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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
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

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

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 19, 2014
    Last Updated
    May 26, 2015
    Sponsor
    The Hospital for Sick Children
    Collaborators
    Canadian Institutes of Health Research (CIHR)
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    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

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

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