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

Official title

Developing a Family-Focused Treatment for Prolonged Grief for Parental Suicide Bereaved Families With Children

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.

Detailed 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.

Interventions

• Behavioral 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

Primary outcome measures

• Total Score on Feasibility of Intervention Measure (FIM) at End of Treatment [Time frame: End of treatment at 20 weeks]
• Total Score on Acceptability of Intervention Measure (AIM) at End of Treatment [Time frame: End of treatment at 20 weeks]
• Change in Inventory of Complicated Grief (ICG) Total Score [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 [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 [Time frame: Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment]

Secondary outcome measures (12)

• Change in Child Global Assessment Scale (C-GAS) Total Score [Time frame: Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment]
• Change in Global Assessment Scale (GAS) Total Score (Parent) [Time frame: Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment]
• Change in Work and Social Adjustment Scale (WSAS) Total Score [Time frame: Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment]
• Change in Parental Reflective Functioning Questionnaire (PRFQ) Total Score [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 [Time frame: Baseline; 20 weeks assessment]
• Change in Child and Adolescent Reflective Functioning Scale (CARFS) Score [Time frame: Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment]
• Change in Child-Parent Relationship Scale (CPRS) Total Score [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) [Time frame: Baseline]
• Change in Psychiatric Diagnoses as Assessed by Structured Clinical Interview for DSM-5 (SCID-5) [Time frame: End of treatment at 20 weeks]
• Presence of Psychiatric Diagnoses as Assessed by K-SADS-PL (Child and Parent Versions) [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) [Time frame: End of treatment at 20 weeks]
• Total Score on Prolonged Grief Disorder-13 (PG-13) Scale [Time frame: Baseline]

Eligibility criteria

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 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.

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 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Columbia University — New York
• University of Pittsburgh — Pittsburgh

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07318090 · STUDY23070021 (Aim 3) · LSRG-0-080-22

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗