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

T

The Hospital for Sick Children

Status

Completed

Conditions

Fetal Alcohol Spectrum Disorders

Treatments

Behavioral: Alert Program for Self-Regulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02457676
1000014076

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

8 to 12 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65 participants in 3 patient groups

Alert Program for Self-Regulation
Experimental group
Description:
Participants with FASD who received the Alert Program for Self-Regulation therapy between the two testing periods.
Treatment:
Behavioral: Alert Program for Self-Regulation
FASD Alert Waitlist
No Intervention group
Description:
Participants with FASD who did not receive therapy between the two testing periods but were provided intervention on study completion.
Typically Developing Control
No Intervention group
Description:
Normally developing controls not exposed to alcohol in utero who were not treated between the two testing periods.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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