- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00239837
Prevention Program for Problem Behaviors in Girls in Foster Care
Preventing Problems for Girls in Foster Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The transition from elementary school to middle school presents a complex set of challenges for adolescents. These include increased expectations for time management and self-monitoring, renegotiation of rules and boundaries with parents, increased peer influence, and pubertal changes. For children in foster care, this transition is further complicated by issues such as a possible history of maltreatment, unpredictable changes in their living situations, and difficulty explaining their foster care background to peers and teachers. Such issues may be more serious for girls in foster care. Social problems for these girls in middle school can lead to a number of negative effects, including delinquency, substance abuse, poor school performance, mental health problems, and participation in risky sexual behavior. Despite such risks, adolescent girls are less likely to receive specialty mental health or school-based services than their male counterparts. This study is aimed at determining the effectiveness of a preventive intervention for preadolescent girls living in foster/kinship care. The intervention targets include preventing delinquency, initiation of substance use, participation in risky sexual behavior, school truancy and failure, and mental health problems.
Participants were randomly assigned to receive either the preventive intervention or usual foster care services in the summer before entering middle school (typically sixth grade). The preventive intervention consisted of weekly training and support sessions for both participants and their foster or kin parents. The sessions began at study start and continued throughout participants' first year in middle school. Participants' relationship development, delinquency, school behavior and performance, sexual behavior, and substance use were assessed through questionnaires. Parenting practices were assessed through interviews. Assessments were conducted at study entry and at Months 6, 12, and 24, and 36. A new, follow-up assessment on the girls' decision making was conducted at age 14-16.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Eugene, Oregon, United States, 97401
- Oregon Social Learning Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Living in a foster home or receiving kinship care
- Are about to enter middle school
- Oregon resident
- Guardian willing to provide informed consent
- Female
Exclusion Criteria:
- male
- not in foster care
- not living in Oregon
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Middle School Success Intervention (MSS)
Middle School Success Intervention (MSS): Participants receive the preventative intervention
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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.
Other Names:
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No Intervention: Foster Care Services as Usual
Foster Care Services as Usual: Participants continue with usual foster care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delinquency
Time Frame: Measured at Month 36
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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.
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Measured at Month 36
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Tobacco Use
Time Frame: Measured at Month 36
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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.
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Measured at Month 36
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Marijuana Use
Time Frame: Measured at Month 36
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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.
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Measured at Month 36
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental Health Problems
Time Frame: Measured at Months 12 and 24
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Internalizing and externalizing symptoms at 12 and 24 months were measured with caregiver report on the Achenbach System of Empirically Based Assessment (ASEBA).
This widely used checklist for psychopathological behaviors includes scales for behaviors such as Anxious/Depressed; Withdrawn; Somatic Complaints; Thought Problems; Attention Problems; Aggressive Behavior; Rule-Breaking Behavior; and Intrusive.
The ASEBA has been shown to have both construct and content validity in the literature.
For the present study, raw scores for the internalizing and externalizing symptoms subscales were used.
Scores at 12 and 24 months were combined and averaged (mean).
Units on a scale.
Range = 0-66.
Higher scores indicate higher levels of internalizing or externalizing problems.
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Measured at Months 12 and 24
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Participation in Risky Sexual Behaviors
Time Frame: Measured at Month 36
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Eight items from the girls' in-person interviews were used to assess health risking sexual behavior at the 36-month followup.
The girls reported on items such as touching a boy's body above or below the waist, having sexual intercourse, having sex with someone who they just met, or having sex with someone using drugs in the past 12 months.
Positive answers to these items were totaled to represent the cumulative number of health-risking sexual behaviors.
The frequency of the cumulative number of risky sexual acts ranged from 0 to 7. Units on a scale.
Higher scores indicate more health-risking sexual behaviors.
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Measured at Month 36
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Social Competence
Time Frame: Measured at Months 6, 12
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Prosocial behavior was measured with a subscale from the Parent Daily Report (PDR; Chamberlain & Reid, 1987).
The PDR was administered individually by telephone to foster parents on 3 consecutive or closely spaced days (1-3 days apart) at each assessment.
A trained interviewer asked the foster parent whether a list of prosocial behaviors took place during the previous 24 hr (yes/no format).
The prosocial scale was computed based on nine items, such as "cleans up after herself" and "do a favor for someone."
The PDR was designed to avoid the potential bias of aggregate recall of frequency estimates.
Studies have reported concurrent and predictive validity of the PDR checklist.
The scores were averaged (mean) across calls from 3 days.
Scores on prosocial behavior at 6 and 12 months were averaged and the mean across both time points was used in analysis.
Units on a scale.
Range = 0-9.
Higher scores indicate more prosocial behavior.
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Measured at Months 6, 12
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Placement Changes
Time Frame: Measured at Months 6 and 12
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Child welfare system records were collected at each assessment to determine the girls' placement changes (including the number and type of changes).
Placement changes since the start of the study through 12 months were summed for each girl.
The number of placement changes ranged from 0 to 7 during this period.
Units on a scale.
Higher scores indicate more placement changes.
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Measured at Months 6 and 12
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Decision Making
Time Frame: Measured at age 15-17
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"Cups" task (Weller et al., 2007).
On each trial, participants see 2 arrays with equal number of X cups (2, 3, or 5) each.
On gain trials, participants informed that under each cup in one array is 1 quarter, and the other array includes 1 cup with Y quarters (either 2, 3, or 5), but the other cups have 0 quarters.
Choosing from the riskless side leads to a sure gain of 1 quarter while choosing the risky side can lead to gain of Y quarters or no quarters.
On loss trials, participants shown that choosing cup from 1 array will lead to 1 quarter taken away while choosing cup from other array will lead to no quarters or Y quarters taken.
Cups task consists of 54 trials of 3 trials each of all combinations of 2 levels of domain (gain, loss).
Expected Value Sensitivity (EV) calculated by subtracting proportion of risky choices made when EV actually favored the sure choice from proportion of risky choices made on trials where EV favored risky option.
Score can range from -1.0 to -1.0.
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Measured at age 15-17
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leslie Leve, PhD, University of Oregon
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH054257 (U.S. NIH Grant/Contract)
- R21DA027091 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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