Self-Regulation in Adolescents With FASD: The Efficacy of a Targeted Intervention
Condition: Self-regulation; Adolescents; Fetal Alcohol Spectrum Disorder
MeSH terms: Fetal Alcohol Spectrum Disorders
Study type: Interventional

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.
    

Detailed description: 
      Objectives:

      The goal of the proposed research is to determine if adolescents with Fetal Alcohol Spectrum
      Disorder (FASD) will have improvements in their ability to self-regulate after the
      implementation of a targeted intervention. The project is part of the larger NeuroDevNet
      renewal grant. The goals of the proposed project are to study adolescents with FASD to
      examine: 1) the association of measures of Executive Function (EF) and self-regulation with
      life adversities and adverse outcomes 2) cortisol regulation in FASD and its association with
      life adversity and difficulties with EF, self-regulation, sleep, and adverse outcomes 3)
      whether EF, self-regulation, sleep, and cortisol regulation can be improved with an
      intervention targeting self-regulation.

      Research questions:

      Can self-regulation among adolescents with FASD be improved with a targeted intervention? The
      investigators hypothesize that the participants with FASD in the modified Alert Program ®
      intervention will have greater improvements on cognitive, behavioral, and physiological
      measures of self-regulation compared to the wait-list control group.

        1. How is self-regulation impacted in adolescents with FASD? The investigators hypothesize
           that adolescents with FASD will have significantly lower scores (at baseline) on a
           variety of measures of self-regulation including cognitive, behavioral, and
           physiological measures (cortisol regulation and sleep behaviors) compared to normative
           samples. This information is important for informing the profile of self-regulation
           impairments in FASD.

        2. Do improvements in self-regulation lead to improvements in functional outcomes of
           adolescents with FASD? The investigators hypothesize that following the intervention,
           participants with FASD will show improvements in reported functional outcomes on a
           measures adaptive functioning.

      Background:

      Individuals with FASD display significant executive functioning (EF) impairments (e.g.,
      inhibition, decision making, thinking flexibly) as well as difficulties in regulating their
      behavior. They are at risk for early life adversities (e.g., unstable home environment) and
      adverse outcomes including mental health issues, delinquency, and substance abuse. Adverse
      outcomes in FASD may result from EF and self-regulation impairments that have the potential
      to be mitigated with targeted interventions. Altered hypothalamic-pituitary-adrenal (HPA)
      activity, as indexed by plasma cortisol levels, is a physiological marker of self-regulation.
      Importantly, PAE is known to affect HPA activity and regulation. Sleep behaviors are also
      disrupted in FASD, which is another physiological marker of self-regulation.

      Recognizing the profile of self-regulation deficits in FASD, and the functional outcomes of
      such impairments will equip the investigators to examine the impact of intervention efforts
      on self-regulation. Research on the efficacy of interventions to improve various indices of
      self-regulation in FASD is critical, as this may then prevent later adverse outcomes. The
      Alert Program® is an evidence-based intervention program that focuses on self-regulation. It
      is a widely-used program that demonstrated some efficacy in children with FASD with
      improvements on parental reports of EF, behavioural and emotional regulation, and tests of
      social cognition, inhibitory control and emotional problem-solving. The investigators
      anticipate that this intervention, which has not been studied in adolescents with FASD, will
      lead to improvements across a range of self-regulatory functions including cognitive,
      behavioral, and physiological indicators.

      Method:

      Participants. FASD Group: Recruitment and data collection in Alberta will occur in Dr.
      Rasmussen's and Pei's research lab at the Glenrose Rehabilitation Hospital (GRH) and with Dr.
      Oberlander in the Child and Family Research Institute at the University of British Columbia
      (under a separate University of British Columbia ethics application). The GRH facility
      consists of testing rooms, offices, and workstations. Participants who have participated in
      previous research studies by Drs. Pei and Rasmussen will be informed about the study by a
      research assistant and will be provided an information letter. Parents will then have the
      opportunity to discuss the study further and set up an appointment with the research
      assistant or they may contact the lab at a later time should they choose to participate.
      Eligible participants not currently involve in the investigators' studies will receive an
      information letter from the FASD Clinic at the GRH describing the study to all eligible
      participants (in the mail or when they are seen by the clinic), who will be blinded from
      researchers. Interested caregivers will then contact the researchers if they want to
      participate, and the project coordinator will book testing sessions. For all cognitive
      assessments, a trained Research Assistant will administer assessment measures with
      participants while the caregiver completes questionnaires and rating scales. For those
      interested participants who have recently been involved in another study, cognitive test
      results will be shared between studies to minimize the baseline testing time for the
      participants, and reduce practice effects as some measures cannot be re-administered within a
      short time frame. Caregivers will also complete a 45-minute training module and worksheet
      (~15 minutes) at baseline testing. This training module will provide an overview of the
      program as well as discuss the five categories (mouth, move, touch, look and listen) that
      will form the base of the intervention strategies for their teen. An RA trained in the
      intervention who has access to Occupational Therapy consult will be conducting the
      interventions.

      Procedure:

      Study Design: All participants with FASD will be tested on the assessment battery at Baseline
      (Time 0) which will provide important information on the profile of self-regulation
      impairments in FASD, as well as baseline data against which efficacy of the intervention can
      be evaluated. The FASD group will then be divided into the targeted intervention group (Group
      A) and a waitlist control group (Group B) and both groups will be tested on the battery of
      tests after the intervention. The waitlist group will be tested once more after a waiting
      period, but before they receive the intervention. This mixed design allows the investigators
      to control for change due to development, practice effects, regression to the mean, and
      familiarity with the procedures. Rolling recruitment is required so that interventions are
      not all running at the same time, ensuring sufficient staff and resources to administer the
      interventions. The investigators feel it is important to provide the intervention to all
      participants using a waitlist design in a timely manner for ethical and clinical reasons.

      The Alert Program® will be administered individually to participants by a trained RA or
      occupational therapist (e.g. post-doctoral fellow or a graduate student in Psychology or
      Occupational Therapy) in the investigators' lab space. A different RA will conduct all post
      intervention testing. Baseline testing will be conducted by the interventionist RA in order
      to establish a rapport and gain clinical knowledge to plan and individualize sessions to meet
      participants needs. The intervention is based on a teen adaptation of the Alert Program
      developed by Therapy Works Inc modified by the research team to meet the needs of adolescents
      with FASD. The intervention will consist of 12 one hour sessions that take place over the
      course of 9-15 weeks. Over the course of the 12 sessions the participants will work on moving
      through 3 stages (stage 1 - identifying engine speeds, stage 2- learning strategies to change
      engine levels, stage 3 - regulating engine speeds).

      Measures: The investigators will be using a number of different measures for pre and post
      analysis of behavioural, cognitive, and physiological changes. The behavioural measures are:
      background questionnaire, Behavioural Rating Inventory of Executive Function (BRIEF)- 2,
      Monetary Choice Questionnaire, Dot-Probe Test of Attention Bias to Threat, Adolescent
      Self-Regulatory Inventory (ASRI), Adaptive Behaviour Rating System (ABAS)-2, Child Behavior
      Checklist (CBCL) (youth self-report, caregiver report), and The Stressful Urban Life Events
      Scale. The cognitive measures are: Wide Range Intelligence Test (WRIT), Delis-Kaplan
      Executive Function System (D-KEFS), Iowa Gambling Test (IGT), Whack-A-Mole Test, and the Rey
      Complex Figure Test. The physiological measures include both salivary cortisol and fingernail
      cortisol samples, and the Pediatric Sleep Questionnaire (PSQ).
    

Intervention name(s): Self-Regulation Intervention adapted from the Alert Program ®
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment