Clinical trial NCT04892992: Dialogical Family Guidance for Neurodevelopmental Disorders
Official title: Dialogical Family Guidance in Families With a Child With Neurodevelopmental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Dynamics
Keywords: Dialogical family guidance
family health
neurodevelopmental disorders
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group I were delivered DFG immediately and Intervention group II were delivered DFG after three months.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Family Function, Health and Social Support - scale (FAFHES)
timeFrame: Baseline measure before DFG family intervention starts
measure: The Family Function, Health and Social Support Scale (FAFHES)
timeFrame: 3 months after baseline measure, when intervention is finished. Change is being assessed.
measure: The Family Function, Health and Social Support Scale (FAFHES)
timeFrame: 6 months after baseline follow up. Change is being assessed.
Secondary outcomes:
measure: The Dialogical Family Guidance (DFG) - questionnaire
timeFrame: 3 months after baseline measure, when intervention is finished.
measure: The Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline measure before DFG family intervention starts
measure: The Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 3 months after baseline measure, when intervention is finished. Change is being assessed.
measure: The Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 6 months after baseline follow up. Change is being assessed.
measure: Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)
timeFrame: Baseline measure before DFG family intervention starts
measure: Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)
timeFrame: 3 months after baseline measure, when intervention is finished. Change is being assessed.
measure: Parent Questionnaire for Evaluation of Development and Behaviour in 5-15-year old Children, 5-15 (FTF, Five - to - Fifteen)
timeFrame: 6 months after baseline follow up. Change is being assessed.
Other outcomes:
Locations:
Study officials:
affiliation: Tampere University
name: Diana Cavonius-Rintahaka, MhSc
role: PRINCIPAL_INVESTIGATOR
References: