Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 36 for:    fetal alcohol children

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02912962
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
Glenrose Foundation
Woman and Children's Health Research Institute
NeuroDevNet
Provincial Health Services Authority
University of British Columbia
Information provided by (Responsible Party):
University of Alberta

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.


Condition or disease Intervention/treatment Phase
Self-regulation Adolescents Fetal Alcohol Spectrum Disorder Behavioral: Self-Regulation Intervention adapted from the Alert Program ® Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Self-Regulation in Adolescents With FASD: The Efficacy of a Targeted Intervention
Study Start Date : September 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group

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 ®
Experimental: Waitlist
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 ®



Primary Outcome Measures :
  1. Delis-Kaplan Executive Function System (D-KEFS) [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    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).

  2. Iowa Gambling Test (IGT) [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    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).

  3. Whack-A-Mole Test [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    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.

  4. Monetary Choice Questionnaire [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    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.

  5. Dot Probe Task [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    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.

  6. Rey Complex Figure Test (RCFT) [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    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.

  7. Behavioral Rating Inventory of Executive Function- 2 (BRIEF-2) [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    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.

  8. Adolescent Self-Regulatory Inventory (ASRI) [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    The ASRI is self-report a measure of self-regulation (e.g. managing negative emotions, defer gratification) in adolescents.

  9. Adaptive Behavior Assessment System (ABAS-2) [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    The ABAS-II provides a comprehensive, norm-referenced assessment of the adaptive behavior and skills of individuals from birth to age 89.

  10. Child Behavior Checklist (CBCL) [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    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.

  11. Health Habits Questionnaire [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    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.

  12. Paediatric Sleep Questionnaire (PSQ) [ Time Frame: change from pre and post intervention (12 weeks), plus 3 month wait (waitlist group), and 3 month follow up (intervention group) ]
    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.

  13. Cortisol [ Time Frame: 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 ]
    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.

  14. Fingernail Cortisol [ Time Frame: approximately 2-3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria for this study are adolescents ages 11-17 with confirmed prenatal alcohol exposure and an FASD diagnosis.
  • The study includes participants with an Intelligence Quotient < 70 to allow for a range of cognitive abilities.

Exclusion Criteria:

  • Exclusion criteria will include those with known genetic disorders (e.g., Down's syndrome), other severe neurodevelopmental disorders (e.g., autism) and significant motor/sensory impairments.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912962


Locations
Layout table for location information
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of Alberta
Glenrose Foundation
Woman and Children's Health Research Institute
NeuroDevNet
Provincial Health Services Authority
University of British Columbia

Layout table for additonal information
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02912962     History of Changes
Other Study ID Numbers: 00064830
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Fetal Alcohol Spectrum Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders