Evaluation of Grief Therapy Approaches for Bereaved Parents
Trial Status: active
This phase II trial compares three types of support programs for parents who have lost a child to see how these programs affect participants’ grief and depression symptoms. The three support programs are called meaning-centered grief therapy, supportive counseling, and enhanced usual care. Meaning-centered grief therapy may improve several mental and physical health outcomes in parents bereaved by cancer, the leading cause of death by disease in children. This trial may help doctors learn more about a counseling program for parents who are coping with the loss of a child.
Inclusion Criteria
- PARTICIPANTS: 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
- PARTICIPANTS: Age 18 or older as indicated by self-report
- PARTICIPANTS: Experienced the loss of a child diagnosed with cancer at least 6 months prior to enrollment by self-report
- PARTICIPANTS: Elevated prolonged grief (PG) symptoms (PG-13-R scores of 30 or above) (not applicable [N/A] for training case participants)
- PARTICIPANTS: 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
- PARTICIPANTS: English-speaking as per the language assessment items below and willing to receive the intervention in English * What is the participant’s preferred language? * 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)
- PARTICIPANTS: Individuals who are pregnant per self-report are eligible to participate
- SUPPORT PROVIDERS: Must be age 18 or over as indicated by self-report
- SUPPORT PROVIDERS: Has been identified by the bereaved parent participant as a support or someone important to bereaved parent
- SUPPORT PROVIDERS: 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
- SUPPORT PROVIDERS: 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)
- FAMILY PARTICIPANTS: 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
- FAMILY PARTICIPANTS: Age 18 or older as indicated by self-report
- FAMILY PARTICIPANTS: Experienced the loss of a child diagnosed with cancer at least 6 months prior to enrollment by self-report
- FAMILY PARTICIPANTS: 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
- FAMILY PARTICIPANTS: 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)
- TRAINING CASE: A biological, adoptive, step-parent, or legal guardian from across the United States as indicated by self-report
- TRAINING CASE: Age 18 or older as indicated by self-report
- TRAINING CASE: Experienced the loss of a child at least 6 months prior to enrollment by self-report
- TRAINING CASE: Score of 29 or below on the PG-13-R 15 OR lost a child to a cause other than cancer
- 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
- TRAINING CASE: English-speaking as per the language assessment items below and willing to receive the intervention in English * What is the participant’s preferred language? * 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)
- TRAINING CASE SUPPORT PROVIDER: Must be age 18 or over as indicated by self-report
- TRAINING CASE SUPPORT PROVIDER: Has been identified by the bereaved parent training case participant as a support or someone important to bereaved parent
- TRAINING CASE SUPPORT PROVIDER: 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
- TRAINING CASE SUPPORT PROVIDER: English-speaking as per the language assessment items below and willing to receive the intervention in English * What is the participant’s preferred language? * 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)
Exclusion Criteria
- PARTICIPANTS: Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent
- PARTICIPANTS: Inability to access a functional device for videoconferencing and declines offer to use a study loaner device as indicated by self-report
- SUPPORT PROVIDERS: Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude informed consent
- SUPPORT PROVIDERS: Inability to access a computer with Internet as indicated by self-report
- FAMILY PARTICIPANTS: Significant psychiatric disturbance sufficient, in the investigator/study staff’s judgment, to preclude informed consent
- FAMILY PARTICIPANTS: Inability to access a computer with Internet as indicated by self-report
- TRAINING CASE: Significant psychiatric disturbance sufficient, in the investigator/study staff’s judgment, to preclude completion of the assessment measures, interview or informed consent
- TRAINING CASE: Inability to access a functional device for videoconferencing and declines offer to use a study loaner device as indicated by self-report
- TRAINING CASE SUPPORT PROVIDER: Significant psychiatric disturbance sufficient, in the investigator/study staff’s judgment, to preclude completion of the assessment measures, interview or informed consent
- TRAINING CASE SUPPORT PROVIDER: Inability to access a computer with Internet as indicated by self-report
Additional locations may be listed on ClinicalTrials.gov for NCT05142605.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Contact: Justin Nathaniel Baker
Phone: 650-725-4187
Email: jusbaker@stanford.edu
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Wendy G. Lichtenthal
Phone: 215-620-3220
Email: wgl31@med.miami.edu
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Talia Zaider
Phone: 646-888-0031
Email: zaidert@mskcc.org
Pennsylvania
Philadelphia
Tennessee
Memphis
Saint Jude Children's Research Hospital
Status: Active
Contact: Justin Nathaniel Baker
Email: justin.baker@stjude.org
PRIMARY OBJECTIVES:
I. Compare the efficacy of meaning-centered grief therapy (MCGT), supportive psychotherapy (SP), and enhanced usual care (EUC) in reducing prolonged grief (PG) and depression symptoms in parents bereaved by cancer.
II. Complement quantitative self-report findings with qualitative data to contextualize the relative efficacy of MCGT and SP.
EXPLORATORY OBJECTIVE:
I. Determine mediators and moderators of outcomes of the intervention arms.
OUTLINE: Parents are randomized to 1 of 3 cohorts.
COHORT I: Parents participate in MCGT support program via videoconference over 60-90 minutes once a week (QW) for 16 sessions.
COHORT II: Parents participate in SP support program via videoconference over 60-90 minutes QW for 16 sessions.
COHORT III: Parents receive EUC per standard of care.
After study completion study, patients are followed up at 3 and 6 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorWendy G. Lichtenthal
- Primary ID20230899
- Secondary IDsNCI-2022-00036, 21-462
- ClinicalTrials.gov IDNCT05142605