Recruiting

Meaning-Centered Grief Therapy, Supportive Counseling, Enhanced Usual Care

Sponsor:

University of Miami

Code:

NCT05142605

Conditions

Grief

Bereavement

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Meaning-Centered Grief Therapy

Supportive Psychotherapy

Enhanced Usual Care

Study Details

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.

Conditions

Grief

Bereavement

Cancer

Study ID

NCT05142605

Start date

Mar 31, 2022

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

415 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Meaning-Centered Grief Therapy (MCGT)

Participants will receive the MCGT intervention for approximately 4 months or longer as needed.

active comparator: Group 2: Supportive Psychotherapy (SP)

Participants will receive the SP intervention for approximately 4 months or longer as needed.

active comparator: Group 3: Enhanced usual care (EUC)

Participants will receive EUC for approximately 4 months or longer as needed.

Interventions

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.

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.

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.

Primary outcome measure

  • Change in Prolonged Grief Disorder-13-R (PG-13-R) scores [ Time Frame: Baseline up to 10 months ]
  • Change in Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) score [ Time Frame: Baseline up to 10 months ]

Central Contacts and Locations

Central contacts

Wendy G. Lichtenthal, PhD

305-243-8983wendy.lichtenthal@miami.edu

Locations

Stanford University (Data Collection Only)

Recruiting

Stanford, California, United States, 94305

Contacts

Justin Baker, MD

650-725-4187jusbaker@stanford.edu

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Talia Zaider, PhD

646-888-0162

Principal Investigator:

Talia Zaider, PhD

Children's Hospital of Philadelphia (Data Collection Only)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Lamia Barakat, PhD

(267) 426-0762

Principal Investigator:

Lamia Barakat, PhD

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

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Erica Kaye, MD

901-595-8188erica.kaye@stjude.org

Principal Investigator:

Erica Kaye

More Information

Sponsor

University of Miami

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Parental bereavement
  • Parents
  • Elevated prolonged grief symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Miami on 2026-07-01.