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Dialogical Family Guidance for Neurodevelopmental Disorders (DFG)

Primary Purpose

Family Dynamics

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DFG
Sponsored by
Diana Cavonius-Rintahaka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Family Dynamics focused on measuring Dialogical family guidance, family health, neurodevelopmental disorders

Eligibility Criteria

5 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Intervention group I

    Intervention group II

    Arm Description

    6 sessions of intervention DFG starting at once (baseline). After DFG treatment as usual at Helsinki University hospital. The change between before the intervention (baseline) and after the intervention (3 months later) is being assessed.

    6 sessions of intervention DFG starting 3 months after baseline (3 months on waiting list). Between baseline and 3 months waiting list families were getting treatment as usual at Helsinki University hospital. The change between baseline - after 3 months waiting list (3 months from baseline)/ before the intervention - and after intervention (6 months from baseline) is being assessed. Also the difference between Intervention group I and II is assessed.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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
    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.
    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.
    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.
    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
    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
    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

    Full Information

    First Posted
    May 7, 2021
    Last Updated
    May 18, 2021
    Sponsor
    Diana Cavonius-Rintahaka
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04892992
    Brief Title
    Dialogical Family Guidance for Neurodevelopmental Disorders
    Acronym
    DFG
    Official Title
    Dialogical Family Guidance in Families With a Child With Neurodevelopmental Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 6, 2016 (Actual)
    Primary Completion Date
    December 31, 2018 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Diana Cavonius-Rintahaka

    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
    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 ).
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Family Dynamics
    Keywords
    Dialogical family guidance, family health, neurodevelopmental disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Intervention group I were delivered DFG immediately and Intervention group II were delivered DFG after three months.
    Masking
    Participant
    Masking Description
    Intervention group I were delivered DFG immediately, and Intervention group II were delivered DFG after three months.
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group I
    Arm Type
    Experimental
    Arm Description
    6 sessions of intervention DFG starting at once (baseline). After DFG treatment as usual at Helsinki University hospital. The change between before the intervention (baseline) and after the intervention (3 months later) is being assessed.
    Arm Title
    Intervention group II
    Arm Type
    Experimental
    Arm Description
    6 sessions of intervention DFG starting 3 months after baseline (3 months on waiting list). Between baseline and 3 months waiting list families were getting treatment as usual at Helsinki University hospital. The change between baseline - after 3 months waiting list (3 months from baseline)/ before the intervention - and after intervention (6 months from baseline) is being assessed. Also the difference between Intervention group I and II is assessed.
    Intervention Type
    Behavioral
    Intervention Name(s)
    DFG
    Primary Outcome Measure Information:
    Title
    The Family Function, Health and Social Support - scale (FAFHES)
    Description
    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.
    Time Frame
    Baseline measure before DFG family intervention starts
    Title
    The Family Function, Health and Social Support Scale (FAFHES)
    Description
    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.
    Time Frame
    3 months after baseline measure, when intervention is finished. Change is being assessed.
    Title
    The Family Function, Health and Social Support Scale (FAFHES)
    Description
    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.
    Time Frame
    6 months after baseline follow up. Change is being assessed.
    Secondary Outcome Measure Information:
    Title
    The Dialogical Family Guidance (DFG) - questionnaire
    Description
    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
    Time Frame
    3 months after baseline measure, when intervention is finished.
    Title
    The Strengths and Difficulties Questionnaire (SDQ)
    Description
    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.
    Time Frame
    Baseline measure before DFG family intervention starts
    Title
    The Strengths and Difficulties Questionnaire (SDQ)
    Description
    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.
    Time Frame
    3 months after baseline measure, when intervention is finished. Change is being assessed.
    Title
    The Strengths and Difficulties Questionnaire (SDQ)
    Description
    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.
    Time Frame
    6 months after baseline follow up. Change is being assessed.
    Title
    Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)
    Description
    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
    Time Frame
    Baseline measure before DFG family intervention starts
    Title
    Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)
    Description
    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
    Time Frame
    3 months after baseline measure, when intervention is finished. Change is being assessed.
    Title
    Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)
    Description
    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
    Time Frame
    6 months after baseline follow up. Change is being assessed.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Diana Cavonius-Rintahaka, MhSc
    Organizational Affiliation
    Tampere University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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