Evaluation of Grief Therapy Approaches for Bereaved Parents

NCT05142605 | Recruiting DMC

• 2 other identifiers: 20230899R01NR019637
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 5

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

Keywords

Parental bereavement; Parents; Elevated prolonged grief symptoms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in PROMIS: Global Health Scale (PROMIS-GH) scores

  Baseline up to 10 months

• Change in State-Trait Anxiety Inventory - Short Form (STAI-SF) scores

  Baseline up to 10 months

• Change in Beck Hopelessness Scale - Short Form (BHS-SF) scores

  Baseline up to 10 months

• Change in Presence of Regret Scale scores

  Baseline up to 10 months

• Change in Posttraumatic Growth Inventory - Short Form (PTGI-SF) scores

  Baseline up to 10 months

Study Arms (3)

Cohort 1: Meaning-Centered Grief Therapy (MCGT)

EXPERIMENTAL

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

Behavioral: Meaning-Centered Grief Therapy

Group 2: Supportive Psychotherapy (SP)

ACTIVE COMPARATOR

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

Behavioral: Supportive Psychotherapy

Group 3: Enhanced usual care (EUC)

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care

Interventions

Meaning-Centered Grief Therapy BEHAVIORAL

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.

Also known as: MCGT

Cohort 1: Meaning-Centered Grief Therapy (MCGT)

Supportive Psychotherapy BEHAVIORAL

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.

Also known as: SP

Group 2: Supportive Psychotherapy (SP)

Enhanced Usual Care BEHAVIORAL

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.

Also known as: EUC

Group 3: Enhanced usual care (EUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Must be age 18 or over as indicated by self-report

You may not qualify if:

• 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
• 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
• 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
• 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

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (5)

Stanford University (Data Collection Only)

Stanford, California, 94305, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

NOT YET RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Children's Hospital of Philadelphia (Data Collection Only)

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

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

Memphis, Tennessee, 38105, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Wendy G. Lichtenthal, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy G. Lichtenthal, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pending Rank

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 2, 2021
• Study Start: March 31, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)