F-PGT - Prolonged Grief Treatment for Families Affected by Suicide
NCT ID: NCT07318090
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2025-12-17
2026-12-31
Brief Summary
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Detailed Description
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Families who give consent will complete assessments to confirm eligibility for the study. Those who are not eligible will conclude their study participation. Eligible families will complete the remaining baseline assessments and proceed to step 2, treatment.
F-PGT includes 16 virtual sessions where a therapist will meet with either the parent or child, or both. All sessions will be recorded to continue optimize the therapy.
In addition, participants will complete regular assessments.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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F-PGT
Eligible families will receive 16 online sessions of Family-Prolonged Grief Treatment (F-PGT).
F-PGT
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.
Interventions
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F-PGT
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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 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 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)
8 Years
ALL
No
Sponsors
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American Foundation for Suicide Prevention
OTHER
Columbia University
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Nadine Melhem
Professor
Principal Investigators
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Nadine A Melhem, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
M. Katherine Shear, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University
New York, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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LSRG-0-080-22
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY23070021 (Aim 3)
Identifier Type: -
Identifier Source: org_study_id
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