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

May 26, 2015 updated by: Joanne Rovet, The Hospital for Sick Children
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion regulation
Time Frame: 14 weeks after initial testing
Evaluated by parent questionnaires
14 weeks after initial testing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF
Time Frame: 14 weeks after initial testing
Evaluated by neuropsychological tests
14 weeks after initial testing
Social cognition: Saltzman's Social Cognitive Task; NEPSY
Time Frame: 14 weeks after initial testing
Evaluated by neuropsychological tests
14 weeks after initial testing
Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist
Time Frame: 14 weeks after initial testing
Evaluated by parent questionnaires
14 weeks after initial testing
Brain structure: Voxel-based morphometry
Time Frame: 14 weeks after initial testing
Voxel-based morphometry analyses
14 weeks after initial testing
Brain structure: Cortical thickness
Time Frame: 14 weeks after initial testing
Civet pipeline
14 weeks after initial testing
Brain function: Functional MRI
Time Frame: 14 weeks after initial testing
Response inhibition paradigm
14 weeks after initial testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Joanne Rovet, PhD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

May 26, 2015

First Posted (ESTIMATE)

May 29, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000014076

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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