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

60 Participants Needed

Trial Summary

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 data supports the idea that Project Support for Parenting and Child Mental Health is an effective treatment?

The available research does not provide specific data on the effectiveness of Project Support for Parenting and Child Mental Health. Instead, it discusses various other parenting interventions for parents with mental illness, such as the Baby Triple P Positive Parenting Program and an Internet-based educational intervention. These studies focus on improving parenting skills, coping, and reducing stress, but they do not mention Project Support specifically. Therefore, there is no direct evidence from the provided information to support the effectiveness of Project Support for Parenting and Child Mental Health. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Project Support for Parenting and Child Mental Health?

The Baby Triple P Positive Parenting Program, similar to Project Support, was found to enhance parenting skills and improve mental health outcomes for mothers with severe mental health issues, suggesting that structured parenting interventions can be beneficial in improving parent-child relationships and mental health. ^{1 2 3 5 6}

What safety data is available for Project Support parenting treatment?

The provided research does not directly address safety data for Project Support or its variants. The systematic review on adverse event monitoring in pediatric psychosocial interventions may offer insights into general safety considerations for similar treatments, but specific safety data for Project Support is not mentioned. ^{7 8 9 10 11}

Is Project Support a promising treatment for parenting and child mental health?

Yes, Project Support is a promising treatment because it focuses on improving the parent-child relationship and enhancing mental health, which are key factors in achieving better outcomes for both parents and children. ^{2 3 12 13 14}

How is the Project Support treatment different from other parenting support treatments?

Project Support is unique because it focuses on enhancing the parent-child relationship and addressing mental health symptoms in a supportive social setting, integrating activities like dance play and reflective diary keeping, which are not commonly found in other parenting programs. ^{2 3 12 13 14}

What is the purpose of this trial?

In this study, the investigators will conduct a proof-of-concept pilot trial of delivering the Project Support Positive Parenting Module (Project Support) to n = 30 families waiting for trauma-focused services. Investigators hypothesize that Project Support will be feasible and acceptable as evidenced by benchmarks for recruitment, retention at post assessment, engagement, fidelity, and program satisfaction. Investigators will also explore trends on caregiver emotional support, parenting self-efficacy, and child mental health symptoms.

Research Team

Caitlin Rancher, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

My child is between 5 and 12 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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 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 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]

References

1. Switzerland 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. [2023]

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

The implementation of a culturally tailored parenting support programme for Somali immigrant parents living in Sweden-A process evaluation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Parenting and mental illness: a pilot group programme for parents. [2018]

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

Randomized Controlled Trial of an Internet-Based Educational Intervention for Mothers With Mental Illnesses: An 18-Month Follow-Up. [2020]

5. Australia pubmed.ncbi.nlm.nih.gov

Intervention programs for children whose parents have a mental illness: a review. [2019]

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

Group Work Intervention for the Parents of Children with Mental Health Issues Admitted in the Tertiary Care Center. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

8. England 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. [2022]

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

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

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

One intensive care nursery's experience with enhancing patient safety. [2006]

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

Translation of an evidence-based tailored childhood injury prevention program. [2022]

12. England 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. [2019]

13. England 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. [2011]

14. Switzerland 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. [2023]