Psychoeducation of Parents to Children With FASD

Behavior Problem Clinical Trial

— NorFASDPEdu  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05686473
• Other study ID #: NorFASDstudy1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Sorlandet Hospital HF
• Contact: Anne Cecilie Tveiten, PhD student
• Phone: +47-370-75750
• Email: Anne.Cecilie.Tveiten[@]sshf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Behavior Problem
• Fetal Alcohol Spectrum Disorders
• Learning Disabilities
• Learning Disorders
• Problem Behavior

Intervention

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: General information about FASD Intervention strategies in kindergartens/schools for children with FASD Families living with FASD - activities of daily living Self-regulatory deficits - how to cope Executive functions in daily life Social development in children with FASD Guidance in social settings Challenging behavior - what can be done

Locations

Country	Name	City	State
Norway	Sørlandet Hospital	Arendal

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Children's Global Assessment Scale (CGAS)	To evaluate effects of the intervention program well-known standardized, validated measures will be used. Primary outcome measure for the child will be The Children's Global Assessment Scale, which is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. The scale targets the number of behavioral problems and the frequency of their occurrence.The child or young person is given a single score between 1 and 100. Higher score means better functioning.	up to 10 months
Primary	The Family Empowerment Scale (FES)	Primary outcome measure for parents will be The Family Empowerment Scale to evaluate the magnitude of empowerment in the parent-child system. FES is a 34-item rating scale where the participants rate each item on a 5-point Likert-type rating scale. Scores will range between 34 and 170 points. Increasing scores indicate a positive significance regarding family empowerment.	up to 10 months
Secondary	The Eyberg Child Behavior Inventory (ECBI)	In addition, several well-known secondary measures will be used to evaluate additional effects of program. The ECBI questionnaire will be used to evaluate the number of behavioral problems and the frequency of their occurrence before and after the intervention program. ECBI provides a list of 36 problem behaviors commonly reported by parents. The inventory assesses behavior on two dimensions: 1) the frequency of the behavior; 2) whether parents consider it a problem. The frequency ratings range from 1 (never) to 7 (always), and are summed up to arrive at an overall problem behavior Intensity Score, ranging from 36 to 252. Higher score means more behavioral problems.	up to 10 months
Secondary	The Social Responsiveness Scale, Second Edition (SRS-2)	The SRS-2 questionnaire will be used to evaluate the severity of social impairment and lack of flexibility in children and adolescents before and after participation in the intervention program. Each domain's T-scores are organized by gender and respondent age, with each domain having varied but similar ranges of possible scores from 32 points-114 points. All T-scores have a mean of 50 points with a standard deviation of 10 points. Higher score means more deficits in social interaction.	up to 10 months
Secondary	The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)	The BRIEF-2 will be used to evaluate any change in executive functions after participation. Norms tables give T-scores, percentiles, and 90% confidence intervals for four developmental age groups, by gender. Three broad indexes are calculated (Behavior Regulation, Emotion Regulation, and Cognitive Regulation). Higher score means worse outcome.	up to 10 months
Secondary	The Parenting Stress Index (PSI)	The PSI questionnaire will be used to evaluate parental stress and load before and after participation in the program.The PSI yields a total score, three domain scores, and 15 subscales. Higher raw scores indicate higher levels of stress.	up to 10 months

External Links

•   Homepage for Regional competence center for children with prenatal alcohol/drug exposure