Evaluation of Grief Therapy Approaches for Bereaved Parents

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Meaning-Centered Grief Therapy

    Behavioral

    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

    Behavioral

    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.

  • Enhanced Usual Care

    Behavioral

    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.

Treatment groups

415 Participants
are divided into 3 treatment groups
Group A: Cohort 1: Meaning-Centered Grief Therapy (MCGT)Experimental treatment 1 intervention
Group B: Group 2: Supportive Psychotherapy (SP)Active comparator 1 intervention
Group C: Group 3: Enhanced usual care (EUC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change 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
2

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

Secondary outcomes

1

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
2

Change in State-Trait Anxiety Inventory - Short Form (STAI-SF) scores

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.

Time frame
Baseline up to 10 months
3

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
4

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

Other outcomes

Sponsors and contacts

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University of Miami

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator