NCT00239837

Brief Summary

This study will determine the efficacy of a parent-involved intervention in preventing problem behavior in middle school girls who are currently in foster care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 31, 2014

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

6 years

First QC Date

October 13, 2005

Results QC Date

May 6, 2013

Last Update Submit

February 23, 2022

Conditions

Juvenile Justice InvolvementDrug Abuse

Keywords

AdolescentFoster CareFemale

Outcome Measures

Primary Outcomes (3)

  • Delinquency

    36 items from the general delinquency scale from the Self-Report Delinquency Scale (SRD; Elliott, Huizinga, \& Ageton, 1985). Units on a scale. Girls were asked to rate how many times they had committed various delinquent acts (e.g., damaging or destroying properties, and stealing) in the past year, using an open-ended format. The mean of frequencies across these items was used to represent the level of delinquency for girls. The general delinquency scale scores ranged from 0 to 24 (full scale) and from 0 to 13 (log transformed). Higher scores indicate higher levels of delinquency.

    Measured at Month 36

  • Tobacco Use

    The girls were asked how many times in the past year they had smoked cigarettes or chewed tobacco. The response scale ranged from 1 (never) through 9 (daily). Units on a scale.

    Measured at Month 36

  • Marijuana Use

    The girls were asked how many times in the past year they had used marijuana. The response scale ranged from 1 (never) through 9 (daily). Units on a scale. Log transformed.

    Measured at Month 36

Secondary Outcomes (5)

  • Mental Health Problems

    Measured at Months 12 and 24

  • Participation in Risky Sexual Behaviors

    Measured at Month 36

  • Social Competence

    Measured at Months 6, 12

  • Placement Changes

    Measured at Months 6 and 12

  • Decision Making

    Measured at age 15-17

Study Arms (2)

Middle School Success Intervention (MSS)

EXPERIMENTAL

Middle School Success Intervention (MSS): Participants receive the preventative intervention

Behavioral: Middle School Success Intervention (MSS)

Foster Care Services as Usual

NO INTERVENTION

Foster Care Services as Usual: Participants continue with usual foster care

Interventions

Middle School Success Intervention (MSS)BEHAVIORAL

This is a 10-month, psychosocial intervention for foster parents and girls, with administration of the intervention beginning the summer before entry into middle school. The intervention consists of: (1) six summer Pride groups for the girls, (2) six summer parenting intervention sessions for the foster parents; (3) weekly foster parent training and support sessions for foster parents during the first year of middle school; and (4) weekly individual skills training for the girls during the first year of middle school.

Also known as: KEEP SAFE
Middle School Success Intervention (MSS)

Eligibility Criteria

Age10 Years - 12 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Living in a foster home or receiving kinship care
  • Are about to enter middle school
  • Oregon resident
  • Guardian willing to provide informed consent
  • Female

You may not qualify if:

  • male
  • not in foster care
  • not living in Oregon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Social Learning Center

Eugene, Oregon, 97401, United States

Location

Related Publications (8)

  • Chamberlain P, Leve LD, Smith DK. Preventing Behavior Problems and Health-risking Behaviors in Girls in Foster Care. Int J Behav Consult Ther. 2006;2(4):518-530. doi: 10.1037/h0101004.

    PMID: 18176629BACKGROUND

  • Mendle J, Leve LD, Van Ryzin M, Natsuaki MN, Ge X. Associations Between Early Life Stress, Child Maltreatment, and Pubertal Development Among Girls in Foster Care. J Res Adolesc. 2011 Dec 1;21(4):871-880. doi: 10.1111/j.1532-7795.2011.00746.x.

    PMID: 22337616RESULT

  • Natsuaki MN, Leve LD, Mendle J. Going through the rites of passage: timing and transition of menarche, childhood sexual abuse, and anxiety symptoms in girls. J Youth Adolesc. 2011 Oct;40(10):1357-70. doi: 10.1007/s10964-010-9622-6. Epub 2010 Dec 24.

    PMID: 21184260RESULT

  • Smith DK, Leve LD, Chamberlain P. Preventing internalizing and externalizing problems in girls in foster care as they enter middle school: impact of an intervention. Prev Sci. 2011 Sep;12(3):269-77. doi: 10.1007/s11121-011-0211-z.

    PMID: 21475990RESULT

  • Kim HK, Leve LD. Substance use and delinquency among middle school girls in foster care: a three-year follow-up of a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):740-50. doi: 10.1037/a0025949. Epub 2011 Oct 17.

    PMID: 22004305RESULT

  • Mendle J, Leve LD, Van Ryzin M, Natsuaki MN. Linking Childhood Maltreatment with Girls' Internalizing Symptoms: Early Puberty as a Tipping Point. J Res Adolesc. 2014 Dec 1;24(4):689-702. doi: 10.1111/jora.12075.

    PMID: 25419091RESULT

  • Kim HK, Pears KC, Leve LD, Chamberlain PC, Smith DK. Intervention Effects on Health-Risking Sexual Behavior Among Girls in Foster Care: The Role of Placement Disruption and Tobacco and Marijuana Use. J Child Adolesc Subst Abuse. 2013 Nov 1;22(5):370-387. doi: 10.1080/1067828X.2013.788880.

    PMID: 24043921RESULT

  • Weller JA, Leve LD, Kim HK, Bhimji J, Fisher PA. Plasticity of risky decision making among maltreated adolescents: Evidence from a randomized controlled trial. Dev Psychopathol. 2015 May;27(2):535-51. doi: 10.1017/S0954579415000140.

    PMID: 25997770RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Limitations and Caveats

Sample is relatively small in size, and limited to girls in foster care in two Oregon Counties

Results Point of Contact

Title
Dr Leslie Leve
Organization
University of Oregon
leve@uoregon.edu
541-346-9528

Study Officials

  • Leslie Leve, PhD

    University of Oregon

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Fellow

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

December 1, 2003

Primary Completion

December 1, 2009

Study Completion

April 1, 2013

Last Updated

March 4, 2022

Results First Posted

March 31, 2014

Record last verified: 2022-02

Locations

US(1)