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Psychoeducation of Parents to Children With FASD (NorFASDPEdu)

S

Sorlandet Hospital HF

Status

Enrolling

Conditions

Behavior Problem
Adaptive Behavior
Fetal Alcohol Spectrum Disorders
Learning Disorders

Treatments

Behavioral: Program of psychoeducation of parents and professionals

Study type

Interventional

Funder types

Other

Identifiers

NCT05686473
NorFASDstudy1

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 estimated patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

75 participants in 1 patient group

Patient group
Experimental group
Description:
Single arm study. The family with child with FASD will act as its own control in the period before intervention starts.
Treatment:
Behavioral: Program of psychoeducation of parents and professionals

Trial contacts and locations

1

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Central trial contact

Anne Cecilie Tveiten, PhD student; Gro CC Løhaugen, PhD

Data sourced from clinicaltrials.gov

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