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

NCT ID: NCT02457676

Last Updated: 2015-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31

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.

Conditions

Fetal Alcohol Spectrum Disorders

Keywords

Self-Regulation Training; Neuroimaging; Response Inhibition; Behavioral Regulation; Emotional Regulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alert Program for Self-Regulation

Participants with FASD who received the Alert Program for Self-Regulation therapy between the two testing periods.

Group Type: EXPERIMENTAL

Alert Program for Self-Regulation

Intervention Type: BEHAVIORAL

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.

FASD Alert Waitlist

Participants with FASD who did not receive therapy between the two testing periods but were provided intervention on study completion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Typically Developing Control

Normally developing controls not exposed to alcohol in utero who were not treated between the two testing periods.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Joanne Rovet

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joanne Rovet, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

References

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.

Reference Type: RESULT

PMID: 25788884 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25010354 (View on PubMed)

Other Identifiers

1000014076

Identifier Type: -

Identifier Source: org_study_id