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NCT07318090

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

Enrolling by Invitation
NAAges 8+InterventionalTreatment
University of Pittsburgh
~30 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:F-PGT

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total Score on Feasibility of Intervention Measure (FIM) at End of Treatment
Measured over End of treatment at 20 weeks
+4 more outcomes measured

Conditions

Prolonged Grief Disorder (PGD)

Explore related trials

Prolonged Grief Disorder

Where it's being run

2 sites across 2 states
New York1
Pennsylvania1

Study leadership

  • Nadine A Melhem, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
  • M. Katherine Shear, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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)

What this trial measures

  • Total Score on Feasibility of Intervention Measure (FIM) at End of TreatmentEnd of treatment at 20 weeks

    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.

  • Total Score on Acceptability of Intervention Measure (AIM) at End of TreatmentEnd of treatment at 20 weeks

    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.

  • Change in Inventory of Complicated Grief (ICG) Total ScoreBaseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment

    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.

  • Change in Inventory for Complicated Grief-Revised for Children (ICG-RC) Total ScoreBaseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment

    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.

  • Change in Clinical Global Impression (CGI-S and CGI-I) ScoresBaseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment

    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.