Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
Primary Purpose
Fetal Alcohol Spectrum Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alert Program for Self-Regulation
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders focused on measuring Self-Regulation Training, Neuroimaging, Response Inhibition, Behavioral Regulation, Emotional Regulation
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Alert Program for Self-Regulation
FASD Alert Waitlist
Typically Developing Control
Arm Description
Participants with FASD who received the Alert Program for Self-Regulation therapy between the two testing periods.
Participants with FASD who did not receive therapy between the two testing periods but were provided intervention on study completion.
Normally developing controls not exposed to alcohol in utero who were not treated between the two testing periods.
Outcomes
Primary Outcome Measures
Emotion regulation
Evaluated by parent questionnaires
Secondary Outcome Measures
Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF
Evaluated by neuropsychological tests
Social cognition: Saltzman's Social Cognitive Task; NEPSY
Evaluated by neuropsychological tests
Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist
Evaluated by parent questionnaires
Brain structure: Voxel-based morphometry
Voxel-based morphometry analyses
Brain structure: Cortical thickness
Civet pipeline
Brain function: Functional MRI
Response inhibition paradigm
Full Information
NCT ID
NCT02457676
First Posted
November 19, 2014
Last Updated
May 26, 2015
Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT02457676
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders
Keywords
Self-Regulation Training, Neuroimaging, Response Inhibition, Behavioral Regulation, Emotional Regulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alert Program for Self-Regulation
Arm Type
Experimental
Arm Description
Participants with FASD who received the Alert Program for Self-Regulation therapy between the two testing periods.
Arm Title
FASD Alert Waitlist
Arm Type
No Intervention
Arm Description
Participants with FASD who did not receive therapy between the two testing periods but were provided intervention on study completion.
Arm Title
Typically Developing Control
Arm Type
No Intervention
Arm Description
Normally developing controls not exposed to alcohol in utero who were not treated between the two testing periods.
Intervention Type
Behavioral
Intervention Name(s)
Alert Program for Self-Regulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Emotion regulation
Description
Evaluated by parent questionnaires
Time Frame
14 weeks after initial testing
Secondary Outcome Measure Information:
Title
Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF
Description
Evaluated by neuropsychological tests
Time Frame
14 weeks after initial testing
Title
Social cognition: Saltzman's Social Cognitive Task; NEPSY
Description
Evaluated by neuropsychological tests
Time Frame
14 weeks after initial testing
Title
Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist
Description
Evaluated by parent questionnaires
Time Frame
14 weeks after initial testing
Title
Brain structure: Voxel-based morphometry
Description
Voxel-based morphometry analyses
Time Frame
14 weeks after initial testing
Title
Brain structure: Cortical thickness
Description
Civet pipeline
Time Frame
14 weeks after initial testing
Title
Brain function: Functional MRI
Description
Response inhibition paradigm
Time Frame
14 weeks after initial testing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Rovet, PhD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
25788884
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.
Results Reference
result
PubMed Identifier
25010354
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.
Results Reference
result
Learn more about this trial
Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
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