Psychoeducation of Parents to Children With FASD

NCT05686473 | Recruiting

• 1 other identifier: NorFASDstudy1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Alcohol Spectrum Disorders; Behavior Problem; Adaptive Behavior; Learning Disorders

Keywords

FASD; Psychoeducation; Parenting; Information program

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• The Eyberg Child Behavior Inventory (ECBI)

  up to 10 months

• The Social Responsiveness Scale, Second Edition (SRS-2)

  up to 10 months

• The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

  up to 10 months

• The Parenting Stress Index (PSI)

  up to 10 months

Study Arms (1)

Patient group

EXPERIMENTAL

Single arm study. The family with child with FASD will act as its own control in the period before intervention starts.

Behavioral: Program of psychoeducation of parents and professionals

Interventions

Program of psychoeducation of parents and professionals BEHAVIORAL

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/schools for children with FASD 3. Families living with FASD - activities of daily living 4. Self-regulatory deficits - how to cope 5. Executive functions in daily life 6. Social development in children with FASD 7. Guidance in social settings 8. Challenging behavior - what can be done

Patient group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sørlandet Hospital

Arendal, 4809, Norway

RECRUITING

Related Links

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

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders; Mental Disorders; Learning Disabilities

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Study Officials

• Jon S Skranes, Dr Med

  Sørlandet Hospital HF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Cecilie Tveiten, PhD student

CONTACT

+47-370-75750; Anne.Cecilie.Tveiten@sshf.no

Gro CC Løhaugen, PhD

CONTACT

+47-370-75750; Gro.lohaugen@sshf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 17, 2023
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)