RecruitingNot ApplicableNCT05142605
Evaluation of Grief Therapy Approaches for Bereaved Parents
Meaning-Centered Grief Therapy for Parents Bereaved by Cancer: A Multisite Randomized Controlled Trial
Sponsor
University of Miami
Enrollment
415 participants
Start Date
Mar 31, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria65
- 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
- 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.
- 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.
- 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.
- 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.
Exclusion Criteria20
- 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
- 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
- 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
- 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
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
BEHAVIORALMeaning-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.
BEHAVIORALSupportive 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.
BEHAVIORALEnhanced 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.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05142605
Related Trials
Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only
NCT0686770536 locations
EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer
NCT041414626 locations
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
NCT0683556910 locations
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
NCT072214091 location
Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S)
NCT065603981 location