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

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457676
• Other study ID #: 1000014076
• Status: Completed
• Phase: N/A
• First received: November 19, 2014
• Last updated: May 26, 2015
• Start date: October 2009

Study information

• Verified date: May 2015
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders

Intervention

Behavioral:
• Alert Program for Self-Regulation
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR)

References & Publications (2)

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. — View 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/fnhu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotion regulation	Evaluated by parent questionnaires	14 weeks after initial testing	No
Secondary	Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF	Evaluated by neuropsychological tests	14 weeks after initial testing	No
Secondary	Social cognition: Saltzman's Social Cognitive Task; NEPSY	Evaluated by neuropsychological tests	14 weeks after initial testing	No
Secondary	Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist	Evaluated by parent questionnaires	14 weeks after initial testing	No
Secondary	Brain structure: Voxel-based morphometry	Voxel-based morphometry analyses	14 weeks after initial testing	No
Secondary	Brain structure: Cortical thickness	Civet pipeline	14 weeks after initial testing	No
Secondary	Brain function: Functional MRI	Response inhibition paradigm	14 weeks after initial testing	No