NCT05142605招募中不适用
Meaning-Centered Grief Therapy for Parents Bereaved by Cancer: A Multisite Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 415
- 试验地点
- 5
- 主要终点
- Change in Prolonged Grief Disorder-13-R (PG-13-R) scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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?
- 另有 21 项未显示
排除标准
- •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
研究组 & 干预措施
Cohort 1: Meaning-Centered Grief Therapy (MCGT)
Experimental
Participants will receive the MCGT intervention for approximately 4 months or longer as needed.
干预措施: Meaning-Centered Grief Therapy (Behavioral)
Group 2: Supportive Psychotherapy (SP)
Active Comparator
Participants will receive the SP intervention for approximately 4 months or longer as needed.
干预措施: Supportive Psychotherapy (Behavioral)
Group 3: Enhanced usual care (EUC)
Active Comparator
Participants will receive EUC for approximately 4 months or longer as needed.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Change in Prolonged Grief Disorder-13-R (PG-13-R) scores
时间窗: Baseline up to 10 months
The Prolonged Grief-13-Revised (PG-13-R) is a 13-item self-report scale evaluating the proposed symptoms of prolonged grief disorder. The PG-13-R assesses the severity of 10 grief-related symptoms using a 5-point Likert-type scale. Additional items evaluate the experience of a significant loss, symptom duration, and functional impairment. The PG-13-R yields a score between 10 and 50, where a higher score indicates that a person experiences higher levels of prolonged grief.
Change in Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) score
时间窗: Baseline up to 10 months
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) is a 20-item self-report measure assessing the frequency of depressive symptoms in the past week on a 4-point scale. Total scores range from 0 to 60, with scores above 16 indicating possible clinically significant depression levels.
次要结局
- Change in Prolonged Grief Disorder - Clinical Global Impressions Scale - Severity and Improvement Items (PGD-CGI) ratings(Baseline up to 10 months)
- Change in State-Trait Anxiety Inventory - Short Form (STAI-SF) scores(Baseline up to 10 months)
- Change in Presence of Regret Scale scores(Baseline up to 10 months)
- Change in Continuing Bonds Scale (CBS) scores(Baseline up to 10 months)
- Change in Beck Hopelessness Scale - Short Form (BHS-SF) scores(Baseline up to 10 months)
- Change in PROMIS: Global Health Scale (PROMIS-GH) scores(Baseline up to 10 months)
- Change in Posttraumatic Growth Inventory - Short Form (PTGI-SF) scores(Baseline up to 10 months)
研究者
Wendy G. Lichtenthal
Associate Professor, Pending Rank
University of Miami
研究点 (5)
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