Evaluation of Grief Therapy Approaches for Bereaved Parents

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: Recruiting
• Conditions: Cancer; Grief; Bereavement
• Intervention / Treatment: Behavioral: Meaning-Centered Grief Therapy; Behavioral: Supportive Psychotherapy; Behavioral: Enhanced Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 415
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendy G. Lichtenthal, PhD; Phone Number: 305-243-8983; Email: wendy.lichtenthal@miami.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University (Data Collection Only)
      • Contact: Justin Baker, MD; Phone Number: 650-725-4187; Email: jusbaker@stanford.edu
  • Florida
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • University of Miami
      • Principal Investigator: Wendy Lichtenthal, PhD
      • Contact: Wendy Lichtenthal; Phone Number: 305-243-8983; Email: wendy.lichtenthal@miami.edu
  • 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: Erica Kaye, MD; Phone Number: 901-595-8188; Email: erica.kaye@stjude.org
      • Principal Investigator: Erica Kaye

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Prolonged Grief Disorder-13-R (PG-13-R) scores	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	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

Outcome Measure	Measure Description	Time Frame
Change in PROMIS: Global Health Scale (PROMIS-GH) scores	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	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	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	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	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	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	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

• Sponsor: University of Miami
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Wendy G. Lichtenthal, PhD, University of Miami

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: November 21, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Parents; Parental bereavement; Elevated prolonged grief symptoms
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID 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