Juvenile Justice InvolvementNCT00239837
Prevention Program for Problem Behaviors in Girls in Foster Care
A study testing Middle School Success Intervention (MSS) in people with Juvenile Justice Involvement and Drug Abuse, run by Oregon Social Learning Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 10 to 12 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Juvenile Justice Involvement, Drug Abuse
- What is being tested?
- Middle School Success Intervention (MSS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Living in a foster home or receiving kinship care
- Are about to enter middle school
- Oregon resident
- Guardian willing to provide informed consent
- Female
Who cannot join
- male
- not in foster care
- not living in Oregon
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Problems for Girls in Foster Care
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.
- Conditions
- Juvenile Justice Involvement, Drug Abuse
- Being tested
- Middle School Success Intervention (MSS)
- Keywords
- Adolescent, Foster Care, Female
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle School Success Intervention (MSS)Behavioural
Also called KEEP SAFE
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.
| Study group | Role | What they receive |
|---|---|---|
| Middle School Success Intervention (MSS) | Experimental | Middle School Success Intervention (MSS): Participants receive the preventative intervention Receives: Behavioral: Middle School Success Intervention (MSS) |
| Foster Care Services as Usual | No intervention | Foster Care Services as Usual: Participants continue with usual foster care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: Measured at Month 36
Secondary outcomes (5)
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.
Measured: Measured at Months 12 and 24
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.
Measured: Measured at Month 36
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.
Measured: Measured at Months 6, 12
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.
Measured: Measured at Months 6 and 12
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.
Measured: Measured at age 15-17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startDec 2003
- Primary completionDec 2009
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Juvenile Justice InvolvementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Social Learning Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Leslie D. Leve, Oregon Social Learning Center
- Investigators
- Leslie Leve, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239837
- Sponsor's protocol ID
- R01MH054257
- Other IDs
- R01MH054257, R21DA027091
- Status last verified
- Feb 2022
- First submitted
- 13 Oct 2005
- Last updated
- 4 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 18176629Mendle 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 22337616Natsuaki 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 21184260Smith 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 21475990Kim 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 22004305Mendle 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 25419091Kim 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 24043921Weller 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Problems for Girls in Foster Care
- ClinicalTrials.gov ID
- NCT00239837
- Acronym / sponsor ID
- R01MH054257
- Conditions
- Juvenile Justice Involvement, Drug Abuse
- Keywords
- Adolescent, Foster Care, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Posted 31 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Middle School Success Intervention (MSS) | Experimental | Behavioral: Middle School Success Intervention (MSS)Middle School Success Intervention (MSS): Participants receive the preventative intervention |
| Foster Care Services as Usual | No intervention | –Foster Care Services as Usual: Participants continue with usual foster care |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Living in a foster home or receiving kinship care
- Are about to enter middle school
- Oregon resident
- Guardian willing to provide informed consent
- Female
Key exclusion criteria (3 listed)
- male
- not in foster care
- not living in Oregon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Middle School Success Intervention (MSS)Also: KEEP SAFEThis 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. | Behavioural | Middle School Success Intervention (MSS) |
Primary outcome
Delinquency
Time frame: Measured at Month 36
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.
Tobacco Use
Time frame: Measured at Month 36
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.
Marijuana Use
Time frame: Measured at Month 36
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.
5 secondary outcomes
Mental Health Problems
Time frame: Measured at Months 12 and 24
Participation in Risky Sexual Behaviors
Time frame: Measured at Month 36
Social Competence
Time frame: Measured at Months 6, 12
Placement Changes
Time frame: Measured at Months 6 and 12
Decision Making
Time frame: Measured at age 15-17
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18176629Chamberlain 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.
- Results publication: PubMed 22337616Mendle 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.
- Results publication: PubMed 21184260Natsuaki 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.
- Results publication: PubMed 21475990Smith 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.
- Results publication: PubMed 22004305Kim 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.
- Results publication: PubMed 25419091Mendle 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.
- Results publication: PubMed 24043921Kim 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.
- Results publication: PubMed 25997770Weller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Leve, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Middle School Success Intervention (MSS) in people with Juvenile Justice Involvement and Drug Abuse, run by Oregon Social Learning Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delinquency (time frame: Measured at Month 36). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00239837, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.