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

192 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the KEEP-CK treatment for reducing parenting stress?

Research on similar treatments, like the DELFIN parenting program and a mindfulness-based parenting intervention, shows that structured behavioral training and mindfulness can reduce parenting stress and improve parenting skills. This suggests that the KEEP-CK treatment may also be effective in reducing parenting stress. ^{1 2 3 4 5}

How is the KEEP-CK treatment different from other treatments for parenting stress?

The KEEP-CK treatment is unique because it focuses on training and supporting foster and kinship caregivers to manage children's behavior problems, which in turn reduces parental stress. This approach is distinct from other treatments as it is specifically designed for caregivers in foster care settings and has been shown to be effective in reducing stress and behavior issues in multiple children within the same household. ^{6 7 8 9 10}

Research Team

Stacey Tiberio, Ph.D.

Principal Investigator

Oregon Social Learning Center

Eligibility Criteria

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

Focal child has a developmental disability or delay that impairs their ability to be responsive to the parenting content of KEEP-CK.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

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]

References

1. Germany 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]. [2020]

2. England 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. [2021]

3. United States 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. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Brief report: parents of children undergoing bone marrow transplantation: documenting stress and piloting a psychological intervention program. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Reducing Stress Among Mothers in Drug Treatment: A Description of a Mindfulness Based Parenting Intervention. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States 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. [2019]

8. England pubmed.ncbi.nlm.nih.gov

*The efficacy of the attachment-based SAFE® prevention program: a randomized control trial including mothers and fathers. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Using recidivism data to evaluate project safecare: teaching bonding, safety, and health care skills to parents. [2019]

10. United States 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. [2018]