Dialogical Family Guidance for Neurodevelopmental Disorders

Family Dynamics Clinical Trial

— DFG  

Official title:

Dialogical Family Guidance in Families With a Child With Neurodevelopmental Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892992
• Other study ID #: 106/13/03/03/2012
• Status: Completed
• Phase: N/A
• Start date: January 6, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2021
• Source: Tampere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous studies have highlighted the need to offer targeted effective interventions to strengthen the wellbeing of all family members in families with children with neurodevelopmental disorders (NDD). Interventions for this target group requires development and research. A new family intervention, Dialogical Family Guidance (DFG) was tested in this study. All families received DFG intervention ( 6 meetings ).

Description:

Previous studies have highlighted the need to offer targeted effective interventions to strengthen the wellbeing of all family members in families with children with neurodevelopmental disorders (NDD). Interventions for this target group requires development and research. A new family intervention, Dialogical Family Guidance (DFG) was tested in this study.

Fifty families of children with NDD were randomized into two intervention groups. Intervention group I were delivered DFG immediately, and Intervention group II were delivered DFG after three months. Family functionality, health and support (FAFHES), SDQ and the 5-15-questionnaire and DFG parent questionnaires were used to collect data at baseline, after three and six months. Fifty families were invited to the study. Thirty-four families completed the study. A comparison were made between Intervention group I and II.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

• clinical neurodevelopmental disorder diagnosis (eg ADHD, ASD, tics, language disorders)

• the child is aged between 4-16 years

• parent have adequate Finnish language skills

• parents are biological parents or step-parents of the child

Exclusion Criteria:

• the child is under 4 or over 16 years old

• parents do not have adequate Finnish language skills

Related Conditions & MeSH terms

• Family Dynamics
• Neurodevelopmental Disorders

Intervention

Behavioral:
• DFG

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diana Cavonius-Rintahaka

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Family Function, Health and Social Support - scale (FAFHES)	The FAFHES questionnaire contains three sections; family functionality (19 items), family health (23 items), and family support provided by professionals (21 items). All the items are measured on a Likert scale ranging from 1-6 (I disagree totally, I disagree, I disagree somewhat, I agree somewhat, I agree, I agree totally). Family functionality, family health and family support were seen as poor if the median was 1.00-2.7, moderate if it was 2.8-4.5, and good if it was 4.6-6.0.45. Parent questionnaire. 1=I totally disagree.....6=I absolutely agree. Higher scores mean worse outcome.	Baseline measure before DFG family intervention starts
Primary	The Family Function, Health and Social Support Scale (FAFHES)	The FAFHES questionnaire contains three sections; family functionality (19 items), family health (23 items), and family support provided by professionals (21 items). All the items are measured on a Likert scale ranging from 1-6 (I disagree totally, I disagree, I disagree somewhat, I agree somewhat, I agree, I agree totally). Family functionality, family health and family support were seen as poor if the median was 1.00-2.7, moderate if it was 2.8-4.5, and good if it was 4.6-6.0.45. Parent questionnaire. 1=I totally disagree.....6=I absolutely agree. Higher scores mean worse outcome.	3 months after baseline measure, when intervention is finished. Change is being assessed.
Primary	The Family Function, Health and Social Support Scale (FAFHES)	The FAFHES questionnaire contains three sections; family functionality (19 items), family health (23 items), and family support provided by professionals (21 items). All the items are measured on a Likert scale ranging from 1-6 (I disagree totally, I disagree, I disagree somewhat, I agree somewhat, I agree, I agree totally). Family functionality, family health and family support were seen as poor if the median was 1.00-2.7, moderate if it was 2.8-4.5, and good if it was 4.6-6.0.45. Parent questionnaire. 1=I totally disagree.....6=I absolutely agree. Higher scores mean worse outcome.	6 months after baseline follow up. Change is being assessed.
Secondary	The Dialogical Family Guidance (DFG) - questionnaire	The DFG-questionnaire was developed for this study to obtain information and parents' experiences about the DFG family intervention. The questionnaire include 14 items. Questions about the content and recommendation of DFG sessions were for example: "Did you get practical tips for daily life?" (1= yes absolutely….5=not at all) and "Would you recommend DFG to other parents?" (1=yes absolutely….4=no). The following semi-structured open-ended question was included in the DFG-questionnaire: Could you describe your experiences, comments or/and ideas about how to improve DFG? Parents filled the questionnaire after completing the DFG process (six meetings). Most questions were opinions about DFG, but when questions about "Did you get help from DFG?" 1=very much.... 5=not at all	3 months after baseline measure, when intervention is finished.
Secondary	The Strengths and Difficulties Questionnaire (SDQ)	SDQ measures the changes in child's behavior. 25 items with 3-point likert scale; Not true (0)- Somewhat true (1) - Certainly true (2). Parent questionnaire. Higher scores mean worse outcome considering the child with neurodevelopmental disorder.Highest scores 50 - lowest 0. Total score16-40 = high risk for abnormalities.	Baseline measure before DFG family intervention starts
Secondary	The Strengths and Difficulties Questionnaire (SDQ)	SDQ measures the changes in child's behavior. 25 items with 3-point likert scale; Not true (0)- Somewhat true (1) - Certainly true (2). Parent questionnaire. Higher scores mean worse outcome considering the child with neurodevelopmental disorder.Highest scores 50 - lowest 0. Total score16-40 = high risk for abnormalities.	3 months after baseline measure, when intervention is finished. Change is being assessed.
Secondary	The Strengths and Difficulties Questionnaire (SDQ)	SDQ measures the changes in child's behavior. 25 items with 3-point likert scale; Not true (0)- Somewhat true (1) - Certainly true (2). Parent questionnaire. Higher scores mean worse outcome considering the child with neurodevelopmental disorder.Highest scores 50 - lowest 0. Total score16-40 = high risk for abnormalities.	6 months after baseline follow up. Change is being assessed.
Secondary	Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)	Parent Questionnaire for evaluation of development and behaviour in 5-15-year old children. 181 items. Three point likert scale; Not true (0) - Somewhat true (1)- Certainly true (2). Higher scores mean worse outcome considering the child. 0-13 scores normal and 17-40 scores mean abnormal result/abnormal	Baseline measure before DFG family intervention starts
Secondary	Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)	Parent Questionnaire for evaluation of development and behaviour in 5-15-year old children. 181 items. Three point likert scale; Not true (0) - Somewhat true (1)- Certainly true (2). Higher scores mean worse outcome considering the child. 0-13 scores normal and 17-40 scores mean abnormal result/abnormal	3 months after baseline measure, when intervention is finished. Change is being assessed.
Secondary	Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)	Parent Questionnaire for evaluation of development and behaviour in 5-15-year old children. 181 items. Three point likert scale; Not true (0) - Somewhat true (1)- Certainly true (2). Higher scores mean worse outcome considering the child. 0-13 scores normal and 17-40 scores mean abnormal result/abnormal	6 months after baseline follow up. Change is being assessed.