CClinicalTrials.gg
CompletedNCT00239837Updated Mar 4, 2022Results posted

Prevention Program for Problem Behaviors in Girls in Foster Care

An interventional study of Middle School Success Intervention (MSS) in Juvenile Justice Involvement and Drug Abuse, sponsored by Oregon Social Learning Center. Completed at 1 site in United States. Open to female participants aged 10 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-04.

Sponsored by Oregon Social Learning Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
10 Years to 12 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Juvenile Justice Involvement
  • Drug Abuse

Keywords

  • Adolescent
  • Foster Care
  • Female
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 100 is close to the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Oregon Social Learning Center is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 12 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • male
  • not in foster care
  • not living in Oregon
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Middle School Success Intervention (MSS)

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

    Behavioral: Middle School Success Intervention (MSS)

  • No intervention
    Foster Care Services as Usual

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

Interventions

  • BehavioralMiddle School Success Intervention (MSS)

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Measured at Month 36

  2. 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.

    Time frame: Measured at Month 36

  3. 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.

    Time frame: Measured at Month 36

Secondary outcomes

  1. Mental Health Problems

    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.

    Time frame: Measured at Months 12 and 24

  2. Participation in Risky Sexual Behaviors

    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.

    Time frame: Measured at Month 36

  3. Social Competence

    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.

    Time frame: Measured at Months 6, 12

  4. Placement Changes

    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.

    Time frame: Measured at Months 6 and 12

  5. Decision Making

    "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.

    Time frame: Measured at age 15-17

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Results

Posted Mar 31, 2014
Limitations and caveats
Sample is relatively small in size, and limited to girls in foster care in two Oregon Counties

Participant flow

Child welfare staff members referred girls to the study between 2003-2006, by searching their database to gather information on all girls who were 10-12 years old, in their final year of elementary school, currently in foster care, and living in the targeted counties in Oregon.

Participant flow — Overall Study
Milestone1 - Intervention2 - Foster Care Services as Usual
Started4852
6 months4850
Completed4545
Not completed37
Withdrew: Lost to follow-up37

Outcome measures

PrimaryDelinquency

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.

Time frame:
Measured at Month 36
Reported as:
Mean · log(units on a scale)
Delinquency
log(units on a scale)1 - Intervention2 - Foster Care Services as Usual
Delinquency.30 ± .92.95 ± 2.69
SecondaryMental Health Problems

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.

Time frame:
Measured at Months 12 and 24
Reported as:
Mean · units on a scale
Mental Health Problems
units on a scale1 - Intervention2 - Foster Care Services as Usual
Mental Health Problems12.77 ± 8.5312.50 ± 8.29
SecondaryParticipation in Risky Sexual Behaviors

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.

Time frame:
Measured at Month 36
Reported as:
Mean · units on a scale
Participation in Risky Sexual Behaviors
units on a scale1 - Intervention2 - Foster Care Services as Usual
Participation in Risky Sexual Behaviors.89 ± 1.171.69 ± 2.04
SecondarySocial Competence

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.

Time frame:
Measured at Months 6, 12
Reported as:
Mean · units on a scale
Social Competence
units on a scale1 - Intervention2 - Foster Care Services as Usual
Social Competence.80 ± .12.74 ± .14
SecondaryPlacement Changes

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.

Time frame:
Measured at Months 6 and 12
Reported as:
Mean · placement changes
Placement Changes
placement changes1 - Intervention2 - Foster Care Services as Usual
Placement Changes.33 ± 1.05.76 ± 1.19
PrimaryTobacco 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.

Time frame:
Measured at Month 36
Reported as:
Mean · log(units on a scale)
Tobacco Use
log(units on a scale)1 - Intervention2 - Foster Care Services as Usual
Tobacco Use1.49 ± 1.632.36 ± 2.49
PrimaryMarijuana 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.

Time frame:
Measured at Month 36
Reported as:
Mean · log(units on a scale)
Marijuana Use
log(units on a scale)1 - Intervention2 - Foster Care Services as Usual
Marijuana Use1.29 ± .822.33 ± 2.43
SecondaryDecision Making

"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.

Time frame:
Measured at age 15-17
Reported as:
Mean · units on a scale
Decision Making
units on a scaleMiddle School Success Intervention (MSS)Foster Care Services as Usual
EV Sensitive in Loss Domain.1383 ± .22617.0378 ± .18861
EV Sensitivity in Gain Domain.2123 ± .2282.2743 ± .2429
Statistical analysis
  • Middle School Success Intervention (MSS) vs Foster Care Services as Usual · Regression, Logistic · p = .008 · Wald χ2: 7.14We began the analyses with a full-factorial model regressing choice on domain (gain=1, loss=0), the EV of the risky choice relative to the safe option (EV; range = -.38 to +.38), and dummy-coded treatment groups (Control= -1, Intervention =1).

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1 - Intervention—0/48 (0%)0/48 (0%)
2 - Foster Care Services as Usual—0/52 (0%)0/52 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)1 - Intervention2 - Foster Care Services as UsualTotal
<=18 years4852100
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)1 - Intervention2 - Foster Care Services as UsualTotal
Mean11.48 ± .5111.59 ± .4511.54 ± .48
Sex: Female, Male
Sex: Female, Male(Participants)1 - Intervention2 - Foster Care Services as UsualTotal
Female4852100
Male000
Region of Enrollment
Region of Enrollment(participants)1 - Intervention2 - Foster Care Services as UsualTotal
United States4852100
08

Study locations

1 site
  • Oregon Social Learning Center
    Eugene, Oregon 97401, United States
09

References and documents

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. PubMed 18176629 ↗
  • 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. PubMed 22337616 ↗
  • 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. PubMed 21184260 ↗
  • 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. PubMed 21475990 ↗
  • 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. PubMed 22004305 ↗
  • 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. PubMed 25419091 ↗
  • 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. PubMed 24043921 ↗
  • 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. PubMed 25997770 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00239837
Lead sponsor
Oregon Social Learning Center
Collaborators
National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)
Responsible party
Leslie D. Leve (Senior Fellow, Oregon Social Learning Center) — Principal investigator
First posted
Oct 17, 2005
Start date
Dec 2003
Primary completion
Dec 2009
Completion
Apr 2013
Results posted
Mar 31, 2014
Last update
Mar 4, 2022

Study contacts

Leslie Leve, PhD
principal investigator · University of Oregon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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