Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention

Study Overview
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Brief Summary
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This study on children with fetal alcohol spectrum disorder (FASD) aims to (i) characterize their self-regulation deficits, a process important for controlling emotions and behavior, (ii) describe brain structure and function underlying self-regulation, and (iii) determine whether training to improve self-regulation abilities changes brain and behavior. Individuals with FASD have a high risk of cognitive and social deficits, which reflect their difficulties in self-regulation and may lead to mental health concerns in adulthood. Importantly, early intervention improves long-term outcome. However the full extent of self-regulation problems in FASDs is unknown and the underlying neuroanatomy has not been fully described. Furthermore, information on how to best treat children with FASDs is lacking. Thus, the investigators propose three studies with a sample of 8-12 year old children, 40 with FASDs and 20 typically developing controls. In Study 1, the participants will be evaluated on cognitive and social self-regulation abilities using clinical and experimental tests. In Study 2, the participants will undergo a 1-hour MRI scanning session to obtain measures of their brain structure and function. In Study 3, FASDs will be randomly assigned to an immediate or delayed treatment group. The immediate group will undergo 12-weeks of therapy with the Alert Program for Self Regulation®. On conclusion of training, all will repeat Studies 1 and 2 and following this retest, the delayed treatment group will undergo training. The investigators will evaluate change in cognitive and social behavior and in brain structure and function by comparing performance and neuroimaging findings before and after the intervention. The investigators expect Alert training to significantly improve behavior and alter brain regions important for self-regulation. The findings will yield important information for improving self-regulation in FASDs and mitigating the development of mental health challenges.

Official Title
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Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention

Conditions
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Fetal Alcohol Spectrum Disorders

Intervention / Treatment
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* Behavioral: Alert Program for Self-Regulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FASD: diagnosis of FAS/pFAS or ARND OR healthy child Exclusion Criteria: head injury or other neurological abnormality debilitating or chronic medical condition affecting the nervous system MRI contraindication, such as braces inability to read non-English speaking IQ below 80 (typically developing controls only)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alert Program for Self-Regulation<br>Participants with FASD who received the Alert Program for Self-Regulation therapy between the two testing periods. | Behavioral: Alert Program for Self-Regulation<br>* Children attend 12 1.5 hour weekly sessions. Alert uses the analogy of a car engine to help children identify their own self-regulatory behavior. Children learn strategies to regulate their own engine speed in different situations.<br>|
| No Intervention: FASD Alert Waitlist<br>Participants with FASD who did not receive therapy between the two testing periods but were provided intervention on study completion. | |
| No Intervention: Typically Developing Control<br>Normally developing controls not exposed to alcohol in utero who were not treated between the two testing periods. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion regulation | Evaluated by parent questionnaires | 14 weeks after initial testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF | Evaluated by neuropsychological tests | 14 weeks after initial testing | 
| Social cognition: Saltzman's Social Cognitive Task; NEPSY | Evaluated by neuropsychological tests | 14 weeks after initial testing | 
| Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist | Evaluated by parent questionnaires | 14 weeks after initial testing | 
| Brain structure: Voxel-based morphometry | Voxel-based morphometry analyses | 14 weeks after initial testing | 
| Brain structure: Cortical thickness | Civet pipeline | 14 weeks after initial testing | 
| Brain function: Functional MRI | Response inhibition paradigm | 14 weeks after initial testing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-Regulation Training, Neuroimaging, Response Inhibition, Behavioral Regulation, Emotional Regulation