Fetal Alcohol Spectrum DisordersNCT03524664
A Study of Parent and Child Emotions in Fetal Alcohol Spectrum Disorder (FASD)
A study testing Tuning In to kids intervention in people with Fetal Alcohol Spectrum Disorders, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Tuning In to kids intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parent Emotion Socialization and Child Emotion Regulation in FASD
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:
Read more
- 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
Read the 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.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Tuning In to kids intervention
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuning In to kids interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Tuning In to kids intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, immediate post-intervention (8 weeks), 3-month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start13 Aug 2018
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Christie Petrenko, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524664
- Sponsor's protocol ID
- RSRB69545
- Other IDs
- R34AA025717
- Status last verified
- Oct 2022
- First submitted
- 2 May 2018
- Last updated
- 4 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40884006
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Emotion Socialization and Child Emotion Regulation in FASD
- ClinicalTrials.gov ID
- NCT03524664
- Acronym / sponsor ID
- RSRB69545
- Conditions
- Fetal Alcohol Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Posted 4 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed "tuning in to kids" intervention | No intervention | –Children with fetal alcohol spectrum disorder and their parents |
| "Tuning in to kids" intervention | Experimental | Behavioral: Tuning In to kids interventionChildren with fetal alcohol spectrum disorder and their parents |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuning In to kids interventionThe 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. | Behavioural | "Tuning in to kids" intervention |
Primary outcome
Parent Awareness of Own Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Parent Acceptance of Own Expression Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Parent Regulation of Own Emotions Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Parent Awareness of Child Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Parent Acceptance of Child's Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Parent Emotion Coaching Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Child Regulation Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Parent Awareness of Own Emotion Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Parent Acceptance of Own Expression Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Parent Regulation of Own Emotions Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Parent Awareness of Child Emotion Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Parent Acceptance of Child's Emotion Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Parent Emotion Coaching Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Child Regulation Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Proportion of Observed Emotion Coaching Statements Using the Family Narrative Task at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Proportion of Observed Emotion Dismissing Statements Using the Family Narrative Task at Baseline and Immediate Post-intervention (8 Weeks)
Time frame: baseline to 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.
Child Emotion Regulation Using the Emotion Regulation Checklist at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up
Time frame: baseline, immediate post-intervention (8 weeks), 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.
Child Lability/Negativity Using the Emotion Regulation Checklist at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up
Time frame: baseline, immediate post-intervention (8 weeks), 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.
Intensity of Disruptive Behaviors Using the Eyberg Child Behavior Inventory at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up
Time frame: baseline, immediate post-intervention (8 weeks), 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40884006Petrenko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuning In to kids intervention in people with Fetal Alcohol Spectrum Disorders, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Awareness of Own Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks) (time frame: baseline to immediate post-intervention (8 weeks)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.