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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
415
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.
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.
University of Miami
Miami, Florida, United States
NOT_YET_RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGChildren's Hospital of Philadelphia (Data Collection Only)
Philadelphia, Pennsylvania, United States
RECRUITINGChange 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.
Time frame: 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.
Time frame: Baseline up to 10 months
Change in PROMIS: Global Health Scale (PROMIS-GH) scores
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). The composite score is a sum of each item, and scores range from 10 to 50.
Time frame: Baseline up to 10 months
Change in State-Trait Anxiety Inventory - Short Form (STAI-SF) scores
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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.
St Jude's Children's Hospital (Data collection only)
Memphis, Tennessee, United States
RECRUITINGThe 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.
Time frame: Baseline up to 10 months
Change in Beck Hopelessness Scale - Short Form (BHS-SF) scores
The Beck Hopelessness Scale-Short Form (BHS-SF) is a 4-item true-false self-report measure of participants' degree of pessimism and hopelessness. Scores range from 0 to 12. A higher score indicates more experiences of pessimism or lack of hope.
Time frame: Baseline up to 10 months
Change in Presence of Regret Scale scores
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.
Time frame: Baseline up to 10 months
Change in Posttraumatic Growth Inventory - Short Form (PTGI-SF) scores
The Posttraumatic Growth Inventory-Short Form (PTGI-SF) is a 10-item self-report measure that assesses positive outcomes following stressful life events. Scores range from 0 to 50, and higher total scores reflect higher levels of posttraumatic growth.
Time frame: Baseline up to 10 months
Change in Continuing Bonds Scale (CBS) scores
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. Scores range from 11 to 55, with higher scores reflecting a stronger continued bond.
Time frame: Baseline up to 10 months
Change in Prolonged Grief Disorder - Clinical Global Impressions Scale - Severity and Improvement Items (PGD-CGI) ratings
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. Scores range from 1 to 7, with lower scores indicating low severity of symptoms and improvement in functioning.
Time frame: Baseline up to 10 months