Trial Outcomes & Findings for A Study of Parent and Child Emotions in Fetal Alcohol Spectrum Disorder (FASD) (NCT NCT03524664)

Families were primarily recruited from a University Medical Center Diagnostic Clinic for fetal alcohol spectrum disorders. Providers gave potentially eligible families a flyer about the study. Families then contacted the study team to complete screening over the phone.

118 families were screened for eligibility. A total of 2 has incomplete screening, 10 were excluded for not meeting inclusion criteria, 4 declined to participate, 13 were not able to schedule baseline assessments, and 2 withdrew or were lost to contact after baseline assessments, but before randomization. A total of 87 families were randomized to study arm.

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

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 emotions. The parent awareness sub-scale for sadness includes 9 items; sub-scale score is a sum of items with a total range of 9 to 45. A higher score reflects greater parental awareness of their sadness.

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 emotions. The parent acceptance of expressivity sub-scale for sadness includes 8 items; sub-scale score is a sum of items with a total range of 8 to 40. A higher score reflects greater acceptance of emotion expression for sadness.

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 emotions. The parent sub-scale for regulation of their own sadness includes 6 items; sub-scale score is a sum of items with a total range of 6 to 30. A higher score reflects better parent regulation of their sadness.

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 emotions. The parent awareness of child's sadness sub-scale includes 8 items; sub-scale score is a sum of items with a total range of 8 to 40. A higher score reflects greater parental awareness of their child's sadness.

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 emotions. The parent acceptance of their child's sadness sub-scale includes 6 items; sub-scale score is a sum of items with a total range of 6 to 30. A higher score reflects greater acceptance of their child's sadness.

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 emotions. The parent emotion coaching sub-scale for sadness includes 6 items; sub-scale score is a sum of items with a total range of 6 to 30. A higher score reflects greater use of emotion coaching when their child is sad.

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 emotions. The child regulation sub-scale for sadness includes 7 items; sub-scale score is a sum of items with a total range of 7 to 35. A higher score reflects better child regulation of sadness.

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 emotions. The parent awareness sub-scale for anger includes 9 items; sub-scale score is a sum of items with a total range of 9 to 45. A higher score reflects greater parental awareness of their own anger.

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 emotions. The parent acceptance of their anger expression sub-scale includes 8 items; sub-scale score is a sum of items with a total range of 8 to 40. A higher score reflects greater parental acceptance of their own anger expression.

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 emotions. The parent regulation sub-scale for anger includes 6 items; sub-scale score is a sum of items with a total range of 6 to 30. A higher score reflects better parental regulation of their own anger.

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 emotions. The parent awareness of their child's anger sub-scale includes 8 items; sub-scale score is a sum of items with a total range of 8 to 40. A higher score reflects greater awareness of their child's anger.

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 emotions. The parent acceptance of their child's anger sub-scale includes 6 items; sub-scale score is a sum of items with a total range of 6 to 30. A higher score reflects greater parental acceptance of their child's anger.

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 emotions. The parent emotion coaching sub-scale for anger includes 6 items; sub-scale score is a sum of items with a total range of 6 to 30. A higher score reflects greater use of emotion coaching of the child's anger.

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 emotions. The child regulation sub-scale for anger includes 7 items; sub-scale score is a sum of items with a total range of 7 to 35. A higher score reflects better child emotion regulation.

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) is coded. The proportion of emotion coaching statements across all three scenarios made versus total statements is calculated. Higher scores reflect greater proportion of emotion coaching statements made.

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) is coded. The proportion of emotion dismissing statements across all three scenarios versus total statements is calculated, with higher proportions reflecting more use of emotion dismissing statements.

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. Items are summed for each sub-scale. For the emotion regulation sub-scale the score ranges from 12-48 with higher scores reflecting better emotion regulation.

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. Item scores are summed for each sub-scale. For the lability/negativity sub-scale, the score ranges from 12-48 with higher scores reflecting worse lability/negativity.

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 standardized score with a "T-score" with mean of 50 and standard deviation of 10. Higher scores reflecting more problems. This is given at baseline, immediate post-intervention (8 weeks) and 3-month post-intervention follow-up. Scores are considered clinically elevated when T\>60.