MedTrace Logo

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

NCT02457676 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2015-05-29

No results posted yet for this study

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.

Conditions

  • Fetal Alcohol Spectrum Disorders

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Joanne Rovet, PhD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02457676 on ClinicalTrials.gov