Clinical trial NCT01008189: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mental Disorders Diagnosed in Childhood
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-11-04
Enrollment: 244
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Diagnostic Interview Schedule for Children (DISC)
timeFrame: One year
measure: Child Behavior Checklist and Young Adult Behavior Checklist
timeFrame: one year
measure: Youth Self Report (YSR)and Young Adult Self Report (YASR)
timeFrame: one year
Secondary outcomes:
measure: Monitoring the Future - substance use
timeFrame: one year
measure: Rosenberg Self-esteem scale
timeFrame: one year
measure: Beck Depression Inventory for parents
timeFrame: One week
measure: Social and academic competence
timeFrame: one year
measure: Grade point average
timeFrame: one year
measure: Cortisol
timeFrame: 45 minutes
measure: Parent and child report of parenting
timeFrame: One year
measure: Grief - TRIG, Intrusive Grief Thoughts Scale, Inventory of Complicated Grief
timeFrame: one month
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Prevention Research Center Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Irwin N Sandler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.