Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurod… (NCT00164346) | Clinical Trial Compass
CompletedPhase 1/2
Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurodevelopmental Disorder (ARND)
United States100 participantsStarted 2002-01
Plain-language summary
Children will receive comprehensive evaluations through the Children's Research Triangle (CRT) clinical program. The assessment for the child will be in accordance with the protocol developed by Astley and Clarren as performed by one of the clinic pediatricians and final diagnosis will be according to Institute of Medicine (IOM) criteria. Children will be randomized into either a Treatment or Control group. The Treatment group will receive (in addition to standard referrals) neurocognitive habilitation and psychotherapy services as well as parent psychoeducation. The Control group will be referred for intervention through existing community and school-based agencies.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged 6 to 12 years
* Children in the care of Illinois foster care
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on 'foster care placement stability' as its main outcome — can you help me understand what that tells us about whether the neurocognitive habilitation program actually improved my child's thinking or behavior skills, or does it mainly show whether kids stayed in their placements?
2Since this was a Phase 1/Phase 2 trial that's now completed, what do we know so far about the safety and effectiveness of this kind of neurocognitive habilitation for children with FAS or ARND, and has it moved forward into larger studies?
3My child has been diagnosed with FAS or ARND — are there published results from this trial that my care team could review to see if this type of intervention might be relevant to our situation?
4How does neurocognitive habilitation compare to the standard supports or therapies already available for children with FAS or ARND, and would it make more sense to start with those before considering approaches tested in early-phase research like this?
5This trial was specifically designed around children in foster care — if my child is in a different living situation, does that affect whether findings from this study would even apply to them?'
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.