Clinical trial NCT05686473: Psychoeducation of Parents to Children With FASD
Official title: Evaluation of a Treatment Program Based on Psychoeducation of Parents of Children and Adolescents With Fetal Alcohol Spectrum Disorder (FASD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Behavior Problem
Adaptive Behavior
Learning Disorders
Keywords: FASD
Psychoeducation
Parenting
Information program
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2023-01-17
Enrollment: 75
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Assessments with the evaluation measures will be performed at referral to Regional competence centre/inclusion to study (baseline), at admission to the centre 4-5 months later (pre-intervention), and 4-5 months after finishing program (post-intervention). The period between baseline and pre-intervention will be regarded as a control period, in contrast to the intervention period.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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).

Primary outcomes:
measure: The Children's Global Assessment Scale (CGAS)
timeFrame: up to 10 months
measure: The Family Empowerment Scale (FES)
timeFrame: up to 10 months
Secondary outcomes:
measure: The Eyberg Child Behavior Inventory (ECBI)
timeFrame: up to 10 months
measure: The Social Responsiveness Scale, Second Edition (SRS-2)
timeFrame: up to 10 months
measure: The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
timeFrame: up to 10 months
measure: The Parenting Stress Index (PSI)
timeFrame: up to 10 months
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sørlandet Hospital
Study officials:
affiliation: Sørlandet Hospital HF
name: Jon S Skranes, Dr Med
role: PRINCIPAL_INVESTIGATOR
References: