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| ID | Type | Description | Link |
|---|---|---|---|
| LSRG-0-080-22 | Other Grant/Funding Number | American Foundation for Suicide Prevention (AFSP) |
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| Name | Class |
|---|---|
| American Foundation for Suicide Prevention | OTHER |
| Columbia University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F-PGT | Experimental | Eligible families will receive 16 online sessions of Family-Prolonged Grief Treatment (F-PGT). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-PGT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptoms as Assessed by Quick Inventory of Depressive Symptomatology (QIDS) | Total scores from the Quick Inventory of Depressive Symptomatology (QIDS) will be used to assess depressive symptom severity. Higher scores indicate greater depression severity. | Baseline; 12 weeks; 20 weeks assessment |
Inclusion Criteria:
Exclusion Criteria:
Youth exclusion criteria:
Parent/Caregiver Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadine A Melhem, PhD | University of Pittsburgh | Principal Investigator |
| M. Katherine Shear, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States | ||
| University of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18458185 | Background | 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. | |
| 21893658 | Background | 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. |
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Not required by the funding agency.
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| ID | Term |
|---|---|
| D000090382 | Prolonged Grief Disorder |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Open trial
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| 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. | 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. | 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. | 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. | Baseline; 20 weeks assessment |
| Change in Child and Adolescent Reflective Functioning Scale (CARFS) Score | 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. | 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. | 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). | 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). | 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). | 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). | 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. | Baseline |
| Change in 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. | 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. | 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. | 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. | 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. | 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. | 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. | End of treatment at 20 weeks |
| Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder-7 (GAD-7) |
Total scores from the Generalized Anxiety Disorder-7 (GAD-7) will be used to assess anxiety severity. Higher scores indicate greater anxiety. |
| Baseline; 12 weeks; 20 weeks assessment |
| Change in Posttraumatic Stress Symptoms as Assessed by Davidson Trauma Scale (DTS) | Total scores from the Davidson Trauma Scale (DTS) will be used to assess severity of posttraumatic stress symptoms. Higher scores indicate greater trauma-related distress. | Baseline; 12 weeks; 20 weeks assessment |
| Change in Child Anxiety and Depression Symptoms as Assessed by RCADS-25 (Child and Parent Versions) | Total scores from the Revised Children's Anxiety and Depression Scale - Short Version (RCADS-25) will be used to assess anxiety and depressive symptoms in children and adolescents. Higher scores indicate greater symptom severity. | Baseline; 12 weeks; 20 weeks assessment |
| Suicidal Ideation and Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | Scores from the Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to assess severity and frequency of suicidal ideation and behavior in adults and children. The C-SSRS ideation severity subscale is scored on a 5-point ordinal scale ranging from 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), with higher scores indicating greater severity of suicidal ideation and a worse clinical outcome. | Baseline; weekly during treatment; 20 weeks assessment |
| Change in Family Functioning as Assessed by Family Adaptability and Cohesion Scale (FACES-IV-SF) | Total scores from the Family Adaptability and Cohesion Scale - Short Form (FACES-IV-SF) will be used to assess family functioning. Higher scores indicate healthier family dynamics. | Baseline; 12 weeks; 20 weeks assessment |
| Change in Parenting Competence as Assessed by Parenting Sense of Competency Scale (PSCS) | Total scores from the Parenting Sense of Competency Scale (PSCS) will be used to assess parental efficacy and satisfaction. Higher scores indicate greater perceived parenting competence. | Baseline; 12 weeks; 20 weeks assessment |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| 22393180 | Background | 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. |
| 29921145 | Background | 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. |
| 23702449 | Background | 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. |
| 17420684 | Background | 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. |
| 15928281 | Background | 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. |
| 25250737 | Background | 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. |
| 27276373 | Background | 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. |
| 24021502 | Background | 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. |