Comparing grief therapy approaches for parents who lost a child
Meaning-Centered Grief Therapy for Parents Bereaved by Cancer: A Multisite Randomized Controlled Trial
This study tests which of three different support programs can help parents cope better with the grief of losing a child to cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 415 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 5 sites (Stanford, California and 4 other locations) |
| Trial ID | NCT05142605 on ClinicalTrials.gov |
What this trial studies
This study evaluates three different support programs designed for parents who have experienced the loss of a child due to cancer. The programs being compared are Meaning-Centered Grief Therapy, Supportive Counseling, and Enhanced Usual Care. Participants will be assessed on their grief and depression symptoms to determine the effectiveness of each approach. The study aims to provide insights into which type of support may be most beneficial for bereaved parents.
Who should consider this trial
Good fit: Ideal candidates are biological, adoptive, or step-parents who lost a child to cancer at least six months prior and are experiencing elevated prolonged grief symptoms.
Not a fit: Patients who have not lost a child to cancer or those who do not meet the prolonged grief symptom criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective therapeutic options to help bereaved parents manage their grief and improve their mental health.
How similar studies have performed: Other studies have shown success with grief therapy approaches, indicating potential for positive outcomes in similar interventions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stanford, California and 4 other locations
- Stanford University (Data Collection Only) — Stanford, California, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Not_yet_recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Children's Hospital of Philadelphia (Data Collection Only) — Philadelphia, Pennsylvania, United States (Recruiting)
- St Jude's Children's Hospital (Data collection only) — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Wendy G. Lichtenthal, PhD — University of Miami
- Study coordinator: Wendy G. Lichtenthal, PhD
- Email: wendy.lichtenthal@miami.edu
- Phone: 305-243-8983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.