Prolonged Grief Disorder (PGD)F-PGTNCT07318090
F-PGT - Prolonged Grief Treatment for Families Affected by Suicide
A study testing F-PGT in people with Prolonged Grief Disorder (PGD), run by University of Pittsburgh at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Prolonged Grief Disorder (PGD)
- What is being tested?
- F-PGT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Columbia University
New York, New York, 10032
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Developing a Family-Focused Treatment for Prolonged Grief for Parental Suicide Bereaved Families With Children
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.
Read the 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.
- Conditions
- Prolonged Grief Disorder (PGD)
- Being tested
- F-PGT
- Keywords
- Prolonged Grief Disorder, Suicide loss survivor, Family treatment, Prolonged Grief Treatment, Grief
- Medical subject headings
- Prolonged Grief Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-PGTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| F-PGT | Experimental | Eligible families will receive 16 online sessions of Family-Prolonged Grief Treatment (F-PGT). Receives: Behavioral: F-PGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of treatment at 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start17 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Prolonged Grief Disorder (PGD)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention, Columbia University
- Responsible party
- Principal investigator, Nadine Melhem, University of Pittsburgh
- Investigators
- Nadine A Melhem, PhD, Principal investigator, University of PittsburghM. Katherine Shear, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318090
- Sponsor's protocol ID
- STUDY23070021 (Aim 3)
- Other IDs
- LSRG-0-080-22
- Acronym
- F-PGT
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not required by the funding agency.
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.
PubMed 18458185Melhem 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.
PubMed 21893658Hamdan 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.
PubMed 22393180Pham 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.
PubMed 29921145Melhem 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.
PubMed 23702449Melhem 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.
PubMed 17420684Shear 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.
PubMed 15928281Shear 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.
PubMed 25250737Shear 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.
PubMed 27276373Hamdan 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.
PubMed 24021502
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Family-Focused Treatment for Prolonged Grief for Parental Suicide Bereaved Families With Children
- ClinicalTrials.gov ID
- NCT07318090
- Acronym / sponsor ID
- F-PGT / STUDY23070021 (Aim 3)
- Conditions
- Prolonged Grief Disorder (PGD)
- Keywords
- Prolonged Grief Disorder, Suicide loss survivor, Family treatment, Prolonged Grief Treatment, Grief
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention, Columbia University
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open trial
| Arm | Type | Receives |
|---|---|---|
| F-PGT | Experimental | Behavioral: F-PGTEligible families will receive 16 online sessions of Family-Prolonged Grief Treatment (F-PGT). |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-PGTFamily- 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. | Behavioural | F-PGT |
Primary outcome
Total Score on Feasibility of Intervention Measure (FIM) at End of Treatment
Time frame: End 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 Treatment
Time frame: End 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 Score
Time frame: Baseline; 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 Score
Time frame: Baseline; 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) Scores
Time frame: Baseline; 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.
19 secondary outcomes
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
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
Time frame: Baseline
Change in Observed Parent-Child Communication Behaviors During Virtual Interaction Tasks
Time frame: End of treatment at 20 weeks
Observed Parent-Child Attachment Behaviors During Virtual Interaction Tasks
Time frame: Baseline
Change in Observed Parent-Child Attachment Behaviors During Virtual Interaction Tasks
Time frame: End of treatment at 20 weeks
Observed Parent and Child Reflective Functioning During Virtual Interaction Tasks
Time frame: Baseline
Change in Observed Parent and Child Reflective Functioning During Virtual Interaction Tasks
Time frame: End of treatment at 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 18458185Melhem 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.
- Background: PubMed 21893658Melhem 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.
- Background: PubMed 22393180Hamdan 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.
- Background: PubMed 29921145Pham 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.
- Background: PubMed 23702449Melhem 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.
- Background: PubMed 17420684Melhem 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.
- Background: PubMed 15928281Shear 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.
- Background: PubMed 25250737Shear 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.
- Background: PubMed 27276373Shear 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.
- Background: PubMed 24021502Hamdan 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.
- Individual participant dataSharing planned: No. Not required by the funding agency.
Related trials for Prolonged Grief Disorder (PGD)
Recruiting
Technology-supported Interventions for Prolonged Grief Disorder (PGD)
Prolonged Grief Disorder (PGD)
Recruiting
Emotion-Focused Therapy in the Treatment of Prolonged Grief Disorder
Prolonged Grief Disorder (PGD)
Recruiting
A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department
Grief Disorder, Prolonged
Not yet recruiting
Prolonged Grief Disorder (PGD) Diagnosis in Older Adults: Physicians' Knowledge and Practice
Physicians' Knowledge and Diagnostic Practices for PGD in Older Adults, Effect of Brief Training on PGD Diagnosis
Not yet recruiting
Understanding and Responding to Grief-Related Needs: A Differentiated Community Approach
Prolonged Grief Disorder (PGD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadine A Melhem, PhD principal investigator
University of Pittsburgh
M. Katherine Shear, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-PGT in people with Prolonged Grief Disorder (PGD), run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Score on Feasibility of Intervention Measure (FIM) at End of Treatment (time frame: End of treatment at 20 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07318090, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.