A Study of Parent and Child Emotions in Fetal Alcohol Spectrum Disorder (FASD)
Condition: Fetal Alcohol Spectrum Disorders
MeSH terms: Fetal Alcohol Spectrum Disorders
Study type: Interventional

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.
    

Intervention name(s): Tuning In to kids intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment