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Adaptation and Evaluation of the KEEP Model

Primary Purpose

Depression, Anxiety, Post Traumatic Stress Disorder, Suicide and Self-harm

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KEEP
Non-Affinity KEEP
Sponsored by
Oregon Social Learning Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression, Anxiety

Eligibility Criteria

4 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Oregon Social Learning Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Affinity KEEP

Non-Affinity KEEP

Arm Description

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

Parents attending a Non-Affinity KEEP group.

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 17, 2022
Last Updated
April 17, 2023
Sponsor
Oregon Social Learning Center
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1. Study Identification

Unique Protocol Identification Number
NCT05816421
Brief Title
Adaptation and Evaluation of the KEEP Model
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Social Learning Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Post Traumatic Stress Disorder, Suicide and Self-harm, Externalizing Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Affinity KEEP
Arm Type
Experimental
Arm Description
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
Arm Title
Non-Affinity KEEP
Arm Type
Active Comparator
Arm Description
Parents attending a Non-Affinity KEEP group.
Intervention Type
Behavioral
Intervention Name(s)
KEEP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-Affinity KEEP
Intervention Description
Non-Affinity KEEP
Primary Outcome Measure Information:
Title
Mean change in youth depression and anxiety symptoms
Description
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.
Time Frame
Baseline and 6-months post-baseline
Title
Mean change in youth post traumatic stress disorder (PTSD) symptoms
Description
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.
Time Frame
Baseline and 6-months post-baseline
Title
Mean change in youth self harming behaviors and suicidal ideation
Description
Measured via parent report using the Child Behavior Checklist at baseline and 6-months post-baseline
Time Frame
Baseline and 6-months post-baseline
Title
Mean change in youth externalizing behaviors
Description
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.
Time Frame
Baseline and 6-months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey Tiberio, PhD
Organizational Affiliation
Oregon Social Learning Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rohanna Buchanan, PhD
Organizational Affiliation
Oregon Social Learning Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Social Learning Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
These data will be archived with NIMH Data Archive.
IPD Sharing URL
https://nda.nih.gov/edit_collection.html?id=4360

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Adaptation and Evaluation of the KEEP Model

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