Evaluation of Grief Therapy Approaches for Bereaved Parents

Study Overview
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Brief Summary
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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.

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

Conditions
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Grief, Bereavement, Intervention, Cancer

Intervention / Treatment
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* Behavioral: Meaning-Centered Grief Therapy
* Behavioral: Supportive Psychotherapy
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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 15 OR lost a child to a cause other than cancer 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 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 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Meaning-Centered Grief Therapy/MCGT<br>Participants will consist of parents who have lost a child to a cancer diagnosis within the last 6 months | Behavioral: Meaning-Centered Grief Therapy<br>* Meaning-centered grief therapy is a therapy that focuses on helping participants find a sense of meaning or purpose in their life after their 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.<br>* Other names: MCGT;|
| Active Comparator: Group 2: Supportive Psychotherapy /SP<br>Participants will consist of parents who have lost a child to a cancer diagnosis within the last 6 months | Behavioral: Supportive Psychotherapy<br>* Supportive psychotherapy will help participants cope with their loss by giving them a place to express their feelings and providing them 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.<br>* Other names: SP;|
| Active Comparator: Group 3: Enhanced usual care/EUC<br>Participants will consist of parents who have lost a child to a cancer diagnosis within the last 6 months | Behavioral: Enhanced Usual Care<br>* Enhanced usual care includes any support or resources participants may receive as part of their standard care (for example, therapy sessions with a local therapist), enhanced with additional resources.<br>* Other names: EUC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged Grief Disorder-13-R (PG-13-R) | 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. | 10 months | 
| Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) | 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. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS: Global Health Scale (PROMIS-GH) | 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). | 10 months | 
| State-Trait Anxiety Inventory - Short Form (STAI-SF) | 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. | 10 months | 
| Beck Hopelessness Scale - Short Form (BHS-SF) | The Beck Hopelessness Scale-Short Form (BHS-SF) is a 4-item true-false self-report measure of participants' degree of pessimism and hopelessness. A higher score indicates more experiences of pessimism or lack of hope. | 10 months | 
| Presence of Regret Scale | 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. | 10 months | 
| Posttraumatic Growth Inventory - Short Form (PTGI-SF) | The Posttraumatic Growth Inventory-Short Form (PTGI-SF) is a 10-item self-report measure that assesses positive outcomes following stressful life events. Scores on these subscales as well as a total score reflect higher levels of posttraumatic growth. | 10 months | 
| Continuing Bonds Scale (CBS) | 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, with higher scores reflecting a stronger continued bond. | 10 months | 
| Prolonged Grief Disorder - Clinical Global Impressions Scale - Severity and Improvement Items (PGD-CGI) | 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 with lower scores indicating low severity of symptoms and improvement in functioning. | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parental bereavement, parents, Elevated prolonged grief symptoms, Memorial Sloan Kettering Cancer Center, 21-462