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RECRUITING

NCT05142605

Evaluation of Grief Therapy Approaches for Bereaved Parents

Sponsor: University of Miami

View on ClinicalTrials.gov

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.

Official title: Meaning-Centered Grief Therapy for Parents Bereaved by Cancer: A Multisite Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

415

Start Date

2022-03-31

Completion Date

2026-05-31

Last Updated

2026-03-24

Healthy Volunteers

Conditions

Grief Bereavement Cancer

Interventions

BEHAVIORAL

Meaning-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.

BEHAVIORAL

Supportive 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.

BEHAVIORAL

Enhanced 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.

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

Locations (5)

Stanford University (Data Collection Only)

Stanford, California, United States

University of Miami

Miami, Florida, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Children's Hospital of Philadelphia (Data Collection Only)

Philadelphia, Pennsylvania, United States

St Jude's Children's Hospital (Data collection only)

Memphis, Tennessee, United States

Clinical Research Directory

Evaluation of Grief Therapy Approaches for Bereaved Parents

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (5)