Fetal Alcohol Spectrum DisordersNCT02457676
Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
A study testing Alert Program for Self-Regulation in people with Fetal Alcohol Spectrum Disorders, run by The Hospital for Sick Children.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Alert Program for Self-Regulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- FASD: diagnosis of FAS/pFAS or ARND OR
- healthy child
Who cannot join
- 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)
About this study
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.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Alert Program for Self-Regulation
- Keywords
- Self-Regulation Training, Neuroimaging, Response Inhibition, Behavioral Regulation, Emotional Regulation
- Medical subject headings
- Fetal Alcohol Spectrum Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alert Program for Self-RegulationBehavioural
Children attend 12 1.5 hour weekly sessions. Alert uses the analogy of a car engine to help children identify their own self-regulatory behavior. Children learn strategies to regulate their own "engine speed" in different situations.
| Study group | Role | What they receive |
|---|---|---|
| Alert Program for Self-Regulation | Experimental | Participants with FASD who received the Alert Program for Self-Regulation therapy between the two testing periods. Receives: Behavioral: Alert Program for Self-Regulation |
| FASD Alert Waitlist | No intervention | 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 | Normally developing controls not exposed to alcohol in utero who were not treated between the two testing periods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion regulation
Evaluated by parent questionnaires
Measured: 14 weeks after initial testing
Secondary outcomes (6)
Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF
Evaluated by neuropsychological tests
Measured: 14 weeks after initial testing
Social cognition: Saltzman's Social Cognitive Task; NEPSY
Evaluated by neuropsychological tests
Measured: 14 weeks after initial testing
Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist
Evaluated by parent questionnaires
Measured: 14 weeks after initial testing
Brain structure: Voxel-based morphometry
Voxel-based morphometry analyses
Measured: 14 weeks after initial testing
Brain structure: Cortical thickness
Civet pipeline
Measured: 14 weeks after initial testing
Brain function: Functional MRI
Response inhibition paradigm
Measured: 14 weeks after initial testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startOct 2009
- Primary completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Joanne Rovet, The Hospital for Sick Children
- Investigators
- Joanne Rovet, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457676
- Sponsor's protocol ID
- 1000014076
- Status last verified
- May 2015
- First submitted
- 19 Nov 2014
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Soh DW, Skocic J, Nash K, Stevens S, Turner GR, Rovet J. Self-regulation therapy increases frontal gray matter in children with fetal alcohol spectrum disorder: evaluation by voxel-based morphometry. Front Hum Neurosci. 2015 Mar 4;9:108. doi: 10.3389/fnhum.2015.00108. eCollection 2015.
PubMed 25788884Nash K, Stevens S, Greenbaum R, Weiner J, Koren G, Rovet J. Improving executive functioning in children with fetal alcohol spectrum disorders. Child Neuropsychol. 2015;21(2):191-209. doi: 10.1080/09297049.2014.889110. Epub 2014 Jul 10.
PubMed 25010354
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
- ClinicalTrials.gov ID
- NCT02457676
- Acronym / sponsor ID
- 1000014076
- Conditions
- Fetal Alcohol Spectrum Disorders
- Keywords
- Self-Regulation Training, Neuroimaging, Response Inhibition, Behavioral Regulation, Emotional Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2009
- Primary completion
- Jun 2012 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alert Program for Self-Regulation | Experimental | Behavioral: Alert Program for Self-RegulationParticipants with FASD who received the Alert Program for Self-Regulation therapy between the two testing periods. |
| FASD Alert Waitlist | No intervention | –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 | –Normally developing controls not exposed to alcohol in utero who were not treated between the two testing periods. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- FASD: diagnosis of FAS/pFAS or ARND OR
- healthy child
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alert Program for Self-RegulationChildren attend 12 1.5 hour weekly sessions. Alert uses the analogy of a car engine to help children identify their own self-regulatory behavior. Children learn strategies to regulate their own "engine speed" in different situations. | Behavioural | Alert Program for Self-Regulation |
Primary outcome
Emotion regulation
Time frame: 14 weeks after initial testing
Evaluated by parent questionnaires
6 secondary outcomes
Inhibitory control: Test of Everyday Attention for Children; NEPSY, BRIEF
Time frame: 14 weeks after initial testing
Social cognition: Saltzman's Social Cognitive Task; NEPSY
Time frame: 14 weeks after initial testing
Behavior: Behavior Rating Inventory of Executive Function; Child Behavior Checklist
Time frame: 14 weeks after initial testing
Brain structure: Voxel-based morphometry
Time frame: 14 weeks after initial testing
Brain structure: Cortical thickness
Time frame: 14 weeks after initial testing
Brain function: Functional MRI
Time frame: 14 weeks after initial testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Results publication: PubMed 25788884Soh DW, Skocic J, Nash K, Stevens S, Turner GR, Rovet J. Self-regulation therapy increases frontal gray matter in children with fetal alcohol spectrum disorder: evaluation by voxel-based morphometry. Front Hum Neurosci. 2015 Mar 4;9:108. doi: 10.3389/fnhum.2015.00108. eCollection 2015.
- Results publication: PubMed 25010354Nash K, Stevens S, Greenbaum R, Weiner J, Koren G, Rovet J. Improving executive functioning in children with fetal alcohol spectrum disorders. Child Neuropsychol. 2015;21(2):191-209. doi: 10.1080/09297049.2014.889110. Epub 2014 Jul 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Rovet, PhD principal investigator
The Hospital for Sick Children
Questions about this trial
What is this clinical trial studying?
A study testing Alert Program for Self-Regulation in people with Fetal Alcohol Spectrum Disorders, run by The Hospital for Sick Children.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion regulation (time frame: 14 weeks after initial testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02457676, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.