- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01008189
6-Year Follow-up of a Prevention Program for Bereaved Families
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
Arizona
-
Tempe, Arizona, Förenta staterna, 85287
- Prevention Research Center Arizona State University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Self study comparison group
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
|
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
|
|
Experimentell: Family Bereavement Program
12- session group for caregivers and bereaved children and adolescents plus 2 individual sessions
|
12 session groups for caregivers and bereaved children and adolescents plus two individual sessions
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Diagnostic Interview Schedule for Children (DISC)
Tidsram: One year
|
One year
|
|
Child Behavior Checklist and Young Adult Behavior Checklist
Tidsram: one year
|
one year
|
|
Youth Self Report (YSR)and Young Adult Self Report (YASR)
Tidsram: one year
|
one year
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Monitoring the Future - substance use
Tidsram: one year
|
one year
|
|
Rosenberg Self-esteem scale
Tidsram: one year
|
one year
|
|
Beck Depression Inventory for parents
Tidsram: One week
|
One week
|
|
Social and academic competence
Tidsram: one year
|
one year
|
|
Grade point average
Tidsram: one year
|
one year
|
|
Cortisol
Tidsram: 45 minutes
|
45 minutes
|
|
Parent and child report of parenting
Tidsram: One year
|
One year
|
|
Grief - TRIG, Intrusive Grief Thoughts Scale, Inventory of Complicated Grief
Tidsram: one month
|
one month
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Irwin N Sandler, Ph.D., Arizona State University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R01MH049155 (U.S.S. NIH-anslag/kontrakt)
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