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

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ClinicalTrials.gov Identifier: NCT03524664
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Christie Petrenko, University of Rochester

Brief 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

Condition or disease Intervention/treatment Phase
Fetal Alcohol Spectrum Disorders Behavioral: Tuning In to kids intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parent Emotion Socialization and Child Emotion Regulation in FASD
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Delayed "tuning in to kids" intervention
Children with fetal alcohol spectrum disorder and their parents
Experimental: "Tuning in to kids" intervention
Children with fetal alcohol spectrum disorder and their parents
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.




Primary Outcome Measures :
  1. mean change in parent awareness of own emotion score for sadness [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  2. mean change in parent acceptance of own expression score for sadness [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  3. mean change in parent regulation of own emotions score for sadness [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  4. mean change in parent awareness of child emotion score for sadness [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  5. mean change in parent acceptance of child's emotion score for sadness [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  6. mean change in parent emotion coaching score for sadness [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  7. mean change in child regulation score for sadness [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  8. mean change in parent awareness of own emotion score for anger [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  9. mean change in parent acceptance of own expression score for anger [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  10. mean change in parent regulation of own emotions score for anger [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  11. mean change in parent awareness of child emotion score for anger [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  12. mean change in parent acceptance of child's emotion score for anger [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  13. mean change in parent emotion coaching score for anger [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  14. mean change in child regulation score for anger [ Time Frame: baseline to 8 weeks ]
    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 are audiotaped and transcribed verbatim. 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 emotions. The scores range from 1-5 with 5 indicating better outcome.

  15. mean change in proportion of observed emotion coaching statements using the Family Narrative Task [ Time Frame: baseline to 8 weeks ]
    The Family Narrative Task is a parent-child interaction task assessing how parents communicate about emotions with their children. Parents are instructed to engage the child in a conversation about three emotional events in turn: a positive family experience, a difficult family experience, and a time when the child misbehaved. Interactions are videotaped and coded for content and function using the Family Emotion Communication Scoring System, Revised. Emotion coaching (e.g., "I could tell you were mad because you walked away," "How did you feel when that happened?") and dismissing (e.g., "It wasn't anything to get upset over," abrupt change in topic) will be coded. Number of emotion coaching statements versus total statements will be calculated.

  16. mean change in proportion of observed emotion dismissing statements using the Family Narrative Task [ Time Frame: baseline to 8 weeks ]
    The Family Narrative Task is a parent-child interaction task assessing how parents communicate about emotions with their children. Parents are instructed to engage the child in a conversation about three emotional events in turn: a positive family experience, a difficult family experience, and a time when the child misbehaved. Interactions are videotaped and coded for content and function using the Family Emotion Communication Scoring System, Revised. Emotion coaching (e.g., "I could tell you were mad because you walked away," "How did you feel when that happened?") and dismissing (e.g., "It wasn't anything to get upset over," abrupt change in topic) will be coded. Number of emotion coaching statements versus total statements will be calculated.

  17. mean change in child emotion regulation using the Emotion Regulation Checklist [ Time Frame: baseline to 20 weeks ]
    The Emotion Regulation Checklist is a 24-item parent report questionnaire assessing children's affect lability (e.g., "exhibits wide mood swings," "is easily frustrated") and emotion regulation (e.g., "is empathetic towards others," "can say when s/he is feeling sad, angry, fearful, or afraid"). This assessment is 24 items rated by the parent on a 4 point scale of never to always given at baseline, 8 and 20 weeks. There are 12 items of lability and 12 items of emotion regulation. For emotion regulation the score ranges from 12-48 with higher scores reflecting better emotion regulation.

  18. mean change in child lability/negativity using the Emotion Regulation Checklist [ Time Frame: baseline to 20 weeks ]
    The Emotion Regulation Checklist is a 24-item parent report questionnaire assessing children's affect lability (e.g., "exhibits wide mood swings," "is easily frustrated") and emotion regulation (e.g., "is empathetic towards others," "can say when s/he is feeling sad, angry, fearful, or afraid"). This assessment is 24 items rated by the parent on a 4 point scale of never to always given at baseline, 8 and 20 weeks. There are 12 items of lability and 12 items of emotion regulation. For lability/negativity the score ranges from 12-48 with higher scores reflecting worse outcome.

  19. mean change in Respiratory sinus arrhythmia in children [ Time Frame: baseline to 8 weeks ]
    ActiveWave Cardio is an ambulatory single channel ECG waveform recorder that will be used to measure baseline levels and changes in respiratory sinus arrhythmia (RSA) in response to the Disappointment Task. The change in RSA will be measured before and after the disappointment task. The change over time will be calculated.

  20. mean change in intensity of negative emotion during the disappointment task [ Time Frame: baseline to 8 weeks ]
    The Disappointment Task measures children's intensity of negative affect (5-point Likert scale) and is coded in response to a disappointment. The range in score is 1-5 with 1 being less intense negative emotions

  21. mean change in intensity of disruptive behaviors using the Eyberg Child Behavior Inventory [ Time Frame: baseline to 20 week. ]
    The Eyberg Child Behavior Inventory is a 36-item scale assessing the intensity of disruptive behaviors in children. Parents rate each item on a 7 point scale. This is then converted into a standardize score with a T score with mean of 50 and standard deviation of 10 with higher scores reflecting more problems. This is given at baseline, 8 and 20 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Families will be eligible for the study if they:

  • Have a child between the age of 4 and 12 with a formal diagnosis of an FASD based on the Revised 2016 Hoyme criteria (Hoyme et al., 2016)
  • The child is in some form of out of home care (e.g., adoptive, foster, relative, or other legal guardian)
  • The child has resided with the primary caregiver for at least a year and be expected to remain in that placement for at least 6 months (study duration).

Exclusion Criteria:

  • A history of other genetic, neurological, or significant medical conditions, traumatic brain injury, serious psychiatric illness or disability that would preclude data collection
  • Child has a moderate to severe intellectual disability (IQ < 55)
  • Child or caregiver has insufficient proficiency in English
  • Caregiver is a biological parent of the child with FASD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524664


Contacts
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Contact: Christie Petrenko 585-275-2991 christie_petrenko@urmc.rochester.edu

Locations
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United States, New York
Mt. Hope Family Center Recruiting
Rochester, New York, United States, 14608
Principal Investigator: Christie L Petrenko, Ph.D.         
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)

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Responsible Party: Christie Petrenko, Research Associate, University of Rochester
ClinicalTrials.gov Identifier: NCT03524664     History of Changes
Other Study ID Numbers: RSRB69545
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders