Intervening With Children/Adolescents With FAS/ARND

This study has been completed.
Sponsor:
Collaborator:
University of Washington
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164528
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 12, 2005
September 12, 2005
October 2001
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behavior
Same as current
No Changes Posted
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Not Provided
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Intervening With Children/Adolescents With FAS/ARND
Intervening With Children/Adolescents With FAS/ARND

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.

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).

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
  • Treatment
  • Control
Behavioral: Positive Behavior Support
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
June 2005
Not Provided

Inclusion Criteria:

  • children 5 to 12 years of age

Exclusion Criteria:

-

Both
5 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00164528
CDC-NCBDDD-3752, U84/CCU020163-02
Not Provided
Not Provided
Centers for Disease Control and Prevention
University of Washington
Principal Investigator: Susan Astley, PhD University of Washington
Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP