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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA025717 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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:
Caregivers will be asked to complete interviews and questionnaires about:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed "tuning in to kids" intervention | No Intervention | Children with fetal alcohol spectrum disorder and their parents | |
| "Tuning in to kids" intervention | Experimental | Children with fetal alcohol spectrum disorder and their parents |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tuning In to kids intervention | Behavioral | The Tuning Into Kids Program involves:
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| Measure | Description | Time Frame |
|---|---|---|
| Parent Awareness of Own Emotion Score for Sadness at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Parent Acceptance of Own Expression Score for Sadness at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Parent Regulation of Own Emotions Score for Sadness at Baseline and Immediate Post-intervention (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 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. |
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Inclusion Criteria:
Families will be eligible for the study if they:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mt. Hope Family Center | Rochester | New York | 14608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40884006 | Derived | Petrenko CLM, Kautz-Turnbull C, Rockhold MN, Handley ED, Havighurst SS, Toth SL. Results of a pilot randomized controlled trial of Tuning in to Kids for children with FASD in nonbiological parent care. Alcohol Clin Exp Res (Hoboken). 2025 Oct;49(10):2349-2364. doi: 10.1111/acer.70153. Epub 2025 Aug 29. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delayed "Tuning in to Kids" Intervention | Children with fetal alcohol spectrum disorder and their parents Received the Tuning in to Kids intervention about 5-6 months after randomization. |
| FG001 | "Tuning in to Kids" Intervention | Children with fetal alcohol spectrum disorder and their parents Tuning In to kids intervention: The Tuning Into Kids Program involves:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Delayed "Tuning in to Kids" Intervention | Children with fetal alcohol spectrum disorder and their parents Received the Tuning in to Kids intervention about 5-6 months after randomization. |
| BG001 | "Tuning in to Kids" Intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Parent age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parent Awareness of Own Emotion Score for Sadness at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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Baseline, immediate post-intervention (8 weeks), and 3-month post-intervention follow-up.
Adverse events in children with FASD or their caregivers could include aggression or violence towards others, maltreatment, self-harm or suicidality, or the need for inpatient hospitalization. However, these occurrences are unlikely to be a direct consequence of participation in the caregiver intervention or study. These were not systematically assessed but procedures were in place to assess risk and respond appropriately if they arose. No adverse events were detected or reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delayed "Tuning in to Kids" Intervention | Children with fetal alcohol spectrum disorder and their parents Received the Tuning in to Kids intervention about 5-6 months after randomization. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christie Petrenko | Mt. Hope Family Center, University of Rochester | (585) 275-2991 | 241 | christie_petrenko@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2020 | Aug 31, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Caregiver Consent Form | Sep 18, 2020 | Aug 31, 2022 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Permission Form (child in foster care) | Sep 18, 2020 | Aug 31, 2022 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Child Assent | Sep 18, 2020 | Aug 31, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| baseline to immediate post-intervention (8 weeks) |
| Parent Awareness of Child Emotion Score for Sadness at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Parent Acceptance of Child's Emotion Score for Sadness at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Parent Emotion Coaching Score for Sadness at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Child Regulation Score for Sadness at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Parent Awareness of Own Emotion Score for Anger at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Parent Acceptance of Own Expression Score for Anger at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Parent Regulation of Own Emotions Score for Anger at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Parent Awareness of Child Emotion Score for Anger at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Parent Acceptance of Child's Emotion Score for Anger at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Parent Emotion Coaching Score for Anger at Baseline and Immediate Post-intervention (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 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. | baseline to immediate post-intervention (8 weeks) |
| Child Regulation Score for Anger at Baseline and Immediate Post-intervention (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 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. | baseline to post-intervention (8 weeks) |
| Proportion of Observed Emotion Coaching Statements Using the Family Narrative Task at Baseline and Immediate Post-intervention (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) 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. | baseline to immediate post-intervention (8 weeks) |
| Proportion of Observed Emotion Dismissing Statements Using the Family Narrative Task at Baseline and Immediate Post-intervention (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) 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. | baseline to immediate post-intervention (8 weeks) |
| Child Emotion Regulation Using the Emotion Regulation Checklist at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up | 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. | baseline, immediate post-intervention (8 weeks), 3-month post-intervention follow-up |
| Child Lability/Negativity Using the Emotion Regulation Checklist at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up | 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. | baseline, immediate post-intervention (8 weeks), 3-month post-intervention follow-up |
| Intensity of Disruptive Behaviors Using the Eyberg Child Behavior Inventory at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up | 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. | baseline, immediate post-intervention (8 weeks), 3-month post-intervention follow-up |
Children with fetal alcohol spectrum disorder and their parents
Tuning In to kids intervention: The Tuning Into Kids Program involves:
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
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| Sex: Female, Male | Caregiver Sex | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Caregiver Ethnicity | Count of Participants | Participants |
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| Race (NIH/OMB) | Caregiver Race | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Child Age | Mean | Standard Deviation | years |
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| Child Sex at Birth | Count of Participants | Participants |
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| Child Race | Count of Participants | Participants |
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| Child Ethnicity | Count of Participants | Participants |
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Children with fetal alcohol spectrum disorder and their parents Received the Tuning in to Kids intervention about 5-6 months after randomization. |
| OG001 | "Tuning in to Kids" Intervention | Children with fetal alcohol spectrum disorder and their parents Tuning In to kids intervention: The Tuning Into Kids Program involves:
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| Primary | Parent Acceptance of Own Expression Score for Sadness at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Parent Regulation of Own Emotions Score for Sadness at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Parent Awareness of Child Emotion Score for Sadness at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Parent Acceptance of Child's Emotion Score for Sadness at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Parent Emotion Coaching Score for Sadness at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Child Regulation Score for Sadness at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Parent Awareness of Own Emotion Score for Anger at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Parent Acceptance of Own Expression Score for Anger at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Parent Regulation of Own Emotions Score for Anger at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Parent Awareness of Child Emotion Score for Anger at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Parent Acceptance of Child's Emotion Score for Anger at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Parent Emotion Coaching Score for Anger at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to immediate post-intervention (8 weeks) |
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| Primary | Child Regulation Score for Anger at Baseline and Immediate Post-intervention (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 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. | Outcome data analyzed for those with complete data at both timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to post-intervention (8 weeks) |
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| Primary | Proportion of Observed Emotion Coaching Statements Using the Family Narrative Task at Baseline and Immediate Post-intervention (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) 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. | Outcome data analyzed for those with complete data at all timepoints. During the COVID-19 pandemic, interview measures were completed over Zoom with research staff, whereas questionnaires were sent electronically to families to complete. Completion rate of questionnaires and observational tasks was lower. | Posted | Mean | Standard Error | proportion of statements | baseline to immediate post-intervention (8 weeks) |
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| Primary | Proportion of Observed Emotion Dismissing Statements Using the Family Narrative Task at Baseline and Immediate Post-intervention (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) 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. | Outcome data analyzed for those with complete data at all timepoints. During the COVID-19 pandemic, interview measures were completed over Zoom with research staff, whereas questionnaires were sent electronically to families to complete. Completion rate of observation tasks and questionnaires was lower. | Posted | Mean | Standard Error | proportion of statements | baseline to immediate post-intervention (8 weeks) |
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| Primary | Child Emotion Regulation Using the Emotion Regulation Checklist at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up | 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. | Outcome data analyzed for those with complete data at all timepoints. During the COVID-19 pandemic, interview measures were completed over Zoom with research staff, whereas questionnaires were sent electronically to families to complete. Completion rate of questionnaires was lower. | Posted | Mean | Standard Error | score on a scale | baseline, immediate post-intervention (8 weeks), 3-month post-intervention follow-up |
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| Primary | Child Lability/Negativity Using the Emotion Regulation Checklist at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up | 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. | Outcome data analyzed for those with complete data at all timepoints. During the COVID-19 pandemic, interview measures were completed over Zoom with research staff, whereas questionnaires were sent electronically to families to complete. Completion rate of questionnaires was lower. | Posted | Mean | Standard Error | score on a scale | baseline, immediate post-intervention (8 weeks), 3-month post-intervention follow-up |
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| Primary | Intensity of Disruptive Behaviors Using the Eyberg Child Behavior Inventory at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up | 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. | Outcome data analyzed for those with complete data at all timepoints. During the COVID-19 pandemic, interview measures were completed over Zoom with research staff, whereas questionnaires were sent electronically to families to complete. Completion rate of questionnaires was lower. | Posted | Mean | Standard Error | T-score | baseline, immediate post-intervention (8 weeks), 3-month post-intervention follow-up |
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| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | "Tuning in to Kids" Intervention | Children with fetal alcohol spectrum disorder and their parents Tuning In to kids intervention: The Tuning Into Kids Program involves:
| 0 | 54 | 0 | 54 | 0 | 54 |
Not provided
Not provided
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| Three-Months Post-Intervention (T3) |
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| Three-Month post-Intervention (T3) |
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| Three-Month Post-Intervention (T3) |
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