Clinical trial NCT03524664: A Study of Parent and Child Emotions in Fetal Alcohol Spectrum Disorder (FASD)
Official title: Parent Emotion Socialization and Child Emotion Regulation in FASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-05-15
Enrollment: 118
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Children with fetal alcohol spectrum disorders (FASD) have high rates of mental health problems and incur physical and mental health expenditures that are 9 times higher than other children. These mental health problems contribute to poor social adjustment for children with FASD and result in considerable emotional and financial burden for families. Emotion regulation is a core area of impairment in FASD and is implicated in most mental health disorders. Research on empirically validated interventions for children with FASD is limited. Results from two interventions targeting emotion regulation in FASD demonstrate that child-focused interventions are insufficient to habilitate children's emotion regulation to adaptive levels. Research is needed to identify alternate targets for intervention (e.g., parent training, environmental modifications) to improve the emotion regulation difficulties of children with FASD.

This study investigates a novel intervention target to improve the emotion regulation and adaptive functioning of children with FASD. Research with other populations provides ample evidence for the impact of parent emotion socialization on the development of child emotion regulation and other outcomes. In addition, studies demonstrate that parent emotion socialization is amendable to intervention and results in improved child and parent outcomes. However, no studies have investigated the emotion socialization practices utilized by parents of children with FASD or whether interventions targeting parent emotion socialization result in improved child emotion regulation and behavior in this population.

This study will address this critical gap by initiating an empirical test of a promising emotion-focused intervention, Tuning In To Kids (TIK), with families raising children with FASD. Results from this initial efficacy trial will determine whether parent emotion socialization is a promising intervention target for this population. Consistent with a developmental psychopathology perspective, multi-level data from the efficacy trial will be leveraged to test theorized associations between parent emotion socialization and child emotion regulation and identify possible factors contributing to individual differences. These results will inform possible intervention adaptations for this population and provide the necessary foundation for larger-scale efficacy trials. The long-term goals of this research are to better understand the complex factors influencing emotion regulation in children with FASD and improve mental health interventions and outcomes for this population.

Eligibility 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

Primary outcomes:
measure: Parent Awareness of Own Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Parent Acceptance of Own Expression Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Parent Regulation of Own Emotions Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Parent Awareness of Child Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Parent Acceptance of Child's Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Parent Emotion Coaching Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Child Regulation Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Parent Awareness of Own Emotion Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Parent Acceptance of Own Expression Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Parent Regulation of Own Emotions Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Parent Awareness of Child Emotion Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Parent Acceptance of Child's Emotion Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Parent Emotion Coaching Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Child Regulation Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to post-intervention (8 weeks)
measure: Proportion of Observed Emotion Coaching Statements Using the Family Narrative Task at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Proportion of Observed Emotion Dismissing Statements Using the Family Narrative Task at Baseline and Immediate Post-intervention (8 Weeks)
timeFrame: baseline to immediate post-intervention (8 weeks)
measure: Child Emotion Regulation Using the Emotion Regulation Checklist at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up
timeFrame: baseline, immediate post-intervention (8 weeks), 3-month post-intervention follow-up
measure: Child Lability/Negativity Using the Emotion Regulation Checklist at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up
timeFrame: baseline, immediate post-intervention (8 weeks), 3-month post-intervention follow-up
measure: Intensity of Disruptive Behaviors Using the Eyberg Child Behavior Inventory at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up
timeFrame: baseline, immediate post-intervention (8 weeks), 3-month post-intervention follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mt. Hope Family Center
state: New York
Study officials:
References: