NCT05142605 Evaluation of Grief Therapy Approaches for Bereaved Parents
| NCT ID | NCT05142605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Grief |
| Study Type | INTERVENTIONAL |
| Enrollment | 415 participants |
| Start Date | 2022-03-31 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 415 participants in total. It began in 2022-03-31 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Wendy G. Lichtenthal, PhD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT05142605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Grief. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05142605 currently recruiting?
Yes, NCT05142605 is actively recruiting participants. Contact the research team at wendy.lichtenthal@miami.edu for enrollment information.
Where is the NCT05142605 trial being conducted?
This trial is being conducted at Stanford, United States, Miami, United States, New York, United States, Philadelphia, United States and 1 additional location.
Who is sponsoring the NCT05142605 clinical trial?
NCT05142605 is sponsored by University of Miami. The principal investigator is Wendy G. Lichtenthal, PhD at University of Miami. The trial plans to enroll 415 participants.