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

N/AEnrolling By InvitationNCT07318090

University of Pittsburgh30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prolonged Grief Disorder (PGD)

Interventions

F-PGTBEHAVIORAL

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

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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)

Locations (2)

Columbia University

New York, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

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

Total scores from the Children's Global Assessment Scale (C-GAS) will be used to assess overall child functioning. Total Score C-GAS: 91-100 Superior functioning; 71-90 Good functioning; 51-70 Moderate impairment; 31-50 Serious impairment; 1-30 Severe impairment.

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

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

Total scores from the Global Assessment Scale (GAS) will be used to assess overall parental functioning. Higher scores indicate better functioning.

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

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

Total scores from the Work and Social Adjustment Scale (WSAS) will be used to assess functional impairment. Total Score WSAS: 0-9 Low impairment; 10-20 Significant impairment; \>20 Moderately severe to severe impairment.

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

Change in Parental Reflective Functioning Questionnaire (PRFQ) Total Score

Total scores from the Parental Reflective Functioning Questionnaire (PRFQ) will be used to assess parents' capacity to reflect on their child's mental states. Higher scores indicate greater reflective functioning, except for the Pre-mentalizing subscale where higher scores indicate less adaptive functioning.

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

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

Total scores from the Coping with Children's Negative Emotions Scale (CCNES) will be used to assess parental responses to children's negative emotions. Higher supportive response scores reflect more adaptive parenting.

Time frame: Baseline; 20 weeks assessment

Change in Child and Adolescent Reflective Functioning Scale (CARFS) Score

Data from ClinicalTrials.gov

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Total scores from the Child and Adolescent Reflective Functioning Scale (CARFS) will be used to assess children's ability to understand their own and others' mental states. Higher scores indicate greater reflective functioning.

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

Change in Child-Parent Relationship Scale (CPRS) Total Score

Total scores from the Child-Parent Relationship Scale (CPRS) will be used to assess parent-child relationship quality. Higher scores indicate more positive relationship quality or greater stress on stress-related subscales.

Time frame: Baseline; 4 weeks; 12 weeks; 20 weeks assessment

Presence of Psychiatric Diagnoses as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)

Diagnostic outcomes from the Structured Clinical Interview for DSM-5 (SCID-5) will be used to assess the presence of DSM-5 psychiatric disorders in adults for inclusion/exclusion criteria and will help in assessing global functioning. Each disorder will be coded as 0 (not present), 1 (subthreshold), or 2 (present).

Time frame: Baseline

Change in Psychiatric Diagnoses as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)

Diagnostic outcomes from the Structured Clinical Interview for DSM-5 (SCID-5) will be used to assess changes in DSM-5 psychiatric disorders in adults and in global functioning. Each disorder will be coded as 0 (not present), 1 (subthreshold), or 2 (present).

Time frame: End of treatment at 20 weeks

Presence of Psychiatric Diagnoses as Assessed by K-SADS-PL (Child and Parent Versions)

Diagnostic outcomes from the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL) will be used to assess DSM psychiatric disorders in children and adolescents for inclusion/exclusion criteria and will help in assessing global functioning. Each disorder will be coded as 1 (not present), 2 (subthreshold), or 3 (present).

Time frame: Baseline; 20 weeks assessment

Change in DSM Psychiatric Diagnoses as Assessed by Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)

Diagnostic outcomes from the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL) will be used to assess changes in DSM psychiatric disorders in children and adolescents and in global functioning. Each disorder will be coded as 1 (not present), 2 (subthreshold), or 3 (present).

Time frame: End of treatment at 20 weeks

Total Score on Prolonged Grief Disorder-13 (PG-13) Scale

Total scores from the Prolonged Grief Disorder-13 (PG-13) scale will be used to assess severity of prolonged grief symptoms. Total Score PG-13: 10-29 Mild grief; 30-50 Clinically significant prolonged grief.

Time frame: Baseline

Change in Total Score on Prolonged Grief Disorder-13 (PG-13) Scale

Time frame: 20 weeks assessment

Observed Parent-Child Communication Behaviors During Virtual Interaction Tasks

Observed parent-child communication behaviors will be assessed during three 5-minute structured virtual interaction tasks (discussion of friendships, resolution of a minor conflict, and planning a "dream vacation"). Video-recorded sessions will be coded by trained raters using a standardized observational coding system. Higher scores indicate more adaptive communication behaviors.

Time frame: Baseline

Change in Observed Parent-Child Communication Behaviors During Virtual Interaction Tasks

Change in observed parent-child communication behaviors will be assessed during three 5-minute structured virtual interaction tasks. Video-recorded sessions will be coded by trained raters using a standardized observational coding system. Positive change scores indicate improvement in communication behaviors from baseline.

Time frame: End of treatment at 20 weeks

Observed Parent-Child Attachment Behaviors During Virtual Interaction Tasks

Observed attachment-related behaviors between parent and child will be assessed during three 5-minute structured virtual interaction tasks. Video-recorded sessions will be coded by trained raters using a standardized observational coding system. Higher scores indicate more secure attachment behaviors.

Time frame: Baseline

Change in Observed Parent-Child Attachment Behaviors During Virtual Interaction Tasks

Change in observed parent-child attachment behaviors will be assessed during three 5-minute structured virtual interaction tasks. Video-recorded sessions will be coded by trained raters using a standardized observational coding system. Positive change scores indicate improvement in attachment behaviors from baseline.

Time frame: End of treatment at 20 weeks

Observed Parent and Child Reflective Functioning During Virtual Interaction Tasks

Observed reflective functioning of parents and children will be assessed during three 5-minute structured virtual interaction tasks. Video-recorded sessions will be coded by trained staff using a validated reflective functioning coding framework. Higher scores indicate greater capacity to recognize and interpret mental states.

Time frame: Baseline

Change in Observed Parent and Child Reflective Functioning During Virtual Interaction Tasks

Change in observed reflective functioning of parents and children will be assessed during three 5-minute structured virtual interaction tasks. Video-recorded sessions will be coded by trained staff using a validated reflective functioning coding framework. Positive change scores indicate improvement in reflective functioning from baseline.

Time frame: End of treatment at 20 weeks