Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
- Conditions
- Fetal Alcohol Spectrum Disorders
- Interventions
- Behavioral: Alert Program for Self-Regulation
- Registration Number
- NCT02457676
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- FASD: diagnosis of FAS/pFAS or ARND OR
- healthy child
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alert Program for Self-Regulation Alert Program for Self-Regulation Participants with FASD who received the Alert Program for Self-Regulation therapy between the two testing periods.
- Primary Outcome Measures
Name Time Method Emotion regulation 14 weeks after initial testing Evaluated by parent questionnaires
- Secondary Outcome Measures
Name Time Method Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF 14 weeks after initial testing Evaluated by neuropsychological tests
Social cognition: Saltzman's Social Cognitive Task; NEPSY 14 weeks after initial testing Evaluated by neuropsychological tests
Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist 14 weeks after initial testing Evaluated by parent questionnaires
Brain structure: Voxel-based morphometry 14 weeks after initial testing Voxel-based morphometry analyses
Brain structure: Cortical thickness 14 weeks after initial testing Civet pipeline
Brain function: Functional MRI 14 weeks after initial testing Response inhibition paradigm