6-Year Follow-up of a Prevention Program for Bereaved Families

Mental Disorders Diagnosed in Childhood Clinical Trial

Official title:

6-Year Follow-up of a Prevention Program for Bereaved Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008189
• Other study ID #: R01MH049155
• Secondary ID: R01MH049155
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2009
• Last updated: November 3, 2009
• Start date: January 1996
• Est. completion date: July 2009

Study information

• Verified date: November 2009
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: July 2009
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mental Disorders
• Mental Disorders Diagnosed in Childhood
• Psychotic Disorders

Intervention

Behavioral:
• Self- study comparison group
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
• Family Bereavement Program
12 session groups for caregivers and bereaved children and adolescents plus two individual sessions

Locations

Country	Name	City	State
United States	Prevention Research Center Arizona State University	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Interview Schedule for Children (DISC)		One year	No
Primary	Child Behavior Checklist and Young Adult Behavior Checklist		one year	No
Primary	Youth Self Report (YSR)and Young Adult Self Report (YASR)		one year	No
Secondary	Monitoring the Future - substance use		one year	No
Secondary	Rosenberg Self-esteem scale		one year	No
Secondary	Beck Depression Inventory for parents		One week	No
Secondary	Social and academic competence		one year	No
Secondary	Grade point average		one year	No
Secondary	Cortisol		45 minutes	No
Secondary	Parent and child report of parenting		One year	No
Secondary	Grief - TRIG, Intrusive Grief Thoughts Scale, Inventory of Complicated Grief		one month	No