CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 118 enrolled
Drug / intervention
Tuning In to kids interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03524664
NCT03524664N/ACompleted

Parent Emotion Socialization and Child Emotion Regulation in FASD

University of Rochester·interventional·Posted May 15, 2018·Updated Nov 4, 2022

In Brief

A clinical study evaluating Tuning In to kids intervention for Fetal Alcohol Spectrum Disorders. Completed, enrolled 118 participants across 1 site.

Detailed Summary

The purpose of this study is to learn about the emotion regulation skills of children with fetal alcohol spectrum disorders (FASD) and different strategies that may improve these skills. This study is also testing whether a training program taught to caregivers is helpful. Children will be asked to: * Complete a brief measure of verbal and nonverbal problem-solving skills. * Play two computer games. * Have their heart rate measured while completing a task that is designed to be mildly disappointing. Two ECG pads are placed on the chest with a small recorder. * Play or relax with study staff while you are finishing caregiver activities. Caregivers will be asked to complete interviews and questionnaires about: * the child's background, including any past stressful experiences * the child's behavior and how s/he handles emotions * caregiver views on the child's emotions and their own * caregiver relationship with the child * Stress caregivers experience as a parent

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 15, 2018
Enrollment StartAug 13, 2018
Primary CompletionSep 30, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 8.1 years ago

Interventions

Tuning In to kids interventionbehavioral

The Tuning Into Kids Program involves: * Meeting in a small group with other caregivers raising children with FASD. * 8-week program that meets weekly for 2 hours at Mt. Hope Family Center or other community location. * Learn and practice an approach of responding to children's emotions and behavior.