Clinical trial · Interventional

Evaluation of Grief Therapy Approaches for Bereaved Parents

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

NCT05142605CI-TRIAL-00116553recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bereavement	—	UNRESOLVED	—
Cancer	Malignant Neoplasm	ALIAS	0.90
Grief	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Enhanced Usual Care	Behavioral	—	UNRESOLVED
Meaning-Centered Grief Therapy	Behavioral	—	UNRESOLVED
Supportive Psychotherapy	Behavioral	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Cohort 1: Meaning-Centered Grief Therapy (MCGT)
description
Participants will receive the MCGT intervention for approximately 4 months or longer as needed.
interventionNames
1. Behavioral: Meaning-Centered Grief Therapy
type
ACTIVE_COMPARATOR
label
Group 2: Supportive Psychotherapy (SP)
description
Participants will receive the SP intervention for approximately 4 months or longer as needed.
interventionNames
1. Behavioral: Supportive Psychotherapy
type
ACTIVE_COMPARATOR
label
Group 3: Enhanced usual care (EUC)
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Mar 31, 2022
Primary completion: May 31, 2027
Completion: May 31, 2027
First posted: Dec 2, 2021
Last update posted: Jul 1, 2026
Enrollment: 415 (estimated)
Lead sponsor: University of Miami OTHER
Collaborators: National Institute of Nursing Research (NINR)
Keywords: Parental bereavement, Parents, Elevated prolonged grief symptoms

Data updated 22 days agoSource updated Jul 1, 2026source: clinicaltrials

Locations

Locations by country (5)

Country	Sites	Recruiting
United States	5	4

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.