Clinical trial NCT00164307: Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships
Official title: Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Treatment
Control
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of California, Los Angeles
First posted: 2005-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: Children will be randomly assigned to a Parent-assisted social skills training or Wait list. Baseline and post intervention rating will be obtained from teachers.

Detailed description: Targeted Area of Intervention: Social skills and development of best friend relationships. The specific intervention will be twelve small group sessions (90 minutes each) over a 6-week period. Child sessions consist of 4 components: 1) children report on homework assignments; 2) didactic presentation, behavioral rehearsal, and coaching, 3) coached play, and 4) new homework activities assigned with parent. Topics to be addressed across sessions include: reduction of maladaptive behaviors, information exchange techniques, places and times to make friends, group acceptance, praising other children, negotiation, play dates, dealing with teasing, and winner/loser skills. At the start of the intervention, parent and children will work with staff to develop a list of social skills, behaviors, and goals that they would like targeted for each child.

Parent component: Kathleen Mitchell (NOFAS) is an investigator to provide parent input to the study. Parent-only sessions will instruct them on key features being taught to their child. Concurrent parent sessions will include: 1) education on FAS/ARND, 2) parents present specific issues with their child, 3) review of current child session objectives and techniques, 4) new homework activities developed, 5) parent and child together review homework.

Evaluation Plan: Treatment and control (WL) groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 4-month follow-up. Baseline parent measures include Social Skills Rating Scale, FAS Behavior Scale, and Test of Advocacy Knowledge. Baseline child measures include knowledge of social skills. Process (e.g., homework completion, attendance, etc) and outcome (e.g., social skills ratings, progress towards individual goals) measures will be evaluated.

Eligibility criteria: Inclusion Criteria:

* children ages 6 to 8 years
* history of prenatal alcohol exposure

Exclusion Criteria:

* non english speaking

Primary outcomes:
measure: social skills
measure: peer relationships/friendships
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of Califorrnia at Los Angeles
name: Mary O'Connor, PhD
role: PRINCIPAL_INVESTIGATOR
References: