NCT05142605NARecruiting
Evaluation of Grief Therapy Approaches for Bereaved Parents
University of Miami
Start Date
3/31/2022
Completion Date
5/31/2027
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
Age Range: 18 years to No maximum
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
Interventions
BEHAVIORAL
Meaning-Centered Grief Therapy
BEHAVIORAL
Supportive Psychotherapy
BEHAVIORAL
Enhanced Usual Care
Conditions
GriefBereavementCancer
Locations
Stanford University (Data Collection Only)
Stanford, California 94305
United States
University of Miami
Miami, Florida 33136
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Children's Hospital of Philadelphia (Data Collection Only)
Philadelphia, Pennsylvania 19104
United States
St Jude's Children's Hospital (Data collection only)
Memphis, Tennessee 38105
United States