Development of Psychotherapeutic Interventions for Parents Who Lost a Child

NCT02153619 | Active Not Recruiting

• 1 other identifier: 14-102
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parents Who Have Lost a Child

Keywords

Grief; bereavement; questionnaires; therapy sessions; 14-102

Outcome Measures

Primary Outcomes (2)

• feasibility defined and measured as the proportion of participants who complete at least 8 out of 16 sessions of therapy as well as completion of the T3 PG-13 assessment

  4 years

• psychological outcome data in prolonged grief symptoms, assessed with the PG-13 summary score.

  4 years

Study Arms (2)

Meaning-Centered Grief Therapy (MCGT)

EXPERIMENTAL

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.

Behavioral: Meaning-Centered Grief Therapy (MCGT); Behavioral: questionnaires assessments

MCGT or Supportive Psychotherapy

EXPERIMENTAL

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 .

Behavioral: Meaning-Centered Grief Therapy (MCGT); Behavioral: Supportive Psychotherapy (SP); Behavioral: questionnaires assessments

Interventions

Meaning-Centered Grief Therapy (MCGT) BEHAVIORAL

MCGT is a manualized, one-on-one intervention that uses psychoeducation, experiential exercises, and homework focusing on themes related to meaning, identity, purpose, and legacy. Post-intervention qualitative exit interviews will assess acceptability of the MCGT intervention (see Appendix I). Participants randomized to MCGT will provide their feedback about MCGT and the measures (n = 33).

MCGT or Supportive Psychotherapy; Meaning-Centered Grief Therapy (MCGT)

Supportive Psychotherapy (SP) BEHAVIORAL

"SP is the comparison condition in this study and is a standardized, manualized intervention developed by the MSK Psychiatry Service and utilized in our completed and ongoing RCTs of Meaning-Centered Psychotherapy."

MCGT or Supportive Psychotherapy

questionnaires assessments BEHAVIORAL

MCGT or Supportive Psychotherapy; Meaning-Centered Grief Therapy (MCGT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Loss of a child at least 6 months
• Biological or adoptive parent or stepparent as reported in the child's medical record or by parent report
• Parent must be age 18 or over as reported by parent
• In the judgment of investigators/consenting professionals, able to comprehend English to complete study assessments
• 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.
• 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
• Must reside in New York or New Jersey or able to complete sessions while complying with current telehealth regulations.

You may not qualify if:

• 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)
• For the Part 2 RCT, participated in Part 1, Step 1 or 2.
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• University of Memphis: collaborator
• University of Hawaii: collaborator
• Adelphi University: collaborator
• Weill Medical College of Cornell University: collaborator
• University of Southern California: collaborator
• The New School for Social Research: collaborator
• Monash University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Talia Zaider, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 3, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-06

Locations

US (1)