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A Study of Parent and Child Emotions in Fetal Alcohol Spectrum Disorder (FASD)

NCT03524664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2022-11-04

Study results available
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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

Conditions

  • Fetal Alcohol Spectrum Disorders

Interventions

BEHAVIORAL

Tuning In to kids intervention

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • University of Rochester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03524664 on ClinicalTrials.gov