Dialogical Family Guidance for Neurodevelopmental Disorders

NCT04892992 | Completed

• 1 other identifier: 106/13/03/03/2012
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 ).

Conditions

Family Dynamics

Keywords

Dialogical family guidance; family health; neurodevelopmental disorders

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

• 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 Outcomes (7)

• The Dialogical Family Guidance (DFG) - questionnaire

  3 months after baseline measure, when intervention is finished.

• The Strengths and Difficulties Questionnaire (SDQ)

  Baseline measure before DFG family intervention starts

• The Strengths and Difficulties Questionnaire (SDQ)

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

• The Strengths and Difficulties Questionnaire (SDQ)

  6 months after baseline follow up. Change is being assessed.

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

  Baseline measure before DFG family intervention starts

Study Arms (2)

Intervention group I

EXPERIMENTAL

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.

Behavioral: DFG

Intervention group II

EXPERIMENTAL

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.

Behavioral: DFG

Interventions

DFG BEHAVIORAL

Intervention group I; Intervention group II

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• the child is under 4 or over 16 years old
• parents do not have adequate Finnish language skills

Sponsors & Collaborators

• Diana Cavonius-Rintahaka: lead

Related Publications (1)

• Cavonius-Rintahaka D, Roos M, Aho AL. The effectiveness of a dialogical family guidance intervention regarding child treatment response in families with a child with neurodevelopmental disorders. BMC Psychol. 2024 Apr 5;12(1):189. doi: 10.1186/s40359-024-01706-9.

  PMID: 38580992 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Diana Cavonius-Rintahaka, MhSc

  Tampere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Intervention group I were delivered DFG immediately, and Intervention group II were delivered DFG after three months.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD candidate

Model Details: Intervention group I were delivered DFG immediately and Intervention group II were delivered DFG after three months.

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 19, 2021
• Study Start: January 6, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share