Juvenile Delinquency UnspecifiedSHARP-TeenNCT02420548
Safe, Healthy, Adolescent Relationships and Peers
A study testing Parent Ed. and Youth Skills Coaching and Services as Usual in people with Juvenile Delinquency Unspecified and Risk Behavior, run by University of Oregon at 1 site in United States.
Trial summary
The Safe, Healthy, Adolescent Relationships and Peers study seeks to understand some of the factors that contribute to the behaviors and health of teen girls, such as girl's friendships, their dating behaviors, their risk-taking behaviors, and their knowledge about how to make healthy choices. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women only
- Conditions the study is for
- Juvenile Delinquency Unspecified, Risk Behavior, Adolescent Behavior
- What is being tested?
- Parent Ed. and Youth Skills Coaching and Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2014to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- reside in Lane County and within 70 miles of the University of Oregon
- have a current caregiver
- both girl and caregiver are fluent in English
Who cannot join
- are medically fragile
- have a significant developmental disability
- have graduated from high school or have a General Educational Diploma (GED)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Drug Use and Risk Behaviors in Adolescent Girls
The Safe, Healthy, Adolescent Relationships and Peers study seeks to understand some of the factors that contribute to the behaviors and health of teen girls, such as girl's friendships, their dating behaviors, their risk-taking behaviors, and their knowledge about how to make healthy choices. This study will inform us on ways to help teen girls engage in safe and healthy relationships and adjustment.
Read the detailed description
Initiation of drug use and participation in sexual-risk behaviors such as having multiple sexual partners, unprotected sexual intercourse, and intercourse with drug users are all too common among girls with at-risk histories, such as those who have experienced poverty, abuse, neglect, or been in the juvenile justice system. Studies consistently find that these girls have disproportionately high rates of these problems that, in addition to increasing risk for negative outcomes, have other costly sequelae such as drug addiction, early pregnancy, sexually-transmitted infections (STIs) and HIV contraction, delinquency, and early mortality (e.g., Santelli et al., 2001; Stueve et al., 2005). In our prior work, the investigators showed that the investigators could prevent early onset sexual intercourse and tobacco and marijuana initiation in pre-teen girls in foster care. Although this intervention, delivered to girls who were 11-years old and had not yet entered middle school, demonstrated efficacy, the investigators know very little about how to prevent the more serious and costly sexual-risk and illicit drug use behaviors in at-risk girls during the high school years, a period of risk for engagement in such behaviors. This study builds from this prior work to develop a new intervention for teenage girls with early adversity.
- Conditions
- Juvenile Delinquency Unspecified, Risk Behavior, Adolescent Behavior, Sexual Behavior, Drug Use
- Being tested
- Parent Ed. and Youth Skills Coaching, Services as Usual
- Medical subject headings
- Risk-Taking, Adolescent Behavior, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Ed. and Youth Skills CoachingBehavioural
The experimental intervention will have two components: (1) a caregiver parenting group, including all caregiver types (biological, foster, kinship), that meets weekly for 90-minutes for four months, focused on increasing parenting skills, and (2) a Life Coach component where trained and supported skills coaches meet individually with youth weekly for 60 minutes over the same four-month period to build the girls' social skills and peer/partner relationships skills.
Services as UsualBehavioural
Services as usual as provided by community service organizations from which the sample was drawn.
| Study group | Role | What they receive |
|---|---|---|
| Services as Usual | Active comparator | Participants continue with any services they may be receiving outside of the study. Receives: Behavioral: Services as Usual |
| Parent Ed. and Youth Skills Coaching | Experimental | The experimental intervention will have two components: (1) a caregiver parenting group, including all caregiver types (biological, foster, kinship), that meets weekly for 90-minutes for four months, focused on increasing parenting skills, and (2) a Life Coach component where trained and supported skills coaches meet individually with youth weekly for 60 minutes over the same four-month period to build the girls' social skills and peer/partner relationships skills. Receives: Behavioral: Parent Ed. and Youth Skills Coaching; Behavioral: Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delinquency measured by official arrest records and standardized questionnaires
Reduction in delinquent behaviors for teens participating in the intervention arm measured by official arrest records and standardized questionnaires, including the Youth Symptom inventory, the Elliott Self-report Delinquency Scale, the Achenbach System of Empirically Based Assessment, and the Parent Daily Report.
Measured: Up to 12 months
Sexual Risk Behavior
Reduction in high risk sexual behaviors for teens participating in the intervention arm measured by standardized questionnaires, including Partner and Peer Behavior, Conflict in Adolescent Dating, Sexual Health Scale, and the Parent Daily Report.
Measured: Up to 12 months
Secondary outcomes (2)
Parenting measured by change in parenting practices for parents participating in the intervention arm measured by standardized questionnaires
including the Monitoring and Parent-Child Relationship, the Parent Practices Scale, the Parent Daily Report, and the Unrevealed Differences Questionnaire.
Measured: Up to 12 months
Substance Use
Reduction in substance use for teens participating in the intervention arm measured by urine analysis and standardized questionnaires, including the Youth Symptom Inventory, the World Health Organization Composite International Diagnostic Interview, and the Parent Daily Report.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study start1 Jul 2014
- Primary completion31 Aug 2019
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Juvenile Delinquency UnspecifiedStudies 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Social Learning Center, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Leslie Leve, PhD, Principal investigator, University of OregonPatti Chamberlain, PhD, Principal investigator, Oregon Social Learning CenterRohanna Buchanan, PhD, Study director, Oregon Social Learning Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420548
- Sponsor's protocol ID
- 10312013.040
- Other IDs
- 1P50DA035763
- Acronym
- SHARP-Teen
- Status last verified
- May 2023
- First submitted
- 14 Apr 2015
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Completely de-identified data shared. Interested investigators must secure IRB approval or waiver from their institution and cerfiy that they will not attempt to discern the identity of any participant.
Publications
Horn SR, Leve LD, Levitt P, Fisher PA. Childhood adversity, mental health, and oxidative stress: A pilot study. PLoS One. 2019 Apr 26;14(4):e0215085. doi: 10.1371/journal.pone.0215085. eCollection 2019.
PubMed 31026258Clark M, Buchanan R, Kovensky R, Leve LD. Partner influences on young women's risky drug and sexual behavior. Reprod Health. 2018 Sep 15;15(1):156. doi: 10.1186/s12978-018-0598-0.
PubMed 30219076Clark M, Buchanan R, Leve LD. Young Women's Perspectives of Their Adolescent Treatment Programs: A Qualitative Study. Int J Environ Res Public Health. 2018 Feb 22;15(2):373. doi: 10.3390/ijerph15020373.
PubMed 29470424Kovensky R, Anderson D, Leve LD. Early Adversity and Sexual Risk in Adolescence: Externalizing Behaviors as a Mediator. J Child Adolesc Trauma. 2019 Aug 7;13(2):173-184. doi: 10.1007/s40653-019-00278-w. eCollection 2020 Jun.
PubMed 32549929
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Drug Use and Risk Behaviors in Adolescent Girls
- ClinicalTrials.gov ID
- NCT02420548
- Acronym / sponsor ID
- SHARP-Teen / 10312013.040
- Conditions
- Juvenile Delinquency Unspecified, Risk Behavior, Adolescent Behavior, Sexual Behavior, Drug Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- Oregon Social Learning Center, National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Safe, Healthy, Adolescent Relationships and Peers study seeks to understand some of the factors that contribute to the behaviors and health of teen girls, such as girl's friendships, their dating behaviors, their risk-taking behaviors, and their knowledge about how to make healthy choices. This study will inform us on ways to help teen girls engage in safe and healthy relationships and adjustment.
Detailed description
Initiation of drug use and participation in sexual-risk behaviors such as having multiple sexual partners, unprotected sexual intercourse, and intercourse with drug users are all too common among girls with at-risk histories, such as those who have experienced poverty, abuse, neglect, or been in the juvenile justice system. Studies consistently find that these girls have disproportionately high rates of these problems that, in addition to increasing risk for negative outcomes, have other costly sequelae such as drug addiction, early pregnancy, sexually-transmitted infections (STIs) and HIV contraction, delinquency, and early mortality (e.g., Santelli et al., 2001; Stueve et al., 2005). In our prior work, the investigators showed that the investigators could prevent early onset sexual intercourse and tobacco and marijuana initiation in pre-teen girls in foster care. Although this intervention, delivered to girls who were 11-years old and had not yet entered middle school, demonstrated efficacy, the investigators know very little about how to prevent the more serious and costly sexual-risk and illicit drug use behaviors in at-risk girls during the high school years, a period of risk for engagement in such behaviors. This study builds from this prior work to develop a new intervention for teenage girls with early adversity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Services as Usual | Active comparator | Behavioral: Services as UsualParticipants continue with any services they may be receiving outside of the study. |
| Parent Ed. and Youth Skills Coaching | Experimental | Behavioral: Parent Ed. and Youth Skills Coaching, Behavioral: Services as UsualThe experimental intervention will have two components: (1) a caregiver parenting group, including all caregiver types (biological, foster, kinship), that meets weekly for 90-minutes for four months, focused on increasing parenting skills, and (2) a Life Coach component where trained and supported skills coaches meet individually with youth weekly for 60 minutes over the same four-month period to build the girls' social skills and peer/partner relationships skills. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- reside in Lane County and within 70 miles of the University of Oregon
- have a current caregiver
- both girl and caregiver are fluent in English
Key exclusion criteria (3 listed)
- are medically fragile
- have a significant developmental disability
- have graduated from high school or have a General Educational Diploma (GED)
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 |
|---|---|---|
| Parent Ed. and Youth Skills CoachingThe experimental intervention will have two components: (1) a caregiver parenting group, including all caregiver types (biological, foster, kinship), that meets weekly for 90-minutes for four months, focused on increasing parenting skills, and (2) a Life Coach component where trained and supported skills coaches meet individually with youth weekly for 60 minutes over the same four-month period to build the girls' social skills and peer/partner relationships skills. | Behavioural | Parent Ed. and Youth Skills Coaching |
| Services as UsualServices as usual as provided by community service organizations from which the sample was drawn. | Behavioural | Parent Ed. and Youth Skills Coaching, Services as Usual |
Primary outcome
Delinquency measured by official arrest records and standardized questionnaires
Time frame: Up to 12 months
Reduction in delinquent behaviors for teens participating in the intervention arm measured by official arrest records and standardized questionnaires, including the Youth Symptom inventory, the Elliott Self-report Delinquency Scale, the Achenbach System of Empirically Based Assessment, and the Parent Daily Report.
Sexual Risk Behavior
Time frame: Up to 12 months
Reduction in high risk sexual behaviors for teens participating in the intervention arm measured by standardized questionnaires, including Partner and Peer Behavior, Conflict in Adolescent Dating, Sexual Health Scale, and the Parent Daily Report.
2 secondary outcomes
Parenting measured by change in parenting practices for parents participating in the intervention arm measured by standardized questionnaires
Time frame: Up to 12 months
Substance Use
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Results publication: PubMed 31026258Horn SR, Leve LD, Levitt P, Fisher PA. Childhood adversity, mental health, and oxidative stress: A pilot study. PLoS One. 2019 Apr 26;14(4):e0215085. doi: 10.1371/journal.pone.0215085. eCollection 2019.
- Results publication: PubMed 30219076Clark M, Buchanan R, Kovensky R, Leve LD. Partner influences on young women's risky drug and sexual behavior. Reprod Health. 2018 Sep 15;15(1):156. doi: 10.1186/s12978-018-0598-0.
- Results publication: PubMed 29470424Clark M, Buchanan R, Leve LD. Young Women's Perspectives of Their Adolescent Treatment Programs: A Qualitative Study. Int J Environ Res Public Health. 2018 Feb 22;15(2):373. doi: 10.3390/ijerph15020373.
- Results publication: PubMed 32549929Kovensky R, Anderson D, Leve LD. Early Adversity and Sexual Risk in Adolescence: Externalizing Behaviors as a Mediator. J Child Adolesc Trauma. 2019 Aug 7;13(2):173-184. doi: 10.1007/s40653-019-00278-w. eCollection 2020 Jun.
- Individual participant dataSharing planned: Yes. Completely de-identified data shared. Interested investigators must secure IRB approval or waiver from their institution and cerfiy that they will not attempt to discern the identity of any participant.
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
Patti Chamberlain, PhD principal investigator
Oregon Social Learning Center
Rohanna Buchanan, PhD study director
Oregon Social Learning Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Ed. and Youth Skills Coaching and Services as Usual in people with Juvenile Delinquency Unspecified and Risk Behavior, run by University of Oregon 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 3 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 11 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 measured by official arrest records and standardized questionnaires (time frame: Up to 12 months). The study lists 2 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 NCT02420548, which also lists 4 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 11 May 2023.