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Intervening With Children/Adolescents With FAS/ARND

NCT ID: NCT00164528

Last Updated: 2005-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Treatment Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

SINGLE

Interventions

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Positive Behavior Support

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* children 5 to 12 years of age

Exclusion Criteria

\-
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Principal Investigators

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Susan Astley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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U84/CCU020163-02

Identifier Type: -

Identifier Source: secondary_id

CDC-NCBDDD-3752

Identifier Type: -

Identifier Source: org_study_id