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Psychoeducation of Parents to Children With FASD (ParentEdFASD)

Primary Purpose

Fetal Alcohol Spectrum Disorders, Behavior Problem, Adaptive Behavior

Status
Not yet recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Program of psychoeducation of parents and professionals
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fetal Alcohol Spectrum Disorders focused on measuring FASD, Psychoeducation, Parenting, Information program

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Sørlandet Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient group

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 2, 2023
Last Updated
January 5, 2023
Sponsor
Sorlandet Hospital HF
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1. Study Identification

Unique Protocol Identification Number
NCT05686473
Brief Title
Psychoeducation of Parents to Children With FASD
Acronym
ParentEdFASD
Official Title
Evaluation of a Treatment Program Based on Psychoeducation of Parents of Children and Adolescents With Fetal Alcohol Spectrum Disorder (FASD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders, Behavior Problem, Adaptive Behavior, Learning Disorders
Keywords
FASD, Psychoeducation, Parenting, Information program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient group
Arm Type
Experimental
Arm Description
Single arm study. The family with child with FASD will act as its own control in the period before intervention starts.
Intervention Type
Behavioral
Intervention Name(s)
Program of psychoeducation of parents and professionals
Intervention Description
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
Primary Outcome Measure Information:
Title
The Children's Global Assessment Scale (CGAS)
Description
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 months
Title
The Family Empowerment Scale (FES)
Description
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 months
Secondary Outcome Measure Information:
Title
The Eyberg Child Behavior Inventory (ECBI)
Description
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 months
Title
The Social Responsiveness Scale, Second Edition (SRS-2)
Description
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 months
Title
The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Description
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 months
Title
The Parenting Stress Index (PSI)
Description
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 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Cecilie Tveiten, PhD student
Email
Anne.Cecilie.Tveiten@sshf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Gro CC Løhaugen, PhD
Phone
+47-370-75750
Email
Gro.lohaugen@sshf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon S Skranes, Dr Med
Organizational Affiliation
Sørlandet Hospital HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sørlandet Hospital
City
Arendal
ZIP/Postal Code
4809
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon S Skranes, Dr med
Phone
99390285
Email
jon.skranes@sshf.no

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://sshf.no/avdelinger/somatikk-arendal/barne-og-ungdomsavdelingen/rkmr
Description
Homepage for Regional competence center for children with prenatal alcohol/drug exposure

Learn more about this trial

Psychoeducation of Parents to Children With FASD

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