Depression, AnxietyNCT05816421
Adaptation and Evaluation of the KEEP Model
A study testing KEEP and Non-Affinity KEEP in people with Depression, Anxiety and Post Traumatic Stress Disorder, run by Oregon Social Learning Center at 1 site in United States.
Trial summary
This study capitalizes on an opportunity to formally evaluate local adaptations of "Keeping Foster and Kinship Parents Supported and Trained" (KEEP), an evidence-based foster parent intervention, to reduce mental health disparities among child welfare-involved youth and improve care quality and long-term outcomes for… Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Depression, Anxiety, Post Traumatic Stress Disorder, Suicide and Self-harm
- What is being tested?
- KEEP and Non-Affinity KEEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 30 Jan 2024
- 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 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Foster/resource parents who have been recruited to attend KEEP and have a focal youth for the intervention that:
- is a dependent of Child Welfare Services in the state of Oregon
- is between the ages of 4 and 21 years.
Who cannot join
- Foster/resource parents who have been recruited to attend KEEP and have a focal youth for the intervention that:
- is younger than 4 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reaching Optimal Implementation and Mental Health Outcomes for Underserved and Rural Communities in Foster and Kinship Care: Adaptation and Evaluation of the KEEP Model
This study capitalizes on an opportunity to formally evaluate local adaptations of "Keeping Foster and Kinship Parents Supported and Trained" (KEEP), an evidence-based foster parent intervention, to reduce mental health disparities among child welfare-involved youth and improve care quality and long-term outcomes for Native, Hispanic/Latino, Black/African American, and sexual and gender minority youth. The knowledge gained from the study will impact all current and future large-scale implementations of KEEP and will bolster our scientific understanding the impact of KEEP on youth mental health outcomes.
Read the detailed description
This study capitalizes on a contract with the Oregon Department of Human Services Child Welfare to implement KEEP state wide in Oregon with a focus on increasing access to services for minority youth populations. To help the child welfare system meet their goal of achieving health equity, adaptations to the KEEP curriculum have been made for minority groups, and KEEP is being delivered in "affinity groups". Affinity KEEP groups are tailored to meet a specific population's needs and are comprised of parents who all share a common interest, purpose, or key characteristic. To date, Affinity KEEP groups are being offered for foster/kin parents of populations defined by sexual and gender minority youth and Native youth, and for Spanish-speaking parents. The curriculum is currently being revised for transracial foster/kin placements where the youth and one or more parents are of a different race/ethnicity. The current proposal seeks to study N = 166 new families, as part of the ongoing Oregon KEEP implementation, and aggregate existing data from four KEEP studies to use propensity score matching to reduce selection bias and strengthen causal inferences that can be drawn from the potential benefits of providing KEEP to underserved minority populations. By leveraging two decades worth of data on the KEEP intervention and using state-of-the-art data harmonization techniques and a quasi-experimental design, this study affords a rigorous evaluation of whether tailoring the KEEP curriculum to minority populations' specific needs, and providing KEEP to foster/kin parents, improves youth mental health outcomes (i.e., depression/anxiety, post-traumatic stress disorder symptoms, suicidality, and externalizing behaviors) (Aim 1). The study could have a wide reach, impacting our understanding of how to improve and inform equitable delivery of services to youth and families involved in the child welfare system, and effectively address youth mental health disorders and improve care quality and long-term outcomes for a high-risk, underserved population of youth.
- Conditions
- Depression, Anxiety, Post Traumatic Stress Disorder, Suicide and Self-harm, Externalizing Behavior
- Being tested
- KEEP, Non-Affinity KEEP
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KEEPBehavioural
The KEEP model focuses on optimizing the role of foster/kin parents as the agents of positive change for children and youth. Parent KEEP groups for children (ages 4-12) and KEEP-Safe groups for teens (ages 13-19) are delivered by two co-group leaders for 16 weeks. Sessions are 90 minutes each week. The same group of 8-10 foster/kin parents attends each week. Each KEEP group follows a manualized curriculum that emphasizes tailoring the content to the unique needs of the parents and youth in the group. The key parenting principles of the model include: (a) reinforce normative and prosocial behavior, (b) incentivize the behavior that parents want to promote, (c) build cooperation, (d) teach new behaviors, (e) use non-harsh effective limit setting, and (f) manage emotions while parenting.
Non-Affinity KEEPBehavioural
Non-Affinity KEEP
| Study group | Role | What they receive |
|---|---|---|
| Affinity KEEP | Experimental | Affinity KEEP groups are tailored to meet a specific population's needs and are comprised of parents who all share a common interest, purpose, or key characteristic. The four types of Affinity KEEP groups for this study include:
* foster/kin parents of sexual and gender minority youth
* foster/kin parents of Native youth
* transracial placements where the youth and one or more parents are of a different race/ethnicity
* groups delivered in Spanish Receives: Behavioral: KEEP |
| Non-Affinity KEEP | Active comparator | Parents attending a Non-Affinity KEEP group. Receives: Behavioral: Non-Affinity KEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in youth depression and anxiety symptoms
Psychometric scoring techniques will be used to harmonize items across multiple KEEP studies and instruments. Specifically, moderated nonlinear factor analysis will be utilized to estimate depression and anxiety symptoms factor scores that account for differential item functioning and impact across the set of study- and person-level covariates. Youth depression and anxiety symptoms will be measured via parent report using items from the Child Behavior Checklist and Parent Daily Report at baseline and 6-months post-baseline.
Measured: Baseline and 6-months post-baseline
Mean change in youth post traumatic stress disorder (PTSD) symptoms
Psychometric scoring techniques will be used to harmonize items across multiple KEEP studies and instruments. Specifically, moderated nonlinear factor analysis will be utilized to estimate PTSD symptoms factor scores that account for differential item functioning and impact across the set of study- and person-level covariates. Youth PTSD symptoms will be measured via parent report using items from the Child Behavior Checklist and Parent Daily Report at baseline and 6-months post-baseline.
Measured: Baseline and 6-months post-baseline
Mean change in youth self harming behaviors and suicidal ideation
Measured via parent report using the Child Behavior Checklist at baseline and 6-months post-baseline
Measured: Baseline and 6-months post-baseline
Mean change in youth externalizing behaviors
Psychometric scoring techniques will be used to harmonize items across multiple KEEP studies and instruments. Specifically, moderated nonlinear factor analysis will be utilized to estimate externalizing behavior factor scores that account for differential item functioning and impact across the set of study- and person-level covariates. Youth externalizing behaviors will be measured via parent report using items from the Child Behavior Checklist and Parent Daily Report at baseline and 6-months post-baseline.
Measured: Baseline and 6-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start16 May 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Social Learning Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacey Tiberio, Oregon Social Learning Center
- Investigators
- Stacey Tiberio, PhD, Principal investigator, Oregon Social Learning CenterRohanna Buchanan, PhD, Principal investigator, Oregon Social Learning Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816421
- Sponsor's protocol ID
- R56MH129490
- Status last verified
- Aug 2025
- First submitted
- 17 Nov 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: These data will be archived with NIMH Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Optimal Implementation and Mental Health Outcomes for Underserved and Rural Communities in Foster and Kinship Care: Adaptation and Evaluation of the KEEP Model
- ClinicalTrials.gov ID
- NCT05816421
- Acronym / sponsor ID
- R56MH129490
- Conditions
- Depression, Anxiety, Post Traumatic Stress Disorder, Suicide and Self-harm, Externalizing Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- 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.
This study capitalizes on an opportunity to formally evaluate local adaptations of "Keeping Foster and Kinship Parents Supported and Trained" (KEEP), an evidence-based foster parent intervention, to reduce mental health disparities among child welfare-involved youth and improve care quality and long-term outcomes for Native, Hispanic/Latino, Black/African American, and sexual and gender minority youth. The knowledge gained from the study will impact all current and future large-scale implementations of KEEP and will bolster our scientific understanding the impact of KEEP on youth mental health outcomes.
Detailed description
This study capitalizes on a contract with the Oregon Department of Human Services Child Welfare to implement KEEP state wide in Oregon with a focus on increasing access to services for minority youth populations. To help the child welfare system meet their goal of achieving health equity, adaptations to the KEEP curriculum have been made for minority groups, and KEEP is being delivered in "affinity groups". Affinity KEEP groups are tailored to meet a specific population's needs and are comprised of parents who all share a common interest, purpose, or key characteristic. To date, Affinity KEEP groups are being offered for foster/kin parents of populations defined by sexual and gender minority youth and Native youth, and for Spanish-speaking parents. The curriculum is currently being revised for transracial foster/kin placements where the youth and one or more parents are of a different race/ethnicity. The current proposal seeks to study N = 166 new families, as part of the ongoing Oregon KEEP implementation, and aggregate existing data from four KEEP studies to use propensity score matching to reduce selection bias and strengthen causal inferences that can be drawn from the potential benefits of providing KEEP to underserved minority populations. By leveraging two decades worth of data on the KEEP intervention and using state-of-the-art data harmonization techniques and a quasi-experimental design, this study affords a rigorous evaluation of whether tailoring the KEEP curriculum to minority populations' specific needs, and providing KEEP to foster/kin parents, improves youth mental health outcomes (i.e., depression/anxiety, post-traumatic stress disorder symptoms, suicidality, and externalizing behaviors) (Aim 1). The study could have a wide reach, impacting our understanding of how to improve and inform equitable delivery of services to youth and families involved in the child welfare system, and effectively address youth mental health disorders and improve care quality and long-term outcomes for a high-risk, underserved population of youth.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affinity KEEP | Experimental | Behavioral: KEEPAffinity KEEP groups are tailored to meet a specific population's needs and are comprised of parents who all share a common interest, purpose, or key characteristic. The four types of Affinity KEEP groups for this study include: * foster/kin parents of sexual and gender minority youth * foster/kin parents of Native youth * transracial placements where the youth and one or more parents are of a different race/ethnicity * groups delivered in Spanish |
| Non-Affinity KEEP | Active comparator | Behavioral: Non-Affinity KEEPParents attending a Non-Affinity KEEP group. |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Foster/resource parents who have been recruited to attend KEEP and have a focal youth for the intervention that:
- is a dependent of Child Welfare Services in the state of Oregon
- is between the ages of 4 and 21 years.
Key exclusion criteria (2 listed)
- Foster/resource parents who have been recruited to attend KEEP and have a focal youth for the intervention that:
- is younger than 4 years of age.
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 |
|---|---|---|
| KEEPThe KEEP model focuses on optimizing the role of foster/kin parents as the agents of positive change for children and youth. Parent KEEP groups for children (ages 4-12) and KEEP-Safe groups for teens (ages 13-19) are delivered by two co-group leaders for 16 weeks. Sessions are 90 minutes each week. The same group of 8-10 foster/kin parents attends each week. Each KEEP group follows a manualized curriculum that emphasizes tailoring the content to the unique needs of the parents and youth in the group. The key parenting principles of the model include: (a) reinforce normative and prosocial behavior, (b) incentivize the behavior that parents want to promote, (c) build cooperation, (d) teach new behaviors, (e) use non-harsh effective limit setting, and (f) manage emotions while parenting. | Behavioural | Affinity KEEP |
| Non-Affinity KEEPNon-Affinity KEEP | Behavioural | Non-Affinity KEEP |
Primary outcome
Mean change in youth depression and anxiety symptoms
Time frame: Baseline and 6-months post-baseline
Psychometric scoring techniques will be used to harmonize items across multiple KEEP studies and instruments. Specifically, moderated nonlinear factor analysis will be utilized to estimate depression and anxiety symptoms factor scores that account for differential item functioning and impact across the set of study- and person-level covariates. Youth depression and anxiety symptoms will be measured via parent report using items from the Child Behavior Checklist and Parent Daily Report at baseline and 6-months post-baseline.
Mean change in youth post traumatic stress disorder (PTSD) symptoms
Time frame: Baseline and 6-months post-baseline
Psychometric scoring techniques will be used to harmonize items across multiple KEEP studies and instruments. Specifically, moderated nonlinear factor analysis will be utilized to estimate PTSD symptoms factor scores that account for differential item functioning and impact across the set of study- and person-level covariates. Youth PTSD symptoms will be measured via parent report using items from the Child Behavior Checklist and Parent Daily Report at baseline and 6-months post-baseline.
Mean change in youth self harming behaviors and suicidal ideation
Time frame: Baseline and 6-months post-baseline
Measured via parent report using the Child Behavior Checklist at baseline and 6-months post-baseline
Mean change in youth externalizing behaviors
Time frame: Baseline and 6-months post-baseline
Psychometric scoring techniques will be used to harmonize items across multiple KEEP studies and instruments. Specifically, moderated nonlinear factor analysis will be utilized to estimate externalizing behavior factor scores that account for differential item functioning and impact across the set of study- and person-level covariates. Youth externalizing behaviors will be measured via parent report using items from the Child Behavior Checklist and Parent Daily Report at baseline and 6-months post-baseline.
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 5 Sep 2025.
- Individual participant dataSharing planned: Yes. These data will be archived with NIMH Data Archive.
Related trials for Depression, Anxiety
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Not yet recruiting
Health-Related Social Needs Food Boxes Delivery Program
Food Insecurity
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.
Stacey Tiberio, PhD principal investigator
Oregon Social Learning Center
Rohanna Buchanan, PhD principal investigator
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 KEEP and Non-Affinity KEEP in people with Depression, Anxiety and Post Traumatic Stress Disorder, 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 3 inclusion and 2 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 5 Sep 2025. 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?
Mean change in youth depression and anxiety symptoms (time frame: Baseline and 6-months post-baseline). The study lists 4 primary outcomes in all. 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 5 Sep 2025.