KEEP-CK Program for Parenting Stress

(KEEP-CK Trial)

Overseen By Stacey Tiberio, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Social Learning Center

Disqualifiers: Previous KEEP participation, Adoption, Child welfare, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 18

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the KEEP-CK program, which supports informal kinship caregivers by teaching positive parenting skills and offering peer support. The study will compare this program to the usual services caregivers receive to assess its impact on family well-being and service use. Participants will join either the KEEP-CK group or a waitlist for usual services. Eligible participants are informal kinship caregivers in Oregon raising children aged 4 to 18 without the children's birth or step-parents living in the home. As an unphased trial, this study provides a unique opportunity for caregivers to gain valuable skills and support that can enhance family dynamics.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the KEEP-CK program is safe for participants?

Research has shown that the KEEP Connecting Kin (KEEP-CK) program is safe for participants. KEEP-CK includes weekly group sessions that focus on positive parenting and peer support. Previous studies with similar programs have reported no harmful effects. The program aims to help families and children by improving parenting skills and offering community support. These types of programs are generally well-received, with no known risks to participants. Overall, KEEP-CK supports families without causing any safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The KEEP-CK program is unique because it targets parenting stress specifically for informal kinship caregivers, a group that often doesn't receive tailored support. Unlike traditional approaches that might offer general parenting advice or refer caregivers to existing services, KEEP-CK provides a structured, supportive environment with 16 weekly group sessions. These sessions focus on positive parenting skills and peer-to-peer support, creating a community of shared experiences and mutual guidance. Researchers are excited about KEEP-CK because it not only addresses parenting techniques but also builds a support network, potentially leading to more sustainable, long-term improvements in caregiver well-being.

What evidence suggests that the KEEP-CK program is effective for reducing parenting stress?

Research has shown that the KEEP-CK program, which participants in this trial may receive, helps families where relatives, such as grandparents or aunts and uncles, are raising children. Studies have found that KEEP-CK can reduce stress for these caregivers and enhance their parenting skills. These improvements often lead to better behavior and emotions in children, such as fewer behavioral issues. The program is also associated with fewer disruptions in the child's living situation, helping them remain in stable homes. This evidence suggests that KEEP-CK can be a valuable support for families facing the challenges of informal kinship care. ^{1 2 4 6 7}

Who Is on the Research Team?

Stacey Tiberio, Ph.D.

Principal Investigator

Oregon Social Learning Center

Are You a Good Fit for This Trial?

This trial is for informal kinship families and youth under their care, who are involved with Oregon's Child Welfare System or Self-Sufficiency Program. It aims to help those experiencing depression, parenting stress, or dealing with children's externalizing behavior.

Inclusion Criteria

I am caring for a child aged 4-18 in Oregon without their parents.

Exclusion Criteria

Focal child has been adopted by the kinship parent at the baseline assessment

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 living with the kinship caregiver in a certified foster home at the baseline assessment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the KEEP-CK condition will participate in 16 weekly group sessions with 8-12 other informal kinship caregivers, receiving manualized content related to positive parenting skills and peer-to-peer supports.

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for sustained impacts on child, adult, and service utilization outcomes, and prevention of entry into the CWS.

10 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• KEEP-CK

Trial Overview The KEEP-CK program is being tested against standard services (services-as-usual). Participants will be randomly assigned to either receive the KEEP-CK intervention immediately or placed on a waitlist. The study measures the program’s effects right after it ends and again at 10 months.

How Is the Trial Designed?

Group I: KEEP-CK Experimental Treatment 1 Intervention

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.

Group II: "Services as usual" (SAU) waitlist control Active Control 1 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.

KEEP-CK is already approved in United States for the following indications:

Approved in United States as KEEP Connecting Kin for:

• Support for kinship caregivers
• Prevention of entry into the child welfare system
• Improvement of child and adult outcomes

Who Is Running the Clinical Trial?

Oregon Social Learning Center

Lead Sponsor

Trials

36

Recruited

8,900+

Office of Planning, Research & Evaluation

Collaborator

Trials

17

Recruited

222,000+

Published Research Related to This Trial

Project SafeCare, an in-home intervention program for parents reported for child abuse and neglect, effectively reduced incidents of maltreatment, as evidenced by lower reports of child abuse and neglect over a 24-month follow-up period.

Parents in the program received training in health care, positive parent-child interactions, and home safety, which contributed to their improved parenting skills compared to a comparison group receiving different interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using recidivism data to evaluate project safecare: teaching bonding, safety, and health care skills to parents. Gershater-Molko, RM., Lutzker, JR., Wesch, D.[2019]

Over a 5-year study involving parents of pediatric cancer patients, psychological distress significantly decreased from the time of diagnosis to 5 years later, indicating a potential long-term improvement in mental health.

For fathers, dissatisfaction with social support and negative interactions had a significant impact on their psychological distress, while no similar effects were observed for mothers, suggesting different dynamics in how support affects each parent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological distress and the impact of social support on fathers and mothers of pediatric cancer patients: long-term prospective results. Wijnberg-Williams, BJ., Kamps, WA., Klip, EC., et al.[2015]

The Cancer PEPSONE Program (CPP) helped stabilize family function in children of parents with cancer, while the control group experienced a significant decline in family function, indicating the program's potential to support family dynamics during a challenging time.

Although the CPP did not significantly reduce children's anxiety or improve their overall quality of life, it highlighted the importance of enhancing social support for well parents, which could indirectly benefit children's emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects on Children's Anxiety and Quality of Life of a Psychoeducational Program for Families Living With Parental Cancer and Their Network: A Randomized Controlled Trial Study. Hauken, MA., Pereira, M., Senneseth, M.[2019]

The SAFE® program significantly improved secure attachment between infants and their fathers, with 84.6% of infants in the SAFE group securely attached compared to 65.8% in the control group, based on a year-long randomized control trial.

While the program effectively enhanced father-infant attachment, it did not show a significant difference in secure attachment between mothers and infants, indicating a targeted impact on father involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

*The efficacy of the attachment-based SAFE® prevention program: a randomized control trial including mothers and fathers. Walter, I., Landers, S., Quehenberger, J., et al.[2020]

The mindfulness-based parenting (MBP) intervention significantly reduced general stress levels in women with substance use disorder, as shown by a decrease in scores on the Perceived Stress Scale-10 after 12 weeks of weekly sessions.

Women with the highest initial stress levels experienced the most significant improvements, indicating that MBP could be particularly beneficial for those under the most stress, thus supporting its integration into treatment programs for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Stress Among Mothers in Drug Treatment: A Description of a Mindfulness Based Parenting Intervention. Short, VL., Gannon, M., Weingarten, W., et al.[2019]

Parents of children undergoing bone marrow transplantation experience the highest levels of stress before the transplant, indicating a critical time for psychological support.

While a pilot intervention program helped mothers use more stress management techniques, it did not significantly reduce stress levels compared to standard care, highlighting the need for more effective strategies during this challenging period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief report: parents of children undergoing bone marrow transplantation: documenting stress and piloting a psychological intervention program. Streisand, R., Rodrigue, JR., Houck, C., et al.[2019]

The Parent Line program effectively improves the health and development of low-income children by providing regular telephone contact with nurses, which parents find helpful and supportive.

This telephone intervention not only offers timely social and emotional support but also delivers essential education and advocacy for families, highlighting its value in pediatric nursing practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent Line: nurse telephone intervention for parents and caregivers of children from birth through age 5. Moore, ML., Krowchuk, H.[2019]

The KEEP (Keeping Foster Parents Trained and Supported) intervention effectively reduced externalizing behavior problems in children in foster care, based on a study involving 335 foster and kinship families.

The intervention not only helped improve behavior in multiple children within the same household but also significantly reduced parental stress related to managing these behavior issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the KEEP Foster Parent Intervention on Child and Sibling Behavior Problems and Parental Stress During a Randomized Implementation Trial. Price, JM., Roesch, S., Walsh, NE., et al.[2018]

The SKKIPPI project is a comprehensive multicenter research initiative aimed at understanding and addressing parental psychological stress and its impact on parent-child relationships, involving a population-based cohort study and two randomized controlled trials (RCTs).

The RCTs will specifically evaluate the effectiveness of a focused parent-infant psychotherapy (ESKP) in improving maternal sensitivity and mother-child attachment, with the goal of enhancing child development and reducing psychological symptoms in both mothers and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postpartum mental health problems: healthcare service situation and effectiveness of parent-infant psychotherapy. Presentation of the SKKIPPI project funded by the German Innovationsfonds]. Eckert, M., Richter, KM., Mattheß, J., et al.[2020]

The DELFIN behavioral group training program significantly improved parenting behavior in conflict situations among parents of children with type 1 diabetes after 3 months, with effects remaining stable after 12 months.

Parents in the intervention group experienced reduced depression and anxiety scores, indicating potential psychological benefits, although the differences compared to the control group were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing stress and supporting positive relations in families of young children with type 1 diabetes: a randomized controlled study for evaluating the effects of the DELFIN parenting program. Sassmann, H., de Hair, M., Danne, T., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06294392

Study Details | NCT06294392 | KEEP Connecting Kin Targeted child outcomes include (a) child well-being (i.e., behavioral and emotional functioning, including child internalizing and externalizing behaviors) and ...

2. keepforfamilies.org keepforfamilies.org/research/

Research - KEEP: Evidence-Based Support for Families Our evidence-based support strategies help foster, kinship, and adoptive families succeed. Outcomes include reduced parent stress, lower rates of placement ...

3. oslcdevelopments.org oslcdevelopments.org/keep-connecting-kin-2023/

KEEP® Connecting Kin (2023) This study aims to evaluate whether scaling-out and adapting the KEEP intervention for families experiencing informal kinship care can (a) prevent problems.

4. acf.gov acf.gov/opre/project/prevention-services-evaluation-partnerships-building-evidence-mental-health-substance

Prevention Services Evaluation Partnerships: Building ... The study will examine the impact of the KEEP-CK program on 1) child and adult outcomes (e.g., child permanency, child wellbeing, parenting practices, parent/ ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3555514/

Effectiveness of the KEEP Foster Parent Intervention during ... In prior research, the KEEP intervention was found to be effective in reducing child behavior problems. In the current study, the KEEP foster parent ...

6. keepforfamilies.org keepforfamilies.org/keepconnectingkin/

KEEP Connecting Kin - What is KEEP Connecting Kin? · Parent training and support groups for families caring for the youth of family or friends, not formally involved ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7371572/

Parenting Intervention Outcomes for Kinship Caregivers and ... This study systematically summarizes the effect of parenting interventions on kinship foster caregivers and their cared for children.