Project Support for Parent-Child Relationship

Overseen By Research Coordinator

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: 2

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how Project Support can enhance family dynamics and support for children awaiting trauma-focused services. Families will be divided into two groups: one will receive Project Support, which includes additional case management services, while the other will continue with standard care. The study seeks families with a child aged 6 to 13 who has lived with them for at least six months and is in need of trauma-focused help. Participants must also be able to access services via telehealth. As an unphased trial, this study offers families the chance to contribute to innovative approaches in trauma support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on family support and trauma services, so it's unlikely that medication changes are required.

What prior data suggests that Project Support is safe for families?

Research has shown that Project Support may improve parenting and reduce stress in families. Some studies found it can decrease violence against children and help mothers feel less stressed. While results can vary, no major reports of harmful side effects exist, indicating the program is generally safe. Participants typically find the program easy to follow and helpful. For those considering joining a trial for Project Support, evidence suggests it is a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Project Support because it offers a hands-on approach to strengthening parent-child relationships through targeted support and case management, which is not typically part of standard care. Unlike traditional treatments that may focus solely on providing general case management services, Project Support involves a detailed assessment of parenting behaviors and mental health, aiming to directly address these areas with tailored interventions. This method has the potential to enhance service satisfaction and improve outcomes by offering personalized support, setting it apart from existing options.

What evidence suggests that Project Support is effective for improving parent-child relationships?

Research has shown that involving parents in their child's mental health treatment is usually beneficial. This approach often leads to better therapy outcomes for children. A review found that programs focusing on parenting and family positively affect mental health in various situations. Another study suggested that improving the parent-child relationship can enhance a child's social and emotional growth in early years. In this trial, participants in the experimental arm will receive Project Support, which directly involves parents in mental health care and may offer potential benefits. Meanwhile, participants in the control arm will receive treatment as usual, including routine case management services. ^{6 7 8 9 10}

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 awaiting trauma-focused services. They must be able to complete assessments of family functioning and trauma characteristics at the start, and again 4-6 weeks later.

Inclusion Criteria

Family is seeking trauma-focused services for their child

My child is between 6 and 13 years old.

Caregiver agreed to be contacted for volunteer research opportunities

Exclusion Criteria

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

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment on demographics, parenting behaviors, and mental health symptoms

1 week

1 visit (virtual)

Treatment

Participants receive Project Support or treatment as usual, with a post-test assessment 4-6 weeks after baseline

6 weeks

1 visit (virtual)

Follow-up

Participants are monitored for attendance to trauma-focused treatment intake session

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Project Support

Trial Overview The study compares Project Support, which offers case management services, against usual treatment without these additional services. Families are randomly assigned to one of the two groups after initial assessment.

How Is the Trial Designed?

Group I: Treatment as usual Experimental Treatment 1 Intervention

All participants will complete a baseline assessment on demographics, parenting behaviors, and mental health symptoms. Participants randomized to the treatment as usual condition will receive routine provision of case management services. Approximately 4-6 weeks after the baseline assessment all participants will complete a post-test assessment that includes measures of service satisfaction.

Group II: Project Support Experimental Treatment 2 Interventions

All participants will complete a baseline assessment on demographics, parenting behaviors, and mental health symptoms. Participants randomized to the experimental condition will receive Project Support and be offered case management services. Approximately 4-6 weeks after the baseline assessment all participants will complete a post-test assessment that includes measures of service satisfaction.

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

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]

Empowering parents in pediatric intensive care can significantly enhance the quality of care by incorporating their satisfaction and experiences into quality improvement initiatives.

A framework that focuses on family-centered care and parental needs can lead to effective quality improvement projects, ultimately benefiting both parents and healthcare teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent satisfaction in the pediatric ICU. Latour, JM., van Goudoever, JB., Hazelzet, JA.[2008]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11425941/

Systematic review and meta-analysis of interventions to ... Interventions directly addressing the well-being for parents of children with anxiety and/or depression appear not to be effective overall.

2. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.psychotherapy.20220025

Involving Parents in Child Mental Health Treatments Child therapy outcomes research has indicated that involving parents in child mental health treatments is generally beneficial.

3. scholarworks.lib.csusb.edu scholarworks.lib.csusb.edu/cgi/viewcontent.cgi?article=3457&context=etd

Effectiveness of Mental Health Interventions Amongst ... First, it seeks to address critical gaps in the literature by focusing on the effectiveness of mental health interventions for parents rather ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7781063/

Parenting and Child Development: A Relational Health ... This review presents a parent-child relational health perspective on development, with an emphasis on socioemotional outcomes in early childhood.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0010440X24000348

Parenting and family interventions in lower and middle ... Our review found promising effects of parenting and family interventions for mental health outcomes across country contexts.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10209692/

Effects over time of parenting interventions to reduce physical ... Our findings suggest that parenting interventions can reduce physical and emotional violence against children. Effects are maintained up to 24 months follow-up.

7. urban.org urban.org/sites/default/files/2023-09/FamilySafe%20Project%20Evaluation.pdf

FamilySafe Project Evaluation Overall, intervention programs that involve the children and mother are generally more effective in addressing externalizing problems and ...

8. whatworks-csc.org.uk whatworks-csc.org.uk/evidence/evidence-store/intervention/interventions-for-women-parenting-in-the-context-of-intimate-partner-violence/

Interventions for Women Parenting in the Context of Intimate ... Both Child-Parent Psychotherapy and Project Support showed promise in reducing maternal distress and improving parenting, although findings are mixed. Results ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/27/NCT04729127/Prot_SAP_000.pdf

A Randomized Trial of Project ImPACT, an evidence-based ... Little data are available on how many contact hours are necessary to change parent behavior, produce positive child outcomes, or the associated cost-benefit.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8876176/

Project STRONG: An Online, Parent-Son Intervention for ... This study assessed the initial feasibility, acceptability, and efficacy of an online, parent-son intervention (STRONG) aimed at reducing dating aggression ...