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Completed

NCT Number: NCT04892992

Dialogical Family Guidance for Neurodevelopmental Disorders

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 ).

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Key information

Conditions

Family Dynamics Mental Disorders Neurodevelopmental Disorders

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DFG

Behavioral

Primary outcomes

  1. The Family Function, Health and Social Support - scale (FAFHES)

    Time frame: Baseline measure before DFG family intervention starts

    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.

  2. The Family Function, Health and Social Support Scale (FAFHES)

    Time frame: 3 months after baseline measure, when intervention is finished. Change is being assessed.

    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. The Family Function, Health and Social Support Scale (FAFHES)

    Time frame: 6 months after baseline follow up. Change is being assessed.

    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 outcomes

  1. The Dialogical Family Guidance (DFG) - questionnaire

    Time frame: 3 months after baseline measure, when intervention is finished.

    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

  2. The Strengths and Difficulties Questionnaire (SDQ)

    Time frame: Baseline measure before DFG family intervention starts

    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. The Strengths and Difficulties Questionnaire (SDQ)

    Time frame: 3 months after baseline measure, when intervention is finished. Change is being assessed.

    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.

  4. The Strengths and Difficulties Questionnaire (SDQ)

    Time frame: 6 months after baseline follow up. Change is being assessed.

    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.

  5. Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)

    Time frame: Baseline measure before DFG family intervention starts

    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. Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)

    Time frame: 3 months after baseline measure, when intervention is finished. Change is being assessed.

    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

  7. Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)

    Time frame: 6 months after baseline follow up. Change is being assessed.

    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

Sponsors and collaborators

Lead sponsor

Diana Cavonius-Rintahaka

Other

Registry information

Official study title

Dialogical Family Guidance in Families With a Child With Neurodevelopmental Disorders

Acronym: DFG

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 19, 2021
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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