Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
1 other identifier
interventional
65
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 19, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2015
CompletedMay 29, 2015
May 1, 2015
2.7 years
November 19, 2014
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Emotion regulation
Evaluated by parent questionnaires
14 weeks after initial testing
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
Alert Program for Self-Regulation
EXPERIMENTALParticipants with FASD who received the Alert Program for Self-Regulation therapy between the two testing periods.
FASD Alert Waitlist
NO INTERVENTIONParticipants with FASD who did not receive therapy between the two testing periods but were provided intervention on study completion.
Typically Developing Control
NO INTERVENTIONNormally developing controls not exposed to alcohol in utero who were not treated between the two testing periods.
Interventions
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.
Eligibility Criteria
You may qualify if:
- FASD: diagnosis of FAS/pFAS or ARND OR
- healthy child
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 25788884RESULTNash 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.
PMID: 25010354RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne Rovet, PhD
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
November 19, 2014
First Posted
May 29, 2015
Study Start
October 1, 2009
Primary Completion
June 1, 2012
Last Updated
May 29, 2015
Record last verified: 2015-05