F-PGT - Prolonged Grief Treatment for Families Affected by Suicide

NCT07318090 | Enrolling By Invitation

• 2 other identifiers: STUDY23070021 (Aim 3)LSRG-0-080-22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot open trial is being done to better understand the needs of families who have lost a parent to suicide at least a year ago and who have children ages 8-14 and to develop and test Family-Prolonged Grief Treatment (F-PGT), a modification of prolonged grief therapy (PGT) as a way to help these families. PGT has been proven efficacious for adults with prolonged grief. The therapy has been adapted to include work with parents in helping their children (aged 8-14) and to include sessions with the child. All assessment and treatment sessions of the study are being conducted virtually.

Conditions

Prolonged Grief Disorder (PGD)

Keywords

Prolonged Grief Disorder; Suicide loss survivor; Family treatment; Prolonged Grief Treatment; Grief

Outcome Measures

Primary Outcomes (5)

• Total Score on Feasibility of Intervention Measure (FIM) at End of Treatment

  Total scores from the Feasibility of Intervention Measure (FIM) will be used to assess participants' perception of intervention feasibility. Total Score FIM: 4-8 Low feasibility; 9-15 Moderate feasibility; 16-20 High feasibility.

  End of treatment at 20 weeks

• Total Score on Acceptability of Intervention Measure (AIM) at End of Treatment

  Total scores from the Acceptability of Intervention Measure (AIM) will be used to assess participants' perception of intervention acceptability. Total Score AIM: 4-8 Low acceptability; 9-15 Moderate acceptability; 16-20 High acceptability.

  End of treatment at 20 weeks

• Change in Inventory of Complicated Grief (ICG) Total Score

  Total scores from the Inventory of Complicated Grief (ICG) will be used to assess severity of complicated grief symptoms in adults. Total Score ICG: 0-24 Minimal grief; 25-29 Mild/moderate grief; ≥30 Clinically significant grief.

  Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment

• Change in Inventory for Complicated Grief-Revised for Children (ICG-RC) Total Score

  Total scores from the Inventory for Complicated Grief-Revised for Children (ICG-RC) will be used to assess severity of prolonged grief symptoms in children and adolescents. Total Score ICG-RC: 28-67 Minimal/mild grief; ≥68 Clinically significant prolonged grief.

  Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment

• Change in Clinical Global Impression (CGI-S and CGI-I) Scores

  Clinician-rated scores from the Clinical Global Impression scale will be used to assess global severity and improvement. CGI-Severity: 1-2 Normal/mild; 3-4 Moderate; 5-7 Severe. CGI-Improvement: 1-2 Improved; 3-4 No change; 5-7 Worsened.

  Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment

Secondary Outcomes (19)

• Change in Child Global Assessment Scale (C-GAS) Total Score

  Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment

• Change in Global Assessment Scale (GAS) Total Score (Parent)

  Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment

• Change in Work and Social Adjustment Scale (WSAS) Total Score

  Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment

• Change in Parental Reflective Functioning Questionnaire (PRFQ) Total Score

  Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment

• Change in Coping with Children's Negative Emotions Scale (CCNES) Total Score

  Baseline; 20 weeks assessment

Other Outcomes (7)

• Change in Depressive Symptoms as Assessed by Quick Inventory of Depressive Symptomatology (QIDS)

  Baseline; 12 weeks; 20 weeks assessment

• Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder-7 (GAD-7)

  Baseline; 12 weeks; 20 weeks assessment

• Change in Posttraumatic Stress Symptoms as Assessed by Davidson Trauma Scale (DTS)

  Baseline; 12 weeks; 20 weeks assessment

Study Arms (1)

F-PGT

EXPERIMENTAL

Eligible families will receive 16 online sessions of Family-Prolonged Grief Treatment (F-PGT).

Behavioral: F-PGT

Interventions

F-PGT BEHAVIORAL

Family- Prolonged Grief Treatment (F-PGT) is a specialized talk therapy to help families who have lost a parent to suicide. It is based on Prolonged Grief Therapy (PGT) that is efficacious for adults and is now adapted for parents and their children ages 8 to 14. The therapy includes 16 online sessions where a therapist meets with the parent alone, the child alone, or both together. Activities for children are designed to match their age and understanding. The therapy guides families through six steps: understanding and accepting grief, seeing promise in the future, strengthening relationships, sharing the story of the death, living with reminders, and connecting with memories. As a part of the focus on strengthening relationships parents are encouraged to invite a friend or relative to join a session.

F-PGT

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parental suicide bereaved children aged 8-14 years and their parents or caregivers.
• Child score of 68 or higher on the Inventory for Complicated Grief-Revised for Children (ICG-RC) and/or parent score of 5 or higher on the Brief Grief Questionnaire at phone screen and score of 30 or higher on the Inventory for Complicated Grief (ICG) at baseline.
• At least 12 months after death.
• Child and/or parent's primary concern is prolonged grief
• Child has a biological/adoptive parent or court-appointed guardian who can present paperwork that they are able to consent for research for the youth involved in the study. Child is currently living with this caregiver and has spent most of their time in the past year under their care.
• Both child and parent/caregiver have a clinical provider to communicate safety concerns (e.g., primary care provider, pediatrician)
• Both child and parent/caregiver live in the United States
• If taking psychoactive medications, has been on a stable dose for at least 3 months.

You may not qualify if:

• Limited cognitive abilities to assent or to participate in the therapy (e.g., acute mania, psychosis, severe autism spectrum disorder)
• Unstable serious medical condition
• Current residence is in a state in which none of the study therapists are licensed (i.e., Alaska, Hawaii, Iowa, Louisiana, Massachusetts, Montana, New Mexico, Oregon)
• Has a substance use disorder (determined by KSADS during the baseline assessment)
• Is currently in therapy and unwilling to pause it for the study duration, or begins therapy during the period of study participation
• Those with active suicidality (C-SSRS scores of 3 or higher)
• Those who report any suicidal behaviors in the past year (i.e., suicide attempt, interrupted attempt, aborted attempt, preparatory behaviors), including any formal crisis management in the past year (e.g., presented at emergency department for suicidality), as assessed at baseline.
• Age younger than 18 years old
• Limited cognitive abilities to consent (e.g., acute mania, psychosis)
• Unstable serious medical condition
• For those with active suicidality (C-SSRS scores of 3 or higher), eligibility will be determined by the clinical team and PIs based on prior history of suicidality, access to lethal means, availability social support, reasons for living, and engagement in safety planning.
• Those who report any suicidal behaviors in the past year (i.e., suicide attempt, interrupted attempt, aborted attempt, preparatory behaviors), including any formal crisis management in the past year (e.g., presented at emergency department for suicidality), as assessed at baseline.
• Is currently in therapy and unwilling to pause it for the study duration, or begins therapy during the study duration
• Current residence is in a state in which none of the study therapists are licensed (i.e., Alaska, Hawaii, Iowa, Louisiana, Massachusetts, Montana, New Mexico, Oregon)
• Has a substance use disorder (determined by SCID during the baseline assessment)

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Foundation for Suicide Prevention: collaborator
• Columbia University: collaborator

Study Sites (2)

Columbia University

New York, New York, 10032, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (10)

• Melhem NM, Walker M, Moritz G, Brent DA. Antecedents and sequelae of sudden parental death in offspring and surviving caregivers. Arch Pediatr Adolesc Med. 2008 May;162(5):403-10. doi: 10.1001/archpedi.162.5.403.

  PMID: 18458185 BACKGROUND

• Melhem NM, Porta G, Shamseddeen W, Walker Payne M, Brent DA. Grief in children and adolescents bereaved by sudden parental death. Arch Gen Psychiatry. 2011 Sep;68(9):911-9. doi: 10.1001/archgenpsychiatry.2011.101.

  PMID: 21893658 BACKGROUND

• Hamdan S, Mazariegos D, Melhem NM, Porta G, Payne MW, Brent DA. Effect of parental bereavement on health risk behaviors in youth: a 3-year follow-up. Arch Pediatr Adolesc Med. 2012 Mar;166(3):216-23. doi: 10.1001/archpediatrics.2011.682.

  PMID: 22393180 BACKGROUND

• Pham S, Porta G, Biernesser C, Walker Payne M, Iyengar S, Melhem N, Brent DA. The Burden of Bereavement: Early-Onset Depression and Impairment in Youths Bereaved by Sudden Parental Death in a 7-Year Prospective Study. Am J Psychiatry. 2018 Sep 1;175(9):887-896. doi: 10.1176/appi.ajp.2018.17070792. Epub 2018 Jun 20.

  PMID: 29921145 BACKGROUND

• Melhem NM, Porta G, Walker Payne M, Brent DA. Identifying prolonged grief reactions in children: dimensional and diagnostic approaches. J Am Acad Child Adolesc Psychiatry. 2013 Jun;52(6):599-607.e7. doi: 10.1016/j.jaac.2013.02.015. Epub 2013 Apr 24.

  PMID: 23702449 BACKGROUND

• Melhem NM, Moritz G, Walker M, Shear MK, Brent D. Phenomenology and correlates of complicated grief in children and adolescents. J Am Acad Child Adolesc Psychiatry. 2007 Apr;46(4):493-499. doi: 10.1097/chi.0b013e31803062a9.

  PMID: 17420684 BACKGROUND

• Shear K, Frank E, Houck PR, Reynolds CF 3rd. Treatment of complicated grief: a randomized controlled trial. JAMA. 2005 Jun 1;293(21):2601-8. doi: 10.1001/jama.293.21.2601.

  PMID: 15928281 BACKGROUND

• Shear MK, Wang Y, Skritskaya N, Duan N, Mauro C, Ghesquiere A. Treatment of complicated grief in elderly persons: a randomized clinical trial. JAMA Psychiatry. 2014 Nov;71(11):1287-95. doi: 10.1001/jamapsychiatry.2014.1242.

  PMID: 25250737 BACKGROUND

• Shear MK, Reynolds CF 3rd, Simon NM, Zisook S, Wang Y, Mauro C, Duan N, Lebowitz B, Skritskaya N. Optimizing Treatment of Complicated Grief: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):685-94. doi: 10.1001/jamapsychiatry.2016.0892.

  PMID: 27276373 BACKGROUND

• Hamdan S, Melhem NM, Porta G, Song MS, Brent DA. Alcohol and substance abuse in parentally bereaved youth. J Clin Psychiatry. 2013 Aug;74(8):828-33. doi: 10.4088/JCP.13m08391.

  PMID: 24021502 BACKGROUND

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Nadine A Melhem, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• M. Katherine Shear, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Open trial

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: December 17, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)