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Trial record 2 of 36 for:    fetal alcohol children

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

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ClinicalTrials.gov Identifier: NCT02457676
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : May 29, 2015
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Joanne Rovet, 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.

Condition or disease Intervention/treatment Phase
Fetal Alcohol Spectrum Disorders Behavioral: Alert Program for Self-Regulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
Study Start Date : October 2009
Actual Primary Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alert Program for Self-Regulation
Participants with FASD who received the Alert Program for Self-Regulation therapy between the two testing periods.
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.

No Intervention: FASD Alert Waitlist
Participants with FASD who did not receive therapy between the two testing periods but were provided intervention on study completion.
No Intervention: Typically Developing Control
Normally developing controls not exposed to alcohol in utero who were not treated between the two testing periods.



Primary Outcome Measures :
  1. Emotion regulation [ Time Frame: 14 weeks after initial testing ]
    Evaluated by parent questionnaires


Secondary Outcome Measures :
  1. Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF [ Time Frame: 14 weeks after initial testing ]
    Evaluated by neuropsychological tests

  2. Social cognition: Saltzman's Social Cognitive Task; NEPSY [ Time Frame: 14 weeks after initial testing ]
    Evaluated by neuropsychological tests

  3. Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist [ Time Frame: 14 weeks after initial testing ]
    Evaluated by parent questionnaires

  4. Brain structure: Voxel-based morphometry [ Time Frame: 14 weeks after initial testing ]
    Voxel-based morphometry analyses

  5. Brain structure: Cortical thickness [ Time Frame: 14 weeks after initial testing ]
    Civet pipeline

  6. Brain function: Functional MRI [ Time Frame: 14 weeks after initial testing ]
    Response inhibition paradigm



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457676


Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Joanne Rovet, PhD The Hospital for Sick Children

Publications of Results:
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Responsible Party: Joanne Rovet, Senior Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02457676     History of Changes
Other Study ID Numbers: 1000014076
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Joanne Rovet, The Hospital for Sick Children:
Self-Regulation Training
Neuroimaging
Response Inhibition
Behavioral Regulation
Emotional Regulation

Additional relevant MeSH terms:
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Disease
Fetal Alcohol Spectrum Disorders
Pathologic Processes
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders