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

University of Pittsburgh

Status

Invitation-only

Conditions

Prolonged Grief Disorder (PGD)

Treatments

Behavioral: F-PGT

Study type

Interventional

Funder types

Other

Identifiers

NCT07318090

LSRG-0-080-22 (Other Grant/Funding Number)

STUDY23070021 (Aim 3)

Details and patient eligibility

About

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.

Full description

Interested potential adult participants will first complete a preliminary screening conducted by phone or secure zoom. Eligible and interested families will meet with a study clinician to provide written informed consent and child assent to participate in a 2-step study process. Step 1 is baseline assessment and confirming study eligibility, and step 2 is Prolonged Grief Treatment for Families (F-PGT).

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.

Enrollment

30 estimated patients

Sex

All

Ages

8+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

Youth exclusion criteria:

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 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.

Parent/Caregiver Exclusion criteria:

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)