Grief Counseling for Bereaved Parents

Overseen By Talia Zaider, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Significant psychiatric disturbance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 32

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Many parents who have lost a child use counseling or other resources to help with the emotional burden of their loss. The aim of this study is to begin to test a new counseling program for parents who have lost a child.

Who Is on the Research Team?

Talia Zaider, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for parents in certain areas of New York, New Jersey, Connecticut, or Pennsylvania who have lost a child and are struggling with grief. They must be at least 18 years old, speak English well enough to complete study tasks, and have been grieving for at least six months.

Inclusion Criteria

Score of 34 or greater (≥ 34) on the PG-13 at screening (N/A for training case participants)

Residing in New York, New Jersey, Connecticut, or Pennsylvania for P1S1; Residing in New York for P1S2; residing in New York or New Jersey or able to complete sessions while complying with current telehealth regulations.

I am the child's biological, adoptive, or stepparent.

Exclusion Criteria

Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or informed consent

Inability to access a computer with Internet or inability to use a computer with Internet provided by the study as indicated by self-report

Another parent or primary caregiver of the child has been enrolled in the study (N/A for training case participants)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Open Trial

Participants receive Meaning-Centered Grief Therapy (MCGT) in two steps to refine the intervention. Step 1 involves in-person sessions, and Step 2 involves videoconferencing.

16 weeks

16 sessions (weekly, 1-hour each)

Part 2: Pilot RCT

Participants are randomized to receive either MCGT or Supportive Psychotherapy (SP) via videoconferencing to assess feasibility, acceptability, and preliminary effects.

16 weeks

16 sessions (weekly, 60-90 minutes each)

Follow-up

Participants are monitored for psychosocial outcomes and acceptability of the intervention at 3 months post-intervention.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Meaning-Centered Grief Therapy (MCGT)
• questionnaires assessments
• Supportive Psychotherapy (SP)

Trial Overview The study tests a new counseling program called Meaning-Centered Grief Therapy (MCGT) against Supportive Psychotherapy (SP). Parents will also fill out questionnaires to help researchers understand the impact of these therapies on their grief.

How Is the Trial Designed?

Group I: Meaning-Centered Grief Therapy (MCGT) Experimental Treatment 2 Interventions

Part 1: Open Trials. Participants (n = 5 for Step 1 \& n = 5 for Step 2) will receive 16 1-hour (approx) weekly sessions MCGT, \& all therapy sessions will be audio recorded. Will make every effort to complete 16 sessions in 16 weeks, due to normal life activities, this is considered an approximation (i.e. there may be weeks where sessions don't take place \&/or weeks where more than 1 session takes place in a week). If participant provides us with permission, we will also video record the sessions. Assessments will be administered at 4 time points: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), \& at 3-months post-intervention (T4). They will provide their feedback about MCGT \& the measures. PI will review the open trial sessions to help refine the MCGT manual \& treatment integrity forms. Sessions for Step 1 participants in Part 1 will be held at the MSK Counseling Center. Sessions for Step 2 participants in Part 1 will be conducted via videoconferencing.

Group II: MCGT or Supportive Psychotherapy Experimental Treatment 3 Interventions

Part 2: Pilot RCT. Will randomize 66 parents to 16 weekly 60-90 minute (approx) sessions of MCGT or SP delivered via videoconferencing. Again, sessions will be audio recorded. If the participant provides us with permission, we also audio/video record the sessions. We will examine aspects of study implementation \& therapy process, including a) recruitment progress, b) implementation of the intervention, c) administration of the assessments, \& d) retention. We will also examine acceptability, defined as measures of satisfaction at T3. Psychosocial outcomes will be assessed with self-report measures at 4 time points: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), \& at 3-months post-intervention (T4). Post-intervention qualitative exit interviews will assess acceptability of the intervention. Post-intervention qualitative exit interviews will assess acceptability of the MCGT intervention .

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Monash University

Collaborator

Trials

204

Recruited

10,570,000+

University of Memphis

Collaborator

Trials

73

Recruited

12,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

University of Hawaii

Collaborator

Trials

122

Recruited

55,200+

Adelphi University

Collaborator

Trials

6

Recruited

5,900+

The New School for Social Research

Collaborator

Trials

9

Recruited

3,200+