Fetal Alcohol Spectrum DisordersNorFASDPEduNCT05686473
Psychoeducation of Parents to Children With FASD
A study testing Program of psychoeducation of parents and professionals in people with Fetal Alcohol Spectrum Disorders and Behavior Problem, run by Sorlandet Hospital HF at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders, Behavior Problem, Adaptive Behavior
- What is being tested?
- Program of psychoeducation of parents and professionals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Children with known genetic syndromes, progressive brain and neuromuscular diseases or major sensory defects (blindness or deafness).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Sørlandet Hospital
Arendal, 4809
Jon S Skranes, Dr med, 99390285, jon.skranes@sshf.no
About this study
Official title: Evaluation of a Treatment Program Based on Psychoeducation of Parents of Children and Adolescents With Fetal Alcohol Spectrum Disorder (FASD)
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.
Read the 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.
- Being tested
- Program of psychoeducation of parents and professionals
- Keywords
- FASD, Psychoeducation, Parenting, Information program
- Medical subject headings
- Fetal Alcohol Spectrum Disorders, Mental Disorders, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program of psychoeducation of parents and professionalsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | Single arm study. The family with child with FASD will act as its own control in the period before intervention starts. Receives: Behavioral: Program of psychoeducation of parents and professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 10 months
Secondary outcomes (4)
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.
Measured: up to 10 months
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.
Measured: up to 10 months
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.
Measured: up to 10 months
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.
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jon S Skranes, Dr Med, Principal investigator, Sørlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686473
- Sponsor's protocol ID
- NorFASDstudy1
- Acronym
- NorFASDPEdu
- Status last verified
- May 2025
- First submitted
- 2 Jan 2023
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Treatment Program Based on Psychoeducation of Parents of Children and Adolescents With Fetal Alcohol Spectrum Disorder (FASD)
- ClinicalTrials.gov ID
- NCT05686473
- Acronym / sponsor ID
- NorFASDPEdu / NorFASDstudy1
- Keywords
- FASD, Psychoeducation, Parenting, Information program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Behavioral: Program of psychoeducation of parents and professionalsSingle arm study. The family with child with FASD will act as its own control in the period before intervention starts. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Children with known genetic syndromes, progressive brain and neuromuscular diseases or major sensory defects (blindness or deafness).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program of psychoeducation of parents and professionalsThe 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 | Behavioural | Patient group |
Primary outcome
The Children's Global Assessment Scale (CGAS)
Time frame: up to 10 months
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.
The Family Empowerment Scale (FES)
Time frame: up to 10 months
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Homepage for Regional competence center for children with prenatal alcohol/drug exposureLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Fetal Alcohol Spectrum Disorders
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FASD Prevention R33
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Families Moving Forward (FMF) Connect Pro for Mental Health Providers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jon S Skranes, Dr Med principal investigator
Sørlandet Hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program of psychoeducation of parents and professionals in people with Fetal Alcohol Spectrum Disorders and Behavior Problem, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Cecilie Tveiten, PhD student (+47-370-75750, Anne.Cecilie.Tveiten@sshf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Children's Global Assessment Scale (CGAS) (time frame: up to 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.