Psychoeducation of Parents to Children With FASD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorSorlandet Hospital HF
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Children with known genetic syndromes, progressive brain and neuromuscular diseases or major sensory defects (blindness or deafness).
Trial design
Design model
Sequential
Treatments tested in this trial
Program of psychoeducation of parents and professionals
BehavioralThe 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
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Patient groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 10 months2
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.
Time frame
up to 10 monthsSecondary outcomes
1
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.
Time frame
up to 10 months2
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.
Time frame
up to 10 months3
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.
Time frame
up to 10 months4
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.
Time frame
up to 10 monthsSponsors and contacts
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Source ClinicalTrials.gov