Clinical trial NCT02457676: Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
Official title: Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Keywords: Self-Regulation Training
Neuroimaging
Response Inhibition
Behavioral Regulation
Emotional Regulation
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-05-29
Enrollment: 65
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Emotion regulation
timeFrame: 14 weeks after initial testing
Secondary outcomes:
measure: Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF
timeFrame: 14 weeks after initial testing
measure: Social cognition: Saltzman's Social Cognitive Task; NEPSY
timeFrame: 14 weeks after initial testing
measure: Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist
timeFrame: 14 weeks after initial testing
measure: Brain structure: Voxel-based morphometry
timeFrame: 14 weeks after initial testing
measure: Brain structure: Cortical thickness
timeFrame: 14 weeks after initial testing
measure: Brain function: Functional MRI
timeFrame: 14 weeks after initial testing
Other outcomes:
Locations:
Study officials:
affiliation: The Hospital for Sick Children
name: Joanne Rovet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soh DW, Skocic J, Nash K, Stevens S, Turner GR, Rovet J. Self-regulation therapy increases frontal gray matter in children with fetal alcohol spectrum disorder: evaluation by voxel-based morphometry. Front Hum Neurosci. 2015 Mar 4;9:108. doi: 10.3389/fnhum.2015.00108. eCollection 2015.
citation: Nash K, Stevens S, Greenbaum R, Weiner J, Koren G, Rovet J. Improving executive functioning in children with fetal alcohol spectrum disorders. Child Neuropsychol. 2015;21(2):191-209. doi: 10.1080/09297049.2014.889110. Epub 2014 Jul 10.