Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 65
- Primary Endpoint
- Emotion regulation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Alert Program for Self-Regulation
Participants with FASD who received the Alert Program for Self-Regulation therapy between the two testing periods.
Intervention: Alert Program for Self-Regulation (Behavioral)
FASD Alert Waitlist
Participants with FASD who did not receive therapy between the two testing periods but were provided intervention on study completion.
Typically Developing Control
Normally developing controls not exposed to alcohol in utero who were not treated between the two testing periods.
Outcomes
Primary Outcomes
Emotion regulation
Time Frame: 14 weeks after initial testing
Evaluated by parent questionnaires
Secondary Outcomes
- Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF(14 weeks after initial testing)
- Social cognition: Saltzman's Social Cognitive Task; NEPSY(14 weeks after initial testing)
- Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist(14 weeks after initial testing)
- Brain structure: Voxel-based morphometry(14 weeks after initial testing)
- Brain structure: Cortical thickness(14 weeks after initial testing)
- Brain function: Functional MRI(14 weeks after initial testing)
Investigators
Joanne Rovet
Senior Scientist
The Hospital for Sick Children