Self-Regulation in Adolescents With FASD: The Efficacy of a Targeted Intervention

Summary

Fetal alcohol spectrum disorder (FASD) describes a collection of physical, mental, and behavioral disabilities that result from prenatal alcohol exposure (PAE). Individuals with FASD often struggle with self-regulation, or the ability to control thoughts, emotions and actions, which can lead to many long-term problematic life circumstances.

This study aims to improve self-regulation abilities in adolescents, aged 11-17, with FASD using a targeted intervention. Researchers adapted the Alert Program®, a developed intervention targeting self-regulation in children, to be appropriate for an adolescent FASD population. Participants are split into two groups: an FASD intervention group, and an FASD waitlist group. These groups are compared on a variety of measures. These measures include cognitive measures (executive functioning, response conflict, inhibitory control, etc), behavioural measures (self-regulation, adaptive behaviour, etc), and physiological measures (cortisol and sleep). The FASD intervention group will be tested at baseline and once after the intervention, and lastly after an approximately 12-week wait following the intervention. The FASD waitlist group will be tested at baseline, after a three month wait period, and again after receiving the intervention.

The investigators expect that the Alert program® will lead to significant improvements in participant's self-regulation abilities as evidenced by cognitive, behavioural, and physiological changes. Improving self-regulation in adolescents with FASD will reduce the high level of adverse outcomes experienced by adolescents with FASD, and help them have a successful transition into adulthood.

Conditions

• Self-regulation
• Adolescents
• Fetal Alcohol Spectrum Disorder

Interventions

BEHAVIORAL

Self-Regulation Intervention adapted from the Alert Program ®

Sponsors & Collaborators

• Glenrose Foundation

  collaborator OTHER

• Woman and Children's Health Research Institute

  collaborator UNKNOWN

• NeuroDevNet

  collaborator OTHER

• Provincial Health Services Authority

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• University of Alberta

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2018-05-31

Completion

2018-08-31

Countries

• Canada

Study Locations