Internalizing BehaviorKEEP-CKNCT06294392
KEEP Connecting Kin
A study testing KEEP-CK in people with Internalizing Behavior and Externalizing Behavior, run by Oregon Social Learning Center at 1 site in United States.
Trial summary
The current study provides a unique opportunity to conduct a summative evaluation of the KEEP Connecting Kin (KEEP-CK) program by leveraging extant relationships with Oregon's Child Welfare System (CWS), Self-Sufficiency Program (SSP), and our community partners to address the needs of informal kinship families and… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Internalizing Behavior, Externalizing Behavior, Child Permanency
- What is being tested?
- KEEP-CK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informal kinship caregivers in Oregon are defined as relatives or fictive kin who are caring for children between the ages of 4 to 18 years outside of the child welfare system with no birth/step parent living in the home.
Who cannot join
- Informal kinship caregivers in Oregon who have previously participated in a KEEP or KEEP-CK group, or have a partner living in their home who has previously participated in a KEEP or KEEP-CK group.
- Focal child is not between the ages of 4-18 years at the baseline assessment.
- Focal child has been adopted by the kinship parent at the baseline assessment.
- Focal child is not living with the kinship caregiver full time (e.g., babysitting/weekends/vacations) at the baseline assessment.
- Focal child is in child welfare at the baseline assessment.
- Focal child is living with the kinship caregiver in a certified foster home at the baseline assessment.
- Focal child has a developmental disability or delay that impairs their ability to be responsive to the parenting content of KEEP-CK.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KEEP Connecting Kin: Improving Outcomes for Informal Kinship Care Families Via an In-Home Parenting and Peer-Support Program
The current study provides a unique opportunity to conduct a summative evaluation of the KEEP Connecting Kin (KEEP-CK) program by leveraging extant relationships with Oregon's Child Welfare System (CWS), Self-Sufficiency Program (SSP), and our community partners to address the needs of informal kinship families and the youth in their care. Specifically, a randomized "services-as-usual" (SAU) waitlist control design plus qualitative methods will be used to evaluate the immediate (post-intervention) and sustained (10 month) impacts of the KEEP-CK program on child, adult, and service utilization outcomes, and prevention of entry into the CWS.
Read the detailed description
In the 2022 Oregon census, it was estimated that for every child placed in kinship foster care, there are 14 children being raised by kin outside of the child welfare system (CWS), with ~37,000 children being raised by kin and ~17,000 of those by grandparents. Kin caregivers, in particular those who are informal or voluntary, have fewer supports compared to non-relative (foster) caregivers and kin caregivers who are licensed by the CWS. Kin families are far less likely to access and utilize services in multiple systems. Thus, there is a great need to provide kin families with resources and keep youth who are living in kinship care out of the CWS.
"Keeping Parents Supported and Trained" (KEEP) was initially developed to focus on foster and kinship families involved in the CWS. In three prior NIH-funded randomized controlled trials, KEEP has shown positive impacts on youth and parent outcomes, and placement stability. KEEP has been scaled-up statewide in Oregon for CWS-involved families. The current study will focus on informal kinship care, thereby adding to an emerging body of evidence on the benefits of providing enhanced parenting and peer support to families by scaling-out the KEEP program to serve kin families outside of the CWS. This research builds on an initial study, "KEEP Connecting Kin" (KEEP-CK), where KEEP was adapted for informal kin, currently underway with participant recruitment ending in October 2023.
The proposed study (KEEP-CK#2) leverages our on-going relationships with state leadership in the CWS and SSP, and our community partners delivering KEEP-CK in Study #1 statewide in Oregon. In Study #2, a randomized "services-as-usual" (SAU) waitlist control design plus qualitative methods will be used to conduct a summative evaluation of the KEEP-CK program by recruiting N = 192 kinship families to examine the immediate (post-intervention) and sustained (10 month) impacts of the program on child, adult, and service utilization outcomes and prevention of entry into the CWS. Research questions include:
Aim 1 (impact on child and adult outcomes): The KEEP-CK program is posited to improve child and adult outcomes at the end of the intervention, and such effects are posited to be sustained at 6 months after the end of the intervention (10 months post baseline), compared to those who received SAU. Targeted child outcomes include (a) child well-being (i.e., behavioral and emotional functioning, including child internalizing and externalizing behaviors) and (b) child permanency (i.e., placement stability and permanency of placements). Targeted adult outcomes include (c) parenting practices and (d) parent/caregiver stress.
Aim 2 (impact on use of services): The KEEP-CK program is posited to increase parents' access to and use of services from multiple systems (e.g., Oregon Kinship Navigator, financial, educational, mental health, medical, legal) at post-intervention and follow-up compared to those who received SAU.
Aim 3 (impact on prevention of entry into the CWS): The KEEP-CK program is posited to reduce the likelihood that youth who are living in kinship care enter into the CWS by the 10-month follow-up assessment, compared to youth whose kinship caregivers received SAU.
Aim 4 (parent and youth perspectives): Qualitative methods will be used to evaluate families' satisfaction with and perspectives on the impact of KEEP-CK on child and adult outcomes.
- Conditions
- Internalizing Behavior, Externalizing Behavior, Child Permanency, Parenting, Parent Stress, Service Utilization
- Being tested
- KEEP-CK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KEEP-CKBehavioural
The KEEP-CK model focuses on optimizing the role of kinship parents as the agents of positive change for children and youth. KEEP-CK groups for kinship parents are delivered by two co-group leaders for 16 weeks. Sessions are 90 minutes each week. The same group of 8-12 kinship parents attends each week. Each KEEP-CK group follows a manualized curriculum that emphasizes tailoring the content to the unique needs and cultures of the parent in the group and the youth in their care. 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. The key services connection elements of the model include: (a) parent discussions of services they are using or have used and (b) KEEP-CK group leaders share examples from a list of statewide and national services.
| Study group | Role | What they receive |
|---|---|---|
| KEEP-CK | Experimental | Participants who are randomly assigned to the KEEP-CK condition will participate in 16 weekly group sessions with 8-12 other informal kinship caregivers, and receive manualized content related to positive parenting skills, and peer-to-peer supports and recommendations for services. Receives: Behavioral: KEEP-CK |
| "Services as usual" (SAU) waitlist control | No intervention | Participants who are randomly assigned to the "services as usual" (SAU) waitlist control condition will be eligible to receive SAU that are available to all informal kinship caregivers in Oregon. Participants who ask about receiving supports will be referred to the Oregon Kinship Navigator, which is a statewide kinship navigator program that is available to all informal kinship caregivers in Oregon regardless of their participation in this study. Participants in the SAU waitlist control condition will be offered the opportunity to participate in a KEEP-CK group after 10 months, with these participants only contribute data to the SAU control condition for the impact analyses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in youth well-being (i.e., behavioral and emotional functioning, including child internalizing and externalizing behaviors)
Youth well-being will be measured via kinship parent report using the Child Behavior Checklist (CBCL) at baseline and 4- and 10-months post-baseline. The CBCL has eight subscales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior [delinquency], and aggressive behavior), which make up three broadband scales: total behavior, internalizing, and externalizing problems.
Measured: Baseline, and 4- and 10-months post-baseline
Mean change in child permanency (i.e., placement stability and permanency of placements)
All children will be living in informal kinship care at the time of the baseline assessment. Changes in the child's placement setting (living conditions) will be measured via kinship parent report using the Change of Placement questionnaire at 4- and 10-months post-baseline.
Measured: Baseline, and 4- and 10-months post-baseline
Mean change in parenting practices and parent/caregiver stress.
Parenting practices and parent/caregiver stress will be measured via the Parent Daily Report (PDR) at baseline and 4- and 10-months post-baseline. The PDR assesses whether the parent found any of the focal child's internalizing and externalizing behaviors to be stressful, and the types of positive reinforcement and discipline that were used with the child.
Measured: Baseline, and 4- and 10-months post-baseline
Mean change in parent/caregiver stress.
Parent/caregiver stress will be measured via a shortened version of the Parenting Stress Index (PSI) short form at baseline and 4- and 10-months post-baseline to assess two domains, including parental distress, and parent-child dysfunctional interaction.
Measured: Baseline, and 4- and 10-months post-baseline
Mean change in parenting practices.
Parenting practices will be measured via the Alabama Parenting Questionnaire (APQ) short form at baseline and 4- and 10-months post-baseline. The APQ short form assesses positive parenting, and the types of, and consistency with which, discipline was used with the focal child.
Measured: Baseline, and 4- and 10-months post-baseline
Mean change in parents' use of services from multiple systems (financial, educational, mental health, medical, legal)
Parents will complete the Service Utilization Survey (SUS) at baseline and 4- and 10-months post-baseline, which is a measure of need for, and use of, health care and social services. Parents report on services that they have sought and used for themselves or the focus child over a 4- to 6-month period. The types of services include: housing, legal matters, financial, parenting support, medical, counseling/mental health, education, extracurricular activities, and social support from friends/relatives.
Measured: Baseline, and 4- and 10-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 posted5 Mar 2024
- Study start13 Feb 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internalizing BehaviorStudies 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
- Model description
- Informal kinship caregivers will be randomly assigned to receive the KEEP-CK program either immediately or after waiting 10 months using a randomized blocked design. Blocking factors include: (a) the length of time that the child has been living in informal kinship care (\<=6 months, 7 months to \<2 years, or \>=2 years); (b) child age (4 to 12 years, or 13+ years); and (c) low (or not low) resource families, defined by an annual household income below (or above) 150% of the federal poverty level.
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Social Learning Center
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Planning, Research & Evaluation
- Responsible party
- Principal investigator, Stacey Tiberio, Oregon Social Learning Center
- Investigators
- Stacey Tiberio, Ph.D., Principal investigator, Oregon Social Learning Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294392
- Sponsor's protocol ID
- 90FA3010
- Acronym
- KEEP-CK
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KEEP Connecting Kin: Improving Outcomes for Informal Kinship Care Families Via an In-Home Parenting and Peer-Support Program
- ClinicalTrials.gov ID
- NCT06294392
- Acronym / sponsor ID
- KEEP-CK / 90FA3010
- Conditions
- Internalizing Behavior, Externalizing Behavior, Child Permanency, Parenting, Parent Stress, Service Utilization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Collaborators
- Office of Planning, Research & Evaluation
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 Mar 2024 (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.
The current study provides a unique opportunity to conduct a summative evaluation of the KEEP Connecting Kin (KEEP-CK) program by leveraging extant relationships with Oregon's Child Welfare System (CWS), Self-Sufficiency Program (SSP), and our community partners to address the needs of informal kinship families and the youth in their care. Specifically, a randomized "services-as-usual" (SAU) waitlist control design plus qualitative methods will be used to evaluate the immediate (post-intervention) and sustained (10 month) impacts of the KEEP-CK program on child, adult, and service utilization outcomes, and prevention of entry into the CWS.
Detailed description
In the 2022 Oregon census, it was estimated that for every child placed in kinship foster care, there are 14 children being raised by kin outside of the child welfare system (CWS), with ~37,000 children being raised by kin and ~17,000 of those by grandparents. Kin caregivers, in particular those who are informal or voluntary, have fewer supports compared to non-relative (foster) caregivers and kin caregivers who are licensed by the CWS. Kin families are far less likely to access and utilize services in multiple systems. Thus, there is a great need to provide kin families with resources and keep youth who are living in kinship care out of the CWS.
"Keeping Parents Supported and Trained" (KEEP) was initially developed to focus on foster and kinship families involved in the CWS. In three prior NIH-funded randomized controlled trials, KEEP has shown positive impacts on youth and parent outcomes, and placement stability. KEEP has been scaled-up statewide in Oregon for CWS-involved families. The current study will focus on informal kinship care, thereby adding to an emerging body of evidence on the benefits of providing enhanced parenting and peer support to families by scaling-out the KEEP program to serve kin families outside of the CWS. This research builds on an initial study, "KEEP Connecting Kin" (KEEP-CK), where KEEP was adapted for informal kin, currently underway with participant recruitment ending in October 2023.
The proposed study (KEEP-CK#2) leverages our on-going relationships with state leadership in the CWS and SSP, and our community partners delivering KEEP-CK in Study #1 statewide in Oregon. In Study #2, a randomized "services-as-usual" (SAU) waitlist control design plus qualitative methods will be used to conduct a summative evaluation of the KEEP-CK program by recruiting N = 192 kinship families to examine the immediate (post-intervention) and sustained (10 month) impacts of the program on child, adult, and service utilization outcomes and prevention of entry into the CWS. Research questions include:
Aim 1 (impact on child and adult outcomes): The KEEP-CK program is posited to improve child and adult outcomes at the end of the intervention, and such effects are posited to be sustained at 6 months after the end of the intervention (10 months post baseline), compared to those who received SAU. Targeted child outcomes include (a) child well-being (i.e., behavioral and emotional functioning, including child internalizing and externalizing behaviors) and (b) child permanency (i.e., placement stability and permanency of placements). Targeted adult outcomes include (c) parenting practices and (d) parent/caregiver stress.
Aim 2 (impact on use of services): The KEEP-CK program is posited to increase parents' access to and use of services from multiple systems (e.g., Oregon Kinship Navigator, financial, educational, mental health, medical, legal) at post-intervention and follow-up compared to those who received SAU.
Aim 3 (impact on prevention of entry into the CWS): The KEEP-CK program is posited to reduce the likelihood that youth who are living in kinship care enter into the CWS by the 10-month follow-up assessment, compared to youth whose kinship caregivers received SAU.
Aim 4 (parent and youth perspectives): Qualitative methods will be used to evaluate families' satisfaction with and perspectives on the impact of KEEP-CK on child and adult outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Informal kinship caregivers will be randomly assigned to receive the KEEP-CK program either immediately or after waiting 10 months using a randomized blocked design. Blocking factors include: (a) the length of time that the child has been living in informal kinship care (<=6 months, 7 months to <2 years, or >=2 years); (b) child age (4 to 12 years, or 13+ years); and (c) low (or not low) resource families, defined by an annual household income below (or above) 150% of the federal poverty level.
| Arm | Type | Receives |
|---|---|---|
| KEEP-CK | Experimental | Behavioral: KEEP-CKParticipants who are randomly assigned to the KEEP-CK condition will participate in 16 weekly group sessions with 8-12 other informal kinship caregivers, and receive manualized content related to positive parenting skills, and peer-to-peer supports and recommendations for services. |
| "Services as usual" (SAU) waitlist control | No intervention | –Participants who are randomly assigned to the "services as usual" (SAU) waitlist control condition will be eligible to receive SAU that are available to all informal kinship caregivers in Oregon. Participants who ask about receiving supports will be referred to the Oregon Kinship Navigator, which is a statewide kinship navigator program that is available to all informal kinship caregivers in Oregon regardless of their participation in this study. Participants in the SAU waitlist control condition will be offered the opportunity to participate in a KEEP-CK group after 10 months, with these participants only contribute data to the SAU control condition for the impact analyses. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Informal kinship caregivers in Oregon are defined as relatives or fictive kin who are caring for children between the ages of 4 to 18 years outside of the child welfare system with no birth/step parent living in the home.
Key exclusion criteria (7 listed)
- Informal kinship caregivers in Oregon who have previously participated in a KEEP or KEEP-CK group, or have a partner living in their home who has previously participated in a KEEP or KEEP-CK group.
- Focal child is not between the ages of 4-18 years at the baseline assessment.
- Focal child has been adopted by the kinship parent at the baseline assessment.
- Focal child is not living with the kinship caregiver full time (e.g., babysitting/weekends/vacations) at the baseline assessment.
- Focal child is in child welfare at the baseline assessment.
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 |
|---|---|---|
| KEEP-CKThe KEEP-CK model focuses on optimizing the role of kinship parents as the agents of positive change for children and youth. KEEP-CK groups for kinship parents are delivered by two co-group leaders for 16 weeks. Sessions are 90 minutes each week. The same group of 8-12 kinship parents attends each week. Each KEEP-CK group follows a manualized curriculum that emphasizes tailoring the content to the unique needs and cultures of the parent in the group and the youth in their care. 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. The key services connection elements of the model include: (a) parent discussions of services they are using or have used and (b) KEEP-CK group leaders share examples from a list of statewide and national services. | Behavioural | KEEP-CK |
Primary outcome
Mean change in youth well-being (i.e., behavioral and emotional functioning, including child internalizing and externalizing behaviors)
Time frame: Baseline, and 4- and 10-months post-baseline
Youth well-being will be measured via kinship parent report using the Child Behavior Checklist (CBCL) at baseline and 4- and 10-months post-baseline. The CBCL has eight subscales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior [delinquency], and aggressive behavior), which make up three broadband scales: total behavior, internalizing, and externalizing problems.
Mean change in child permanency (i.e., placement stability and permanency of placements)
Time frame: Baseline, and 4- and 10-months post-baseline
All children will be living in informal kinship care at the time of the baseline assessment. Changes in the child's placement setting (living conditions) will be measured via kinship parent report using the Change of Placement questionnaire at 4- and 10-months post-baseline.
Mean change in parenting practices and parent/caregiver stress.
Time frame: Baseline, and 4- and 10-months post-baseline
Parenting practices and parent/caregiver stress will be measured via the Parent Daily Report (PDR) at baseline and 4- and 10-months post-baseline. The PDR assesses whether the parent found any of the focal child's internalizing and externalizing behaviors to be stressful, and the types of positive reinforcement and discipline that were used with the child.
Mean change in parent/caregiver stress.
Time frame: Baseline, and 4- and 10-months post-baseline
Parent/caregiver stress will be measured via a shortened version of the Parenting Stress Index (PSI) short form at baseline and 4- and 10-months post-baseline to assess two domains, including parental distress, and parent-child dysfunctional interaction.
Mean change in parenting practices.
Time frame: Baseline, and 4- and 10-months post-baseline
Parenting practices will be measured via the Alabama Parenting Questionnaire (APQ) short form at baseline and 4- and 10-months post-baseline. The APQ short form assesses positive parenting, and the types of, and consistency with which, discipline was used with the focal child.
Mean change in parents' use of services from multiple systems (financial, educational, mental health, medical, legal)
Time frame: Baseline, and 4- and 10-months post-baseline
Parents will complete the Service Utilization Survey (SUS) at baseline and 4- and 10-months post-baseline, which is a measure of need for, and use of, health care and social services. Parents report on services that they have sought and used for themselves or the focus child over a 4- to 6-month period. The types of services include: housing, legal matters, financial, parenting support, medical, counseling/mental health, education, extracurricular activities, and social support from friends/relatives.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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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, Ph.D. 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-CK in people with Internalizing Behavior and Externalizing Behavior, 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 1 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 22 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?
This study is still under way. Results are not available in the source record yet.
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 well-being (i.e., behavioral and emotional functioning, including child internalizing and externalizing behaviors) (time frame: Baseline, and 4- and 10-months post-baseline). The study lists 6 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 22 Sep 2025.