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NCT03524664 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of Rochester.

Completed
Registry status
NA
Development phase
118
Enrollment target

NCT03524664: Completed NA study, sponsored by University of Rochester.

NCT03524664 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 118 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03524664, a NA study, has completed, sponsored by University of Rochester.

COMPLETED
Registry status
NA
Development phase
118 participants
Enrollment target

Study 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

Primary Outcome

The meta emotion interview is a semi-structured interview administered to parents about their own experience of anger and sadness and their feelings, attitudes, and behaviors toward their children's anger and sadness. Interviews can be analyzed quantitatively using a checklist rating system. The Revised Meta-Emotion coding system uses a 5-point Likert scale (1= strongly disagree to 5= strongly agree) with which coders rate each item based on both the content and the way parents talk about emotio

Interventions

  • BEHAVIORAL Tuning In to kids intervention

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2018-08-13
Est. Completion 2021-09-30
Phase NA
University of Rochester

636 total trials

What the finished NCT03524664 record still lists

NCT03524664 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Tuning In to kids intervention is the first listed.

NCT03524664 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03524664 about?

NCT03524664 is a clinical study titled "A Study of Parent and Child Emotions in Fetal Alcohol Spectrum Disorder (FASD)". 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...

What is the current status of trial NCT03524664?

This trial is currently completed. It is a NA study. The enrollment target is 118 participants. The study started on 2018-08-13. Estimated completion is 2021-09-30.

What interventions are being tested in trial NCT03524664?

The interventions under investigation include: Tuning In to kids intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT03524664?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03524664's enrollment target sits among peer trials

118 803rd of 2000 higher than 1,194 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03524664, the US trial registry maintained by the National Library of Medicine. NCT03524664 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.