Back to results6-Year Follow-up of a Prevention Program for Bereaved Families
Primary Purpose
Mental Disorders Diagnosed in Childhood
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Self- study comparison group
Family Bereavement Program
Sponsored by
About this trial
This is an interventional prevention trial for Mental Disorders Diagnosed in Childhood
Eligibility Criteria
Inclusion Criteria:
- Experienced parental death in prior 30 months
- Youth age 8-16 years old
Exclusion Criteria:
- Not currently in other treatment for mental health problems
- Caregiver not meet criteria for clinical depression
- Youth not meet criteria for externalizing problems
- Not currently suicidal
Sites / Locations
- Prevention Research Center Arizona State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Self study comparison group
Family Bereavement Program
Arm Description
Caregivers and children and adolescents each received three books about coping with grief after the death of a loved one and a syllabus to guide reading
12- session group for caregivers and bereaved children and adolescents plus 2 individual sessions
Outcomes
Primary Outcome Measures
Diagnostic Interview Schedule for Children (DISC)
Child Behavior Checklist and Young Adult Behavior Checklist
Youth Self Report (YSR)and Young Adult Self Report (YASR)
Secondary Outcome Measures
Monitoring the Future - substance use
Rosenberg Self-esteem scale
Beck Depression Inventory for parents
Social and academic competence
Grade point average
Cortisol
Parent and child report of parenting
Grief - TRIG, Intrusive Grief Thoughts Scale, Inventory of Complicated Grief
Full Information
NCT ID
NCT01008189
First Posted
September 24, 2009
Last Updated
November 3, 2009
Sponsor
Arizona State University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01008189
Brief Title
6-Year Follow-up of a Prevention Program for Bereaved Families
Official Title
6-Year Follow-up of a Prevention Program for Bereaved Families
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Arizona State University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Six-years following participation in the Family Bereavement Program (FBP) participants in the program as compared to a self-study control group will have lower levels of mental health problems, lower one-year prevalence of mental disorder that meets diagnostic criteria, lower use of substances, higher levels of competence at achieving developmentally appropriate tasks in academic achievement and social competence, and better self-esteem. The effects of the FBP will be moderated by baseline levels of mental health problems and gender. Bereaved caregivers who participated in the program will also show lower levels of mental health problems as compared with controls.
Program effects will be mediated by theoretical mediators targeted by the program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders Diagnosed in Childhood
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self study comparison group
Arm Type
Active Comparator
Arm Description
Caregivers and children and adolescents each received three books about coping with grief after the death of a loved one and a syllabus to guide reading
Arm Title
Family Bereavement Program
Arm Type
Experimental
Arm Description
12- session group for caregivers and bereaved children and adolescents plus 2 individual sessions
Intervention Type
Behavioral
Intervention Name(s)
Self- study comparison group
Intervention Description
Caregivers, children and adolescents each received three books about coping with grief following the death of a loved one plus a syllabus to guide reading
Intervention Type
Behavioral
Intervention Name(s)
Family Bereavement Program
Intervention Description
12 session groups for caregivers and bereaved children and adolescents plus two individual sessions
Primary Outcome Measure Information:
Title
Diagnostic Interview Schedule for Children (DISC)
Time Frame
One year
Title
Child Behavior Checklist and Young Adult Behavior Checklist
Time Frame
one year
Title
Youth Self Report (YSR)and Young Adult Self Report (YASR)
Time Frame
one year
Secondary Outcome Measure Information:
Title
Monitoring the Future - substance use
Time Frame
one year
Title
Rosenberg Self-esteem scale
Time Frame
one year
Title
Beck Depression Inventory for parents
Time Frame
One week
Title
Social and academic competence
Time Frame
one year
Title
Grade point average
Time Frame
one year
Title
Cortisol
Time Frame
45 minutes
Title
Parent and child report of parenting
Time Frame
One year
Title
Grief - TRIG, Intrusive Grief Thoughts Scale, Inventory of Complicated Grief
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Experienced parental death in prior 30 months
Youth age 8-16 years old
Exclusion Criteria:
Not currently in other treatment for mental health problems
Caregiver not meet criteria for clinical depression
Youth not meet criteria for externalizing problems
Not currently suicidal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irwin N Sandler, Ph.D.
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prevention Research Center Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12795581
Citation
Sandler IN, Ayers TS, Wolchik SA, Tein JY, Kwok OM, Haine RA, Twohey-Jacobs J, Suter J, Lin K, Padgett-Jones S, Weyer JL, Cole E, Kriege G, Griffin WA. The family bereavement program: efficacy evaluation of a theory-based prevention program for parentally bereaved children and adolescents. J Consult Clin Psychol. 2003 Jun;71(3):587-600. doi: 10.1037/0022-006x.71.3.587.
Results Reference
background
PubMed Identifier
32720190
Citation
Danvers AF, Scott BG, Shiota MN, Tein JY, Wolchik SA, Sandler II. Effects of Therapeutic Intervention on Parentally Bereaved Children's Emotion Reactivity and Regulation 15 Years Later. Prev Sci. 2020 Nov;21(8):1017-1027. doi: 10.1007/s11121-020-01142-2.
Results Reference
derived
PubMed Identifier
27427807
Citation
Sandler I, Tein JY, Cham H, Wolchik S, Ayers T. Long-term effects of the Family Bereavement Program on spousally bereaved parents: Grief, mental health problems, alcohol problems, and coping efficacy. Dev Psychopathol. 2016 Aug;28(3):801-18. doi: 10.1017/S0954579416000328.
Results Reference
derived
PubMed Identifier
20921347
Citation
Sandler I, Ayers TS, Tein JY, Wolchik S, Millsap R, Khoo ST, Kaplan D, Ma Y, Luecken L, Schoenfelder E, Coxe S. Six-year follow-up of a preventive intervention for parentally bereaved youths: a randomized controlled trial. Arch Pediatr Adolesc Med. 2010 Oct;164(10):907-14. doi: 10.1001/archpediatrics.2010.173.
Results Reference
derived
Learn more about this trial
6-Year Follow-up of a Prevention Program for Bereaved Families
We'll reach out to this number within 24 hrs