Developing a Family-Focused Treatment for Prolonged Grief for Parental Suicide Bereaved Families With Children
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Total Score on Feasibility of Intervention Measure (FIM) at End of Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
F-PGT
Eligible families will receive 16 online sessions of Family-Prolonged Grief Treatment (F-PGT).
干预措施: F-PGT (Behavioral)
结局指标
主要结局
Total Score on Feasibility of Intervention Measure (FIM) at End of Treatment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Observed Parent-Child Communication Behaviors During Virtual Interaction Tasks(End of treatment at 20 weeks)
- Observed Parent-Child Attachment Behaviors During Virtual Interaction Tasks(Baseline)
- Change in Observed Parent-Child Attachment Behaviors During Virtual Interaction Tasks(End of treatment at 20 weeks)
- Observed Parent and Child Reflective Functioning During Virtual Interaction Tasks(Baseline)
- Change in Observed Parent and Child Reflective Functioning During Virtual Interaction Tasks(End of treatment at 20 weeks)
- Change in Child Global Assessment Scale (C-GAS) Total Score(Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment)
- Change in Work and Social Adjustment Scale (WSAS) Total Score(Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment)
- Change in Parental Reflective Functioning Questionnaire (PRFQ) Total Score(Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment)
- Change in Coping with Children's Negative Emotions Scale (CCNES) Total Score(Baseline; 20 weeks assessment)
- Change in Child and Adolescent Reflective Functioning Scale (CARFS) Score(Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment)
- Change in Child-Parent Relationship Scale (CPRS) Total Score(Baseline; 4 weeks; 12 weeks; 20 weeks assessment)
- Presence of Psychiatric Diagnoses as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)(Baseline)
- Change in Psychiatric Diagnoses as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)(End of treatment at 20 weeks)
- Presence of Psychiatric Diagnoses as Assessed by K-SADS-PL (Child and Parent Versions)(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)(End of treatment at 20 weeks)
- Total Score on Prolonged Grief Disorder-13 (PG-13) Scale(Baseline)
- Change in Total Score on Prolonged Grief Disorder-13 (PG-13) Scale(20 weeks assessment)
- Observed Parent-Child Communication Behaviors During Virtual Interaction Tasks(Baseline)
- Change in Child Global Assessment Scale (C-GAS) Total Score(Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment)
- Change in Global Assessment Scale (GAS) Total Score (Parent)(Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment)
- Change in Work and Social Adjustment Scale (WSAS) Total Score(Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment)
- Change in Parental Reflective Functioning Questionnaire (PRFQ) Total Score(Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment)
- Change in Coping with Children's Negative Emotions Scale (CCNES) Total Score(Baseline; 20 weeks assessment)
- Change in Child and Adolescent Reflective Functioning Scale (CARFS) Score(Baseline; 4, 8, 12, and 16 weeks of treatment; 20 weeks assessment)
- Change in Child-Parent Relationship Scale (CPRS) Total Score(Baseline; 4 weeks; 12 weeks; 20 weeks assessment)
- Presence of Psychiatric Diagnoses as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)(Baseline)
- Change in Psychiatric Diagnoses as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)(End of treatment at 20 weeks)
- Presence of Psychiatric Diagnoses as Assessed by K-SADS-PL (Child and Parent Versions)(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)(End of treatment at 20 weeks)
- Total Score on Prolonged Grief Disorder-13 (PG-13) Scale(Baseline)
- Change in Total Score on Prolonged Grief Disorder-13 (PG-13) Scale(20 weeks assessment)
- Observed Parent-Child Communication Behaviors During Virtual Interaction Tasks(Baseline)
- Change in Observed Parent-Child Communication Behaviors During Virtual Interaction Tasks(End of treatment at 20 weeks)
- Observed Parent-Child Attachment Behaviors During Virtual Interaction Tasks(Baseline)
- Change in Observed Parent-Child Attachment Behaviors During Virtual Interaction Tasks(End of treatment at 20 weeks)
- Observed Parent and Child Reflective Functioning During Virtual Interaction Tasks(Baseline)
- Change in Observed Parent and Child Reflective Functioning During Virtual Interaction Tasks(End of treatment at 20 weeks)
研究者
Nadine Melhem
Professor
University of Pittsburgh