What side effects are associated with this type of intervention?

Common treatments for parenting stress, such as cognitive-behavioral therapy (CBT) and mindfulness therapy, generally have minimal side effects. CBT may occasionally cause temporary increases in anxiety or emotional discomfort as individuals confront challenging thoughts and behaviors. Mindfulness therapy is considered low risk but may not be effective for everyone. Other supportive interventions, such as social support and stress management techniques, typically have few adverse effects but require consistent engagement to be beneficial. Overall, these treatments are safe and well-tolerated, with the primary side effect being the emotional effort required to participate actively in therapy.

What prior FDA approvals exist?

There are no FDA-approved treatments specifically for 'parenting' as it is not a medical condition. However, treatments for related psychological issues such as anxiety and depression, which can impact parenting, include FDA-approved medications like selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT). These treatments align with the multimodal psychological and health support strategies aimed at mitigating the psychological and health impact on parents.

What other types of research exist?

Promising novel alternatives for parenting patients in 2024 include: 1) Video-delivered family therapeutic interventions, such as the Resilience Enhancement Skills Training (REST), which have shown high feasibility and acceptability for perinatal women with depressive symptoms and family conflict. 2) Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered through digital platforms, which can improve sleep-related quality of life and reduce psychological distress. 3) Integrative health approaches, including the use of probiotics and dietary supplements, which have shown potential benefits in pediatric populations and could be adapted for parents. These alternatives offer accessible and effective options for mitigating psychological and health impacts in parenting patients.

← Back to Search

CARE Program + Valera App Interventions for Parenting Challenges During Coronavirus (CARE Trial)

N/A

Recruiting

Led By Vilma Gabbay, MD

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Primary language other than Spanish or English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the CARE program and Valera Health app to help stressed caregivers in the Bronx. The CARE program offers group sessions for emotional support, while the Valera Health app provides digital mental health resources. These interventions aim to reduce stress and improve mental health among caregivers.

Who is the study for?

This trial is for primary caregivers in the Bronx experiencing high stress, especially those working on-site at Montefiore Medical Center or patients in psychiatric and rheumatology clinics there. It includes grandmothers and aunts but excludes those with neurocognitive issues, serious psychiatric/substance use problems, active child abuse cases, non-Spanish/English speakers, or prior similar app users.

What is being tested?

The study tests various combinations of the CARE Program and Valera Application to alleviate parental stress due to COVID-19. Some will use both tools with added care manager support; others will try each tool separately or combined without extra support.

What are the potential side effects?

Since this trial involves psychological interventions rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing personal challenges related to parenting during the pandemic.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My primary language is not English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Perceived Stress

Secondary study objectives

Beck Anxiety Index

Beck Depression Index

Beck Suicide Scale Inventory

+5 more

Other study objectives

Alcohol Use Disorders Identification Test (Audit C)

COVID Impact Scale

Drug Abuse Screening Test

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Parents of children receiving mental health treatment at MontefioreExperimental Treatment3 Interventions

Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app .

Group II: Parents of children being treated for autoimmune disorders at MontefioreExperimental Treatment3 Interventions

Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.

Group III: Healthcare workers at MontefioreExperimental Treatment3 Interventions

Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The multimodal parent-focused intervention includes strategies such as psychological support, financial assistance, and telehealth services. Psychological support mechanisms often involve cognitive-behavioral therapy (CBT) to help parents manage stress, anxiety, and depression by changing negative thought patterns and behaviors. Financial assistance aims to alleviate economic stressors that can exacerbate mental health issues. Telehealth services provide accessible healthcare options, reducing barriers to receiving timely support. These mechanisms are crucial for parenting patients as they help mitigate the psychological and health impacts of the pandemic, enabling parents to provide better care and support for their children, thereby breaking potential cycles of stress and trauma.

Diagnosis and management of trichotillomania in children and adolescents.