Evaluation of Grief Therapy Approaches for Bereaved Parents

University of Miami

Status: Enrolling

Conditions: Grief; Bereavement; Cancer

Treatments: Behavioral: Supportive Psychotherapy; Behavioral: Enhanced Usual Care; Behavioral: Meaning-Centered Grief Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05142605

R01NR019637 (U.S. NIH Grant/Contract)

20230899

Details and patient eligibility

About

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.

Enrollment: 415 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

• 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 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 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)

• 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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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415 participants in 3 patient groups

Cohort 1: Meaning-Centered Grief Therapy (MCGT)

Experimental group

Description:

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

Treatment:

Behavioral: Meaning-Centered Grief Therapy

Group 2: Supportive Psychotherapy (SP)

Active Comparator group

Description:

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

Treatment:

Behavioral: Supportive Psychotherapy

Group 3: Enhanced usual care (EUC)

Active Comparator group

Description:

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

Treatment:

Behavioral: Enhanced Usual Care