Scale (PROMIS-GH) scores [Срок оценки: Baseline up to 10 months]
• Change in State-Trait Anxiety Inventory - Short Form (STAI-SF) scores [Срок оценки: Baseline up to 10 months]
• Change in Beck Hopelessness Scale - Short Form (BHS-SF) scores [Срок оценки: Baseline up to 10 months]
• Change in Presence of Regret Scale scores [Срок оценки: Baseline up to 10 months]
• Change in Posttraumatic Growth Inventory - Short Form (PTGI-SF) scores [Срок оценки: Baseline up to 10 months]
• Change in Continuing Bonds Scale (CBS) scores [Срок оценки: Baseline up to 10 months]
• Change in Prolonged Grief Disorder - Clinical Global Impressions Scale - Severity and Improvement Items (PGD-CGI) ratings [Срок оценки: Baseline up to 10 months]

Критерии участия

Parent Participant Inclusion Criteria:

• A biological, adoptive, step-parent or legal guardian from across the United States who lost a child diagnosed with cancer as indicated by self-report
• Age 18 or older as indicated by self-report
• Experienced the loss of a child diagnosed with cancer at least 6 months prior to enrollment as indicated by medical record or self-report
• Elevated prolonged grief (PG) symptoms (PG-13-R scores of 30 or above)
• Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
• English-speaking as per the language assessment items below and willing to receive the intervention in English
• What is the participant's preferred language?

°(Specify Lang)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

• How well does the participant speak English?

• Very well (PARTICIPANT IS ELIGIBLE)
• Well (PARTICIPANT is NOT ELIGIBLE)
• Not well (PARTICIPANT is NOT ELIGIBLE)
• Not at all (PARTICIPANT is NOT ELIGIBLE)
• Individuals who are pregnant per self-report are eligible to participate

Support Provider Inclusion Criteria:

• Must be age 18 or over as indicated by self-report
• Has been identified by the bereaved parent participant as a support or someone important to bereaved parent
• Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
• English-speaking as per the language assessment items below and willing to receive the intervention in English
• What is the participant's preferred language?

°(Specify Lang)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

• How well does the participant speak English?

• Very well (PARTICIPANT IS ELIGIBLE)
• Well (PARTICIPANT is NOT ELIGIBLE)
• Not well (PARTICIPANT is NOT ELIGIBLE)
• Not at all (PARTICIPANT is NOT ELIGIBLE)
• Individuals who are pregnant per self-report are eligible to participate.

Family Participant Inclusion Criteria:

• A biological, adoptive, step-parent or legal guardian from across the United States who lost a child diagnosed with cancer as indicated by self-report
• Age 18 or older as indicated by self-report
• Experienced the loss of a child diagnosed with cancer at least 6 months prior to enrollment as indicated by medical record or self-report
• Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
• English-speaking as per the language assessment items below and willing to receive the intervention in English
• What is the participant's preferred language?

°(Specify Lang)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

• How well does the participant speak English?

• Very well (PARTICIPANT IS ELIGIBLE)
• Well (PARTICIPANT is NOT ELIGIBLE)
• Not well (PARTICIPANT is NOT ELIGIBLE)
• Not at all (PARTICIPANT is NOT ELIGIBLE)
• Individuals who are pregnant per self-report are eligible to participate.

Training Case Inclusion Criteria:

• A biological, adoptive, step-parent, or legal guardian from across the United States as indicated by self-report
• Age 18 or older as indicated by self-report
• Experienced the loss of a child at least 6 months prior to enrollment as indicated by medical record or self-report
• Score of 29 or below on the PG-13-R OR lost a child to a cause other than cancer OR child's additional guardian has consented as a Parent Participant and has not provided permission to share participation status OR past participants who indicate an interest in serving as a training case and, in the judgment of the Principal Investigator, would be appropriate to enroll as a training case
• Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
• English-speaking as per the language assessment items below and willing to receive the intervention in English
• What is the participant's preferred language?

° (Specify Lang)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

• How well does the participant speak English?

• Very well (PARTICIPANT IS ELIGIBLE)
• Well (PARTICIPANT is NOT ELIGIBLE)
• Not well (PARTICIPANT is NOT ELIGIBLE)
• Not at all (PARTICIPANT is NOT ELIGIBLE)
• Individuals who are pregnant per self-report are eligible to participate.

Training Case Support Provider Inclusion Criteria:

• Must be age 18 or over as indicated by self-report
• Has been identified by the bereaved parent training case participant as a support or someone important to bereaved parent
• Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
• English-speaking as per the language assessment items below and willing to receive the intervention in English
• What is the participant's preferred language?

° (Specify Lang)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

• How well does the participant speak English?

• Very well (PARTICIPANT IS ELIGIBLE)
• Well (PARTICIPANT is NOT ELIGIBLE)
• Not well (PARTICIPANT is NOT ELIGIBLE)
• Not at all (PARTICIPANT is NOT ELIGIBLE)
• Individuals who are pregnant per self-report are eligible to participate.

Parent Participant Exclusion Criteria:

• Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent
• Inability to access a functional device for videoconferencing and declines offer to use a study loaner device as indicated by self-report
• Prisoners
• Participants unable to consent

Support Provider Exclusion Criteria:

• Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude informed consent
• Inability to access a computer with Internet as indicated by self-report
• Prisoners
• Participants unable to consent

Family Participant Exclusion Criteria:

• Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude informed consent
• Inability to access a computer with Internet as indicated by self-report
• Prisoners
• Participants unable to consent

Training Case Exclusion Criteria:

• Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent
• Inability to access a functional device for videoconferencing and declines offer to use a study loaner device as indicated by self-report
• Prisoners
• Participants unable to consent

Training Case Support Provider Exclusion Criteria

• Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude informed consent
• Inability to access a computer with Internet as indicated by self-report
• Prisoners
• Participants unable to consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Stanford University (Data Collection Only) — Stanford
• University of Miami — Miami
• Memorial Sloan Kettering Cancer Center — New York
• Children's Hospital of Philadelphia (Data Collection Only) — Philadelphia
• St Jude's Children's Hospital (Data collection only) — Memphis

Идентификаторы

NCT: NCT05142605 · 20230899 · R01NR019637

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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