School AdjustmentLINKSNCT02037750
Foster Teens' Risk During Transition
A study testing LINKS in people with School Adjustment and Foster Care Disruptions, run by Oregon Social Learning Center at 2 sites in United States.
Trial summary
The purpose of this study is to conduct a randomized effectiveness trial to determine whether adding a preventive intervention at the transition from elementary to middle school is effective and cost effective in terms of ameliorating outcomes such as drug and tobacco use, participation in HIV- risking sexual… Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- School Adjustment, Foster Care Disruptions
- What is being tested?
- LINKS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to 1 Jun 2018
- 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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- the focal youth will be transitioning into middle school
- the focal youth is in either a foster or kinship care home
- the focal youth has been in the home for a minimum of 30 days (including those who are newly placed in care and those moving from another type of placement).
Who cannot join
- youth who are are considered medically fragile (i.e., severely physically or mentally handicapped)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Social Learning Center
Eugene, Oregon, 97401
San Diego State University Foundation
San Diego, California, 92182-1948
About this study
Official title: Foster Teens' Risk During Transition: Preventing Drug Use, HIV, & School Problems
The purpose of this study is to conduct a randomized effectiveness trial to determine whether adding a preventive intervention at the transition from elementary to middle school is effective and cost effective in terms of ameliorating outcomes such as drug and tobacco use, participation in HIV- risking sexual behavior, delinquency, mental health problems, and school failure for young adolescents in foster care. The proposed LINKS intervention marries the goals of child welfare and educational systems. The aims are: a) to determine the effectiveness of the LINKS intervention on key behavioral health and school adjustment outcomes, b) to examine mechanisms of action; specifically the mediating effects of placement failure on outcomes, c) to examine the moderating role of fidelity on outcomes, and d) to examine cost effectiveness and cost avoidance of LINKS.
- Conditions
- School Adjustment, Foster Care Disruptions
- Being tested
- LINKS
- Keywords
- foster care, school adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINKSBehavioural
In the LINKS, foster/kin parents will participate in weekly group meetings led by well-trained and supervised paraprofessional facilitators (school behavioral aids and foster parents) where the curriculum is based on parent management training (PMT). In previous studies, attendance at such groups has been high, averaging about 75-80%. Missed sessions will be "made up" with an in-person visit to the foster/kin home during the week of the original session. In addition, youth in the intervention condition will receive individual skill building sessions from a Life Skills Coach to increase their competency at goal setting, refusal skills, and peer relations.
| Study group | Role | What they receive |
|---|---|---|
| LINKS | Experimental | Foster parent and child participate in 16-week intervention Receives: Behavioral: LINKS |
| Services as Usual | No intervention | Foster parent and child receive standard services through child welfare system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Placement Failures
Measured: between Baseline and 18-Months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startDec 2012
- Primary completionJun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School AdjustmentStudies 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
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Social Learning Center
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University
- Responsible party
- Sponsor
- Investigators
- Patricia Chamberlain, Phd, Principal investigator, Oregon Social Learning Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037750
- Sponsor's protocol ID
- R01DA032634
- Acronym
- LINKS
- Status last verified
- Nov 2018
- First submitted
- 13 Jan 2014
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foster Teens' Risk During Transition: Preventing Drug Use, HIV, & School Problems
- ClinicalTrials.gov ID
- NCT02037750
- Acronym / sponsor ID
- LINKS / R01DA032634
- Conditions
- School Adjustment, Foster Care Disruptions
- Keywords
- foster care, school adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Collaborators
- San Diego State University
- Study start
- Dec 2012
- Primary completion
- Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 16 Jan 2014 (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 purpose of this study is to conduct a randomized effectiveness trial to determine whether adding a preventive intervention at the transition from elementary to middle school is effective and cost effective in terms of ameliorating outcomes such as drug and tobacco use, participation in HIV- risking sexual behavior, delinquency, mental health problems, and school failure for young adolescents in foster care. The proposed LINKS intervention marries the goals of child welfare and educational systems. The aims are: a) to determine the effectiveness of the LINKS intervention on key behavioral health and school adjustment outcomes, b) to examine mechanisms of action; specifically the mediating effects of placement failure on outcomes, c) to examine the moderating role of fidelity on outcomes, and d) to examine cost effectiveness and cost avoidance of LINKS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LINKS | Experimental | Behavioral: LINKSFoster parent and child participate in 16-week intervention |
| Services as Usual | No intervention | –Foster parent and child receive standard services through child welfare system |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- the focal youth will be transitioning into middle school
- the focal youth is in either a foster or kinship care home
- the focal youth has been in the home for a minimum of 30 days (including those who are newly placed in care and those moving from another type of placement).
Key exclusion criteria (1 listed)
- youth who are are considered medically fragile (i.e., severely physically or mentally handicapped)
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 |
|---|---|---|
| LINKSIn the LINKS, foster/kin parents will participate in weekly group meetings led by well-trained and supervised paraprofessional facilitators (school behavioral aids and foster parents) where the curriculum is based on parent management training (PMT). In previous studies, attendance at such groups has been high, averaging about 75-80%. Missed sessions will be "made up" with an in-person visit to the foster/kin home during the week of the original session. In addition, youth in the intervention condition will receive individual skill building sessions from a Life Skills Coach to increase their competency at goal setting, refusal skills, and peer relations. | Behavioural | LINKS |
Primary outcome
Number of Placement Failures
Time frame: between Baseline and 18-Months later
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 23 Nov 2018.
Related trials for School Adjustment
Not yet recruiting
Effectiveness of a Psychological Resilience Training Program for Children Aged 10-12
Psychological Resilience, Social Adjustment
Active, not recruiting
The Families and Middle School Success Project
Parenting, Parent-Child Relations
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.
Patricia Chamberlain, Phd principal investigator
Oregon Social Learning Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LINKS in people with School Adjustment and Foster Care Disruptions, run by Oregon Social Learning Center at 2 sites 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 1 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 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of Placement Failures (time frame: between Baseline and 18-Months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2018.