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CompletedNCT00164528Updated Sep 14, 2005

Intervening With Children/Adolescents With FAS/ARND

A Phase 1/2 interventional study of Positive Behavior Support in Treatment and Control, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in United States. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-09-14.

Sponsored by Centers for Disease Control and Prevention · Phase 1/2, Interventional, and Educational/counseling/training

Phase
Phase 1/2
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study summary

Children diagnosed through the FAS DPN clinic (who receive non-study services through the clinic/referrals) will receive baseline assessment. The baseline assessment for the child will include: medical issues (including medication), intellectual assessment, academic achievement, language, social functioning, executive functioning, neurological assessment, perceived self-confidence, and behavioral observation of parent-child interactions (videotaped and coded). For caregivers, baseline assessment will include: demographics, medical histories, educational history, current services, satisfaction with services, knowledge of FAS, stress, parenting competence, and family functioning.

Read the detailed description

Functional analysis of challenging behaviors will be conducted. Intervention will be an individualized, multimodal, behavioral consultation. The consultation will include: FAS education, emotional/practical support, and teaching child management strategies specific to children with FAS/ARND, advocacy assistance, and school consultation. Specific procedure will be based on previous findings and experience. In particular, specialized "Behavior Support Plans" will be developed for each child with input from parents, teachers, and clinicians.

Team consultations at the child's home during weekly visits. Instruction will include information on FAS, behavioral strategies, and information for advocating with service systems.

Evaluation Plan: Both interventions: Treatment and control groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 9-month follow-up (end of school year).

02

Conditions studied

  • Treatment
  • Control
03

In context

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • children 5 to 12 years of age

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Educational/counseling/training
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
52 participants

Interventions

  • BehavioralPositive Behavior Support
06

What researchers measure

Primary outcomes

  1. behavior

07

Study locations

1 site
  • University of Washington
    Seattle, Washington 98195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00164528
Lead sponsor
Centers for Disease Control and Prevention
Collaborators
University of Washington
First posted
Sep 14, 2005
Start date
Oct 2001
Completion
Jun 2005
Last update
Sep 14, 2005

Study contacts

Susan Astley, PhD
principal investigator · University of Washington
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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