Evaluation of Grief Therapy Approaches for Bereaved Parents

June 29, 2026 updated by: Wendy G. Lichtenthal, University of Miami

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
415

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University (Data Collection Only)
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami
        • Principal Investigator:
          • Wendy Lichtenthal, PhD
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Talia Zaider, PhD
        • Contact:
          • Talia Zaider, PhD
          • Phone Number: 646-888-0162
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia (Data Collection Only)
        • Principal Investigator:
          • Lamia Barakat, PhD
        • Contact:
          • Lamia Barakat, PhD
          • Phone Number: (267) 426-0762
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St Jude's Children's Hospital (Data collection only)
        • Contact:
        • Principal Investigator:
          • Erica Kaye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1: Meaning-Centered Grief Therapy (MCGT)
Participants will receive the MCGT intervention for approximately 4 months or longer as needed.
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.
Other Names:
  • MCGT
Active Comparator: Group 2: Supportive Psychotherapy (SP)
Participants will receive the SP intervention for approximately 4 months or longer as needed.
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.
Other Names:
  • SP
Active Comparator: Group 3: Enhanced usual care (EUC)
Participants will receive EUC for approximately 4 months or longer as needed.
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.
Other Names:
  • EUC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Prolonged Grief Disorder-13-R (PG-13-R) scores
Time Frame: Baseline up to 10 months
The Prolonged Grief-13-Revised (PG-13-R) is a 13-item self-report scale evaluating the proposed symptoms of prolonged grief disorder. The PG-13-R assesses the severity of 10 grief-related symptoms using a 5-point Likert-type scale. Additional items evaluate the experience of a significant loss, symptom duration, and functional impairment. The PG-13-R yields a score between 10 and 50, where a higher score indicates that a person experiences higher levels of prolonged grief.
Baseline up to 10 months
Change in Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) score
Time Frame: Baseline up to 10 months
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) is a 20-item self-report measure assessing the frequency of depressive symptoms in the past week on a 4-point scale. Total scores range from 0 to 60, with scores above 16 indicating possible clinically significant depression levels.
Baseline up to 10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in PROMIS: Global Health Scale (PROMIS-GH) scores
Time Frame: Baseline up to 10 months
The PROMIS-Global Health Scale (PROMIS-GH), is a National Institutes of Health-developed and well-validated self-report assessment that captures global mental health (i.e., quality of life, mental health, satisfaction with social activities, and emotional problems) and physical health (i.e., physical health, physical function, pain, and fatigue). PROMIS-GH consists of 10-items, with each utilizing a 7-day recall period. The initial 9-items make use of a 5-point scale, with 3 separate verbal anchors that ask patients to rate their health or abilities, indicate how often they are experiencing a phenomenon or how severe their symptomatic experience is. A final item asks patients to indicate their average pain on a 0-10 numeric rating scale (i.e., 0 = no pain, 10 = worst pain imaginable). The composite score is a sum of each item, and scores range from 10 to 50.
Baseline up to 10 months
Change in State-Trait Anxiety Inventory - Short Form (STAI-SF) scores
Time Frame: Baseline up to 10 months
The State-Trait Anxiety Inventory (STAI-SF) is a 10-item valid and reliable self-report measure of both state and trait anxiety. For both of these subscales, higher scores indicate higher levels of anxiety. Responses range from 1 (almost never) to 4 (almost always), with higher scores reflecting increased anxiety.
Baseline up to 10 months
Change in Beck Hopelessness Scale - Short Form (BHS-SF) scores
Time Frame: Baseline up to 10 months
The Beck Hopelessness Scale-Short Form (BHS-SF) is a 4-item true-false self-report measure of participants' degree of pessimism and hopelessness. Scores range from 0 to 12. A higher score indicates more experiences of pessimism or lack of hope.
Baseline up to 10 months
Change in Presence of Regret Scale scores
Time Frame: Baseline up to 10 months
The presence of regret and associated distress will be assessed by items used in the investigative team's prior research on regret. The measure asks respondents to rate level of distress associated with regret on a scale from 1-10 with higher scores indicating greater distress.
Baseline up to 10 months
Change in Posttraumatic Growth Inventory - Short Form (PTGI-SF) scores
Time Frame: Baseline up to 10 months
The Posttraumatic Growth Inventory-Short Form (PTGI-SF) is a 10-item self-report measure that assesses positive outcomes following stressful life events. Scores range from 0 to 50, and higher total scores reflect higher levels of posttraumatic growth.
Baseline up to 10 months
Change in Continuing Bonds Scale (CBS) scores
Time Frame: Baseline up to 10 months
The Continuing Bonds Scale (CBS) is an 11-item self-report measure that assesses the degree of continued connection with a deceased loved one on a 5-point scale. Scores range from 11 to 55, with higher scores reflecting a stronger continued bond.
Baseline up to 10 months
Change in Prolonged Grief Disorder - Clinical Global Impressions Scale - Severity and Improvement Items (PGD-CGI) ratings
Time Frame: Baseline up to 10 months
The Prolonged Grief Disorder-Clinical Global Impression Scale (PGD-CGI), adapted from trials examining Complicated Grief Treatment, will be used to assess global severity and symptom improvement. It is a two-item observer assessment that uses a seven-point scale for a global rating of illness severity and improvement. Scores range from 1 to 7, with lower scores indicating low severity of symptoms and improvement in functioning.
Baseline up to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wendy G. Lichtenthal, PhD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230899
  • R01NR019637 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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