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Behavioral Intervention

Intervention for Self-Regulation

N/A

Recruiting

Led By Nada M Goodrum, Ph.D.

Research Sponsored by University of South Carolina

Eligibility Criteria Checklist

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

Must have

Child between the ages of 3-9 years

Parent/caregiver is English speaking.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (t1, weeks 0-2); post-intervention (t2, weeks 16-18); follow-up (t3, week 30)

Awards & highlights

Study Summary

This trial will test a program for parents to help improve the social-emotional and lifestyle behaviors of children aged 3 to 9 in families going through difficult times.

Who is the study for?

This trial is for parents or guardians of children aged 3-9 who are concerned about their child's mood, behavior, or lifestyle health. Participants must be over 18, speak English, and be facing two or more stressors like trauma, mental health issues, HIV, discrimination, substance misuse, or financial strain.Check my eligibility

What is being tested?

The study tests a parent-based program called Family Life Skills Triple P aimed at improving kids' social-emotional well-being and healthy behaviors. It focuses on families under significant stress to see if the program is practical and effective in these settings.See study design

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 3 and 9 years old.

Select...

My parent or caregiver speaks English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (t1, weeks 0-2); post-intervention (t2, weeks 16-18); follow-up (t3, week 30)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (t1, weeks 0-2); post-intervention (t2, weeks 16-18); follow-up (t3, week 30)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t1, weeks 0-2); post-intervention (t2, weeks 16-18); follow-up (t3, week 30) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Child physical activity

Child screen time

Child sleep

+9 more

Secondary outcome measures

Parenting practices

Parenting self-regulation

Parenting stress

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants in the intervention arm will receive a 12-session parent-based prevention program based on Family Life Skills Triple P.

Group II: Waitlist ControlActive Control1 Intervention

Participants in the waitlist control arm will not receive any intervention during the clinical trial. They will be placed on a waitlist and then offered the intervention once post assessments are complete.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of General Medical Sciences (NIGMS)NIH

269 Previous Clinical Trials

247,052 Total Patients Enrolled

University of South CarolinaLead Sponsor

211 Previous Clinical Trials

120,399 Total Patients Enrolled

Nada M Goodrum, Ph.D.Principal InvestigatorUniversity of South Carolina

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this clinical trial currently open?

"As per the details on clinicaltrials.gov, this investigation is currently in the process of enrolling participants. The study was first made available on February 9th, 2024 and underwent its latest revision on February 14th, 2024."

Answered by AI

How many individuals in total will be participating in this medical study?

"Indeed, information from clinicaltrials.gov confirms that the ongoing trial is actively seeking volunteers. This particular study was initially listed on February 9th, 2024 and most recently revised on February 14th of the same year. The research team aims to enroll a total of 60 participants at one designated location."

Answered by AI

Does this medical study include individuals above the age of 40?

"Participants eligible for this research must be between the ages of 3 and 9. Specifically, there are 88 trials catering to individuals under 18 years old and 105 studies targeting those above 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Strengthening Child Social-Emotional and Lifestyle Health in Families Experiencing Stress

Nada Goodrum 2024. "Strengthening Child Social-Emotional and Lifestyle Health in Families Experiencing Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06163703.

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