- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05816421
Adaptation and Evaluation of the KEEP Model
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Oregon Social Learning Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Affinity KEEP
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:
|
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.
|
|
Active Comparator: Non-Affinity KEEP
Parents attending a Non-Affinity KEEP group.
|
Non-Affinity KEEP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
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
|
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.
|
Baseline and 6-months post-baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rohanna Buchanan, PhD, Oregon Social Learning Center
- Principal Investigator: Stacey Tiberio, PhD, Oregon Social Learning Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R56MH129490 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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