Intervening With Children/Adolescents With FAS/ARND

Treatment Clinical Trial

Official title:

Intervening With Children/Adolescents With FAS/ARND

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164528
• Other study ID #: CDC-NCBDDD-3752
• Secondary ID: U84/CCU020163-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: October 2001
• Est. completion date: June 2005

Study information

• Verified date: September 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• children 5 to 12 years of age

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Control
• Treatment

Intervention

Behavioral:
• Positive Behavior Support

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	behavior