Clinical trial NCT05142605: Evaluation of Grief Therapy Approaches for Bereaved Parents
Official title: Meaning-Centered Grief Therapy for Parents Bereaved by Cancer: A Multisite Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Grief
Bereavement
Cancer
Keywords: Parental bereavement
Parents
Elevated prolonged grief symptoms
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-12-02
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Prolonged Grief Disorder-13-R (PG-13-R) scores
timeFrame: Baseline up to 10 months
measure: Change in Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) score
timeFrame: Baseline up to 10 months
Secondary outcomes:
measure: Change in PROMIS: Global Health Scale (PROMIS-GH) scores
timeFrame: Baseline up to 10 months
measure: Change in State-Trait Anxiety Inventory - Short Form (STAI-SF) scores
timeFrame: Baseline up to 10 months
measure: Change in Beck Hopelessness Scale - Short Form (BHS-SF) scores
timeFrame: Baseline up to 10 months
measure: Change in Presence of Regret Scale scores
timeFrame: Baseline up to 10 months
measure: Change in Posttraumatic Growth Inventory - Short Form (PTGI-SF) scores
timeFrame: Baseline up to 10 months
measure: Change in Continuing Bonds Scale (CBS) scores
timeFrame: Baseline up to 10 months
measure: Change in Prolonged Grief Disorder - Clinical Global Impressions Scale - Severity and Improvement Items (PGD-CGI) ratings
timeFrame: Baseline up to 10 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia (Data Collection Only)
state: Pennsylvania
city: Memphis
country: United States
facility: St Jude's Children's Hospital (Data collection only)
state: Tennessee
Study officials:
affiliation: University of Miami
name: Wendy G. Lichtenthal, PhD
role: PRINCIPAL_INVESTIGATOR
References: