Menu
Recruiting NCT05686473

Psychoeducation of Parents to Children With FASD

No phase Interventional Fetal Alcohol Spectrum Disorders Behavior Problem Adaptive Behavior Learning Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Program of psychoeducation of parents and professionals.
Who it may be relevant to
Registry conditions: Fetal Alcohol Spectrum Disorders, Behavior Problem, Adaptive Behavior, Learning Disorders. Basic parameters: 2 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of a Treatment Program Based on Psychoeducation of Parents of Children and Adolescents With Fetal Alcohol Spectrum Disorder (FASD)

Overview

By longitudinal, prospective research in children and adolescents with Fetal Alcohol Spectrum Disorders (FASD) and their parents to explore the beneficial effects of participating in a standardized intervention program in order to treat and reduce the consequences of early brain damage. By using elements from international programs based on psychoeducation and parent training, the investigators aim to help parents to better understand and respond to the neurodevelopmental disabilities of their children, and thereby improving behavioral problems and self-regulation deficits.

Detailed description

The main aim of this research project is to evaluate the effects of a standardized intervention program for parents and professionals working with children and adolescents with FASD. Focus will be on care-persons' knowledge and skills and psychoeducation with regard to improved handling of behavioral problems and deficits in self-regulation due to FASD.

To achieve this aim objectives will be:

* to collect and analyse data on family empowerment, parenting skills and stress before and after participation in the intervention program. * to collect and analyse data on the child's behavior and deficits in self-regulation before and after participation in the intervention program. * to collect and analyse data on professionals' knowledge of FASD before and after participation in the intervention program.

The current study hypothesizes that caregivers who understand and view their children's behavior from a neurodevelopmental perspective are more likely to feel competence, use antecedent strategies, and thereby reduce child problem behavior and improve functional outcome (Fig. 2). The investigators hypothesize that participation in this program will improve parental empowerment and child self-regulation and behavior compared with baseline assessments.

Interventions

  • Behavioral Program of psychoeducation of parents and professionals
    The program consists of a standardized manual-based treatment package as an easily accessible treatment tool for use by professionals in the specialist health services, who have treatment responsibilities for children diagnosed with FASD in Norway. The intervention program will last for about 2 months and includes eight sessions, including six digitally based, interactive psychoeducational sessions. Topics will be: 1. General information about FASD 2. Intervention strategies in kindergartens/

Primary outcome measures

  • The Children's Global Assessment Scale (CGAS) [Time frame: up to 10 months]
  • The Family Empowerment Scale (FES) [Time frame: up to 10 months]
Secondary outcome measures (4)
  • The Eyberg Child Behavior Inventory (ECBI) [Time frame: up to 10 months]
  • The Social Responsiveness Scale, Second Edition (SRS-2) [Time frame: up to 10 months]
  • The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) [Time frame: up to 10 months]
  • The Parenting Stress Index (PSI) [Time frame: up to 10 months]

Eligibility criteria

All children and adolescents (age 2,5-18 years) referred to the Regional Competence Centre for children with prenatal alcohol exposure in Arendal, Norway will be invited to participate in the current research project.

Inclusion criteria

  • Valid information about alcohol exposure in fetal life. Exceptions to this inclusion criterion are children who have been adopted and with dysmorphic features that are consistent with full Fetal Alcohol Syndrome.

Exclusion criteria

  • Children with known genetic syndromes, progressive brain and neuromuscular diseases or major sensory defects (blindness or deafness).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

Norway · 1 center
  • Sørlandet Hospital — Arendal

Identifiers

NCT: NCT05686473 · NorFASDstudy1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗