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

NCT02912962 | Completed

• 1 other identifier: 00064830
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (14)

• Delis-Kaplan Executive Function System (D-KEFS)

  a widely-used, normed measure of EF. Participants will complete the 2 subtests: trail making (cognitive flexibility and switching) and color-word interference (inhibition and switching).

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Iowa Gambling Test (IGT)

  a computerized measure of decision making which involves behavioral and emotional regulation. Participants start with $2000 of theoretical money and have to choose cards one at a time from four decks (A, B, C, and D) to earn as much money as they can. There are two disadvantageous decks (large initial rewards and large losses) and two advantageous decks (small immediate rewards and smaller losses).

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Whack-A-Mole Test

  A computerized Go/NoGo paradigm will be used to measure inhibitory control, modeled after the "whack-a-mole" arcade game. Participants press a button every time a mole appears in monitored 'garden hole', but withhold responding when a garden vegetable appears. This task has been sensitive to interventions in previous studies of children with FASD.

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Monetary Choice Questionnaire

  Is a measure of affective decision making in children and a measure of hot EF. In this task participants will be asked to choose if they would rather a smaller amount of money now, or a larger amount later. Participants will be informed to answer as if they are actually receiving the money, but will be informed that the test is hypothetical, and they will not actually be receiving money on this task. This task is a form of measuring delay of gratification, where participants have to choose between a smaller award given immediately, or waiting and receiving a larger award. Performance on Delay of Gratification tests in early childhood is associated with academic, social, and mental well-being later on in life.

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Dot Probe Task

  Dot-probe task is a spatially oriented attention task that is administered via computer. The task aims to capture attentional bias toward emotional cues, and is primarily used to investigate threat-related attentional bias. Participants are briefly shown two stimuli, one threat-related and one neutral. They are then shown a small probe in the same location as one of the stimuli. Participants are required to respond as quickly as possible to the probe. Response times are thought to indicate the distribution of the participants' attention, with faster response times to probes in the attended to location. Attentional bias towards threat is demonstrated when participants attend quicker to probes that replace threat-related stimuli.

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Rey Complex Figure Test (RCFT)

  The RCFT is a neuropsychological assessment tool that requires examinees to copy a complex geometric design with multiple embedded details, and then re-create the figure from memory. The tool places demands on many cognitive functions, including planning/organization, attention, visual-spatial perception and construction, motor ability, and memory encoding, storage, and retrieval processes. Evaluations of reliability and validity for the RCFT have proved excellent, with a median inter-rater reliability of .94. Based on the factor analyses, the RCFT appears to capture five domains of cognitive functioning: visuospatial recall memory, visuospatial recognition memory, response bias, processing speed, and visuospatial constructional ability.

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Behavioral Rating Inventory of Executive Function- 2 (BRIEF-2)

  Caregivers will complete the BRIEF-2, a widely-used normed measure of EF including inhibition, set shifting, emotional control, working memory, planning, organization, and monitoring skills.

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Adolescent Self-Regulatory Inventory (ASRI)

  The ASRI is self-report a measure of self-regulation (e.g. managing negative emotions, defer gratification) in adolescents.

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Adaptive Behavior Assessment System (ABAS-2)

  The ABAS-II provides a comprehensive, norm-referenced assessment of the adaptive behavior and skills of individuals from birth to age 89.

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Child Behavior Checklist (CBCL)

  The CBCL is a 117-item questionnaire that measures the competence and problem areas of children ages 6-18, as reported by caregivers and youth 11-18 years. The test yields scores in eight problem scales of behavioral and emotional problems labeled as: Withdrawn, Anxious/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Delinquent Behavior, and Aggressive Behavior. These scales can be summarized into three broader scales: Externalizing problems (Aggressive Behavior, Delinquent Behavior), Internalizing problems (Withdrawn, Somatic Complaints, Anxious/Depressed) and Total Problems. Scores are also given in three competence areas: social settings, activities, and school settings.

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Health Habits Questionnaire

  A 22 item self-report questionnaire focusing on the adolescent's preferences for physical activity, leisure, hobbies and interests, and sleeping habits (attached to ethics application). The information gathered from this questionnaire will be used to further individualize the intervention for the participant and will provide the interventionist with important information to assist in the improvement of self-regulation.

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Paediatric Sleep Questionnaire (PSQ)

  The PSQ is a pen-and-paper parent questionnaire designed to screen for common sleep problems in children. The questionnaire includes 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behavior, and other pediatric features.

  change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group)

• Cortisol

  Two key indicators of HPA activity will be collected as physiological measures of self-regulation - the cortisol awakening response (CAR), and overall cortisol diurnal rhythm. Both cortisol diurnal rhythm and the CAR will be sampled at home.

  Between Pre and Post intervention (12 weeks) 1) immediately upon awakening (AM sample); 2) within 30-minutes of bedtime (PM sample). Both salivary samples will be taken on two different days within a five-day period

• Fingernail Cortisol

  The human stress response is regulated in part by the hypothalamic-pituitary-adrenal (HPA) axis. Activation of the HPA axis results in the release of cortisol and related steroids from the adrenal cortex. There are well-established techniques for measuring levels of cortisol using saliva, urine and blood. However, nail clipping is more acceptable under most circumstances, and nails are known for their resistance to decomposition and disintegration. A recent pilot study (Warnock et al., 2010) indicates that fingernail analysis allows one to assess accumulated hormone levels over a period of approximately 2-3 months, and thus analysis of fingernail cortisol could provide a novel measure of long-term HPA regulation/dysregulation in subjects in our proposed study.

  approximately 2-3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Cognitive testing 1, 12 intervention sessions, Cognitive testing 2, Approximately a 12 week wait (no intervention), Cognitive testing 3. The intervention is a 12 week, individualized, one-on-one self-regulation intervention where adolescents will learn to attain, change, or maintain an appropriate level of alertness .

Behavioral: Self-Regulation Intervention adapted from the Alert Program ®

Waitlist

EXPERIMENTAL

Cognitive testing 1, Approximately a 12 week wait (no intervention), Cognitive testing 2, 12 intervention sessions, Cognitive testing 3

Behavioral: Self-Regulation Intervention adapted from the Alert Program ®

Interventions

Self-Regulation Intervention adapted from the Alert Program ® BEHAVIORAL

Intervention Group; Waitlist

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The study includes participants with an Intelligence Quotient \< 70 to allow for a range of cognitive abilities.

Sponsors & Collaborators

• University of Alberta: lead
• Glenrose Foundation: collaborator
• Woman and Children's Health Research Institute: collaborator
• NeuroDevNet: collaborator
• Provincial Health Services Authority British Columbia: collaborator
• University of British Columbia: collaborator

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Self-Control; Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 17, 2018

Record last verified: 2017-10

Locations

CA (2)