Evaluation of Grief Therapy Approaches for Bereaved Parents

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142605
• Other study ID #: 20230899
• Secondary ID: R01NR019637
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Wendy G. Lichtenthal, PhD
• Phone: 305-243-8983
• Email: wendy.lichtenthal[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 415
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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)

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)

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 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)

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 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
• 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)

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)

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

Related Conditions & MeSH terms

• Bereavement
• Cancer
• Grief

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	St Jude's Children's Hospital (Data collection only)	Memphis	Tennessee
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

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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