Intervening With Children/Adolescents With FAS/ARND

• Sponsor: Centers for Disease Control and Prevention (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00164528
• Collaborator: University of Washington (Other)
• Enrollment: 52
• Location: 1
• Duration (Months): 44
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Treatment; Control	Behavioral: Positive Behavior Support	Phase 1/Phase 2

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).

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Educational/Counseling/Training
• Official Title: Intervening With Children/Adolescents With FAS/ARND
• Study Start Date: Oct 1, 2001
• Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

1. behavior []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• children 5 to 12 years of age

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98195

Sponsors and Collaborators

• Centers for Disease Control and Prevention
• University of Washington

Investigators

• Principal Investigator: Susan Astley, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00164528
• Other Study ID Numbers: CDC-NCBDDD-3752; U84/CCU020163-02
• First Posted: Sep 14, 2005
• Last Update Posted: Sep 14, 2005
• Last Verified: Sep 1, 2005

Study Results

No Results Posted as of Sep 14, 2005