Project Support for Parenting and Child Mental Health

Overseen By Caitlin Rancher, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Traumatic brain injury, developmental disability, psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Project Support, which helps parents enhance their parenting skills and provide emotional support to children who have experienced trauma. Researchers aim to determine if this approach is practical and beneficial for families awaiting trauma-focused services. Suitable families include those with children aged 5-12 who have lived with their caregiver for at least six months and can participate in telehealth services.

As an unphased trial, this study offers families access to support and resources that can significantly impact their lives.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

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

What prior data suggests that the Project Support Positive Parenting Module is safe for families?

Research has shown that Project Support is a well-researched parenting program designed to enhance how caregivers support and interact with their children. A previous study on a similar program aimed at helping caregivers after a child experienced trauma showed positive results. Specifically, caregivers felt more supported and confident in their abilities.

Although specific safety studies on Project Support have not been conducted, it is important to note that this is a behavioral program, not a medication. This typically means fewer risks compared to medical treatments. Participants in similar programs have not reported major negative effects, indicating it is generally well-received. Overall, Project Support appears to be a safe choice for families seeking to improve their parenting skills and support their children's mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Project Support is unique because it focuses on providing direct assistance to caregivers, aiming to improve both parenting skills and child mental health in a short period of 4-6 weeks. Unlike standard treatments that often involve individual therapy sessions for children or parents, Project Support emphasizes hands-on guidance and support for caregivers in their home environment. Researchers are excited because this approach has the potential to create a more immediate and impactful change in family dynamics, promoting better mental health outcomes for children by empowering their caregivers.

What evidence suggests that Project Support might be an effective treatment for child mental health?

Research has shown that the Project Support Positive Parenting Module can assist families dealing with child trauma. In a previous study, caregivers who participated in Project Support reported increased confidence in their parenting and improved ability to provide emotional support. Families in the program also observed improvements in their children's behavior. These results suggest that Project Support could effectively aid both caregivers and children. Early findings support its potential benefits for families awaiting trauma-focused services. ^{1 2 6 7 8}

Who Is on the Research Team?

Caitlin Rancher, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for families with a child aged 5-12 who have experienced trauma and are on a waitlist for services at the National Crime Victims Center. The caregiver must have been living with the child for at least 6 months, be willing to participate in research, and can communicate in English or Spanish.

Inclusion Criteria

My child and I can communicate in English or Spanish.

Child has been living with caregiver for at the last 6 months or longer

Caregiver agreed to be contacted for volunteer research opportunities

Exclusion Criteria

Child or caregiver has a diagnosis that would impair their ability to participate in or benefit from services (e.g., traumatic brain injury, developmental disability, psychosis)

Child is in Foster Care or Department of Social Services custody

The caregiver is unwilling or unable to give informed consent and/or the child is unwilling and unable to give assent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers receive the Project Support intervention via telehealth

4-6 weeks

Telehealth sessions

Follow-up

Participants are monitored for changes in supportive parenting, self-efficacy, and child mental health symptoms

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Project Support

Trial Overview The study tests 'Project Support,' a positive parenting module aimed at improving parent-child relationships while waiting for trauma-focused services. It will measure how well families engage with the program and its impact on parenting skills and children's mental health.

How Is the Trial Designed?

Group I: Project Support Experimental Treatment 1 Intervention

All caregivers will receive the Project Support intervention over the course of 4-6 weeks.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A culturally tailored parenting support program significantly improved the mental health of Somali-born parents, as evidenced by a notable increase in their General Health Questionnaire scores after 12 weeks of intervention.

The program also enhanced parents' sense of competence and satisfaction in their parenting roles, indicating that culturally sensitive support can effectively address the unique needs of immigrant families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a culturally tailored parenting support programme in Somali-born parents' mental health and sense of competence in parenting: a randomised controlled trial. Osman, F., Salari, R., Klingberg-Allvin, M., et al.[2019]

A safety program was developed in a unit caring for critically ill infants to enhance the safety culture and reduce medical errors, which can have severe consequences for this vulnerable population.

Key strategies included forming an interdisciplinary safety team, conducting safety rounds, and involving parents in risk assessment, leading to improved safety outcomes and suggesting a model for other healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One intensive care nursery's experience with enhancing patient safety. Alton, M., Mericle, J., Brandon, D.[2006]

The Safe n' Sound program, aimed at reducing unintentional childhood injuries, has been successfully adapted for use in general clinic settings, making it more accessible to parents and healthcare providers.

Key steps in the adaptation process included assessing clinic needs, shortening and updating the program content, and creating promotional materials, which were essential for effective implementation and collaboration with clinic staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation of an evidence-based tailored childhood injury prevention program. Weaver, NL., Williams, J., Jacobsen, HA., et al.[2022]

A systematic review of 52 studies highlights that effective parenting interventions, from the prenatal period to adolescence, can significantly improve both parenting quality and children's mental health outcomes.

The review emphasizes the need for skilled professionals to implement these evidence-based programs and calls for further research to develop targeted interventions for high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenting for mental health: what does the evidence say we need to do? Report of Workpackage 2 of the DataPrev project. Stewart-Brown, SL., Schrader-McMillan, A.[2011]

The Acorn program effectively improved the quality of parent-child interactions and enhanced mothers' wellbeing, confidence, and social support among 353 vulnerable mothers, including those with significant mental health issues like borderline personality disorder and depression.

Participants reported lasting positive changes in their parenting and emotional connection with their children, highlighting the program's potential as a valuable intervention for addressing maternal mental health and its impact on parenting, especially in the context of increased stress from the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holistic community-based group parenting programs for mothers with maternal mental health issues help address a growing public health need for a diversity of vulnerable mothers, children and families: Findings from an action research study. Aylward, P., Sved Williams, A.[2023]

The Baby Triple P Positive Parenting Program (BTP) was found to be feasible and highly acceptable for mothers with severe mental illness in a Mother and Baby Unit setting, with 75% of participants completing the intervention.

Participants who received BTP showed potential improvements in maternal parenting competence, bonding, and mental health symptoms, suggesting that this intervention could enhance treatment outcomes for mothers in similar situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Randomized Controlled Trial of a Parenting Intervention Offered to Women With Severe Mental Health Problems and Delivered in a Mother and Baby Unit Setting: The IMAgINE Study Outcomes. Wittkowski, A., Emsley, R., Bee, PE., et al.[2023]

Involving patients and their families in healthcare adverse event reviews can lead to better outcomes, including reconciliation after trauma and restored trust in the healthcare system, as highlighted by interviews with 19 participants in NHS Scotland.

A collaborative and person-centered approach to these reviews not only enhances learning for healthcare providers but may also reduce the risk of similar adverse events in the future, suggesting that effective communication can decrease litigation claims.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reviews in healthcare: what matters to patients and their family? A qualitative study exploring the perspective of patients and family. McQueen, JM., Gibson, KR., Manson, M., et al.[2022]

The Parenting and Mental Illness Group Program, a 6-week initiative followed by individual home visits, showed positive effects on children's behavior and parenting practices based on assessments from the Eyberg Child Behaviour Inventory and Parenting Scale.

Participants reported favorable views of the program, suggesting its potential effectiveness, but further research with larger groups and evaluations in different locations is needed to confirm these initial findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenting and mental illness: a pilot group programme for parents. Phelan, R., Lee, L., Howe, D., et al.[2018]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

The Internet-based educational intervention combined with peer support significantly reduced parental stress among 131 mothers with serious mental illnesses, showing lasting effects even 18 months after the intervention.

This low-cost and accessible approach highlights the potential for online resources to effectively support parenting skills and coping strategies for mothers facing mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of an Internet-Based Educational Intervention for Mothers With Mental Illnesses: An 18-Month Follow-Up. O'Shea, A., Kaplan, K., Solomon, P., et al.[2020]

Various intervention programs aimed at improving outcomes for children of parents with mental illness were identified, including family interventions, peer-support programs, online interventions, and bibliotherapy.

The most effective programs focus on providing psychosocial education to children about mental illness, but more rigorous research is needed to determine the best conditions for enhancing children's outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention programs for children whose parents have a mental illness: a review. Reupert, AE., Cuff, R., Drost, L., et al.[2019]

The parenting support programme successfully engaged 58 out of 60 invited Somali-born parents, demonstrating effective outreach and participation strategies, such as involving key community individuals and providing free transportation.

Participants reported increased knowledge about children's rights and available social services, indicating that the programme not only reached its audience but also positively impacted their understanding and support networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation of a culturally tailored parenting support programme for Somali immigrant parents living in Sweden-A process evaluation. Osman, F., Schön, UK., Klingberg-Allvin, M., et al.[2022]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11300617

Project Details - NIH RePORTER This proposal asserts the adverse effects of child trauma can be interrupted though a brief intervention (the Project Support Positive Parenting Module) that ...

2. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/10497315231212195

Randomized Controlled Pilot Trial: Project Support Positive ... Results: Caregivers who received the Project Support module reported improved caregiver support and parenting self-efficacy, and their families ...

3. researchgate.net researchgate.net/publication/368940735_A_Randomized_Controlled_Pilot_Study_of_the_Project_Support_Positive_Parenting_Module

A Randomized Controlled Pilot Study of the Project ... Discussion: Results suggest that the Project Support Positive Parenting module can result in changes in parental support. ResearchGate Logo.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10640495/

The Triple P System of Evidence-Based Parenting Support Triple P is an integrated, multi-level system of evidence-based parenting support designed to promote the well-being of children and families.

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-04548-8

Study protocol: development and randomized controlled trial ... This study protocol describes the randomized controlled trial of KopOpOuders-PTSD, a blended care preventive parenting intervention for parents with PTSD.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0304387823001372

The (Un)intended impacts of a digital parenting program The paper evaluates a digital parenting program aiming to improve mental health and caregiver–child interactions.

7. pediatrics.jmir.org pediatrics.jmir.org/2022/1/e30795/

Cost-Minimization Analysis - JMIR Pediatrics and Parenting This study aimed to examine the cost-minimization of an online parenting intervention for childhood disruptive behavior problems compared with the staff- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8109838/

Parenting interventions to promote early child development ... We conducted a global systematic review and meta-analysis to evaluate the effectiveness of parenting interventions on ECD and parenting outcomes.