Family DynamicsDFGNCT04892992
Dialogical Family Guidance for Neurodevelopmental Disorders
A study testing DFG in people with Family Dynamics, run by Diana Cavonius-Rintahaka.
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. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Dynamics
- What is being tested?
- DFG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- the child is under 4 or over 16 years old
- parents do not have adequate Finnish language skills
About this study
Official title: Dialogical Family Guidance in Families With a Child With 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 ).
Read the 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.
- Conditions
- Family Dynamics
- Being tested
- DFG
- Keywords
- Dialogical family guidance, family health, neurodevelopmental disorders
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFGBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: DFG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months after baseline follow up. Change is being assessed.
Secondary outcomes (7)
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
Measured: 3 months after baseline measure, when intervention is finished.
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.
Measured: Baseline measure before DFG family intervention starts
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.
Measured: 3 months after baseline measure, when intervention is finished. Change is being assessed.
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.
Measured: 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)
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
Measured: Baseline measure before DFG family intervention starts
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
Measured: 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, 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
Measured: 6 months after baseline follow up. Change is being assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start6 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family DynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group I were delivered DFG immediately and Intervention group II were delivered DFG after three months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diana Cavonius-Rintahaka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diana Cavonius-Rintahaka, Tampere University
- Investigators
- Diana Cavonius-Rintahaka, MhSc, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892992
- Sponsor's protocol ID
- 106/13/03/03/2012
- Acronym
- DFG
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38580992
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialogical Family Guidance in Families With a Child With Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT04892992
- Acronym / sponsor ID
- DFG / 106/13/03/03/2012
- Conditions
- Family Dynamics
- Keywords
- Dialogical family guidance, family health, neurodevelopmental disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Diana Cavonius-RintahakaUniversity, hospital or other
- Study start
- 6 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention group I were delivered DFG immediately and Intervention group II were delivered DFG after three months.
| Arm | Type | Receives |
|---|---|---|
| Intervention group I | Experimental | Behavioral: DFG6 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. |
| Intervention group II | Experimental | Behavioral: DFG6 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. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- the child is under 4 or over 16 years old
- parents do not have adequate Finnish language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFG | Behavioural | Intervention group I, Intervention group II |
Primary outcome
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.
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.
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.
7 secondary outcomes
The Dialogical Family Guidance (DFG) - questionnaire
Time frame: 3 months after baseline measure, when intervention is finished.
The Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline measure before DFG family intervention starts
The Strengths and Difficulties Questionnaire (SDQ)
Time frame: 3 months after baseline measure, when intervention is finished. Change is being assessed.
The Strengths and Difficulties Questionnaire (SDQ)
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, 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, 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, 5-15 (FTF, Five - to - Fifteen)
Time frame: 6 months after baseline follow up. Change is being assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 38580992Cavonius-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.
- Individual participant dataSharing planned: No
Related trials for Family Dynamics
Not yet recruiting
Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families.
Eating Disorders, Body Image Dissatisfaction
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Recruiting
Family Intervention for Black Teens With Type 1 Diabetes
Type 1 Diabetes, Family Relations
Recruiting
Patient-clinical Linkages to Improve Trust and Engagement in Postpartum Healthcare
Family Dynamics, Trust in Healthcare System
Not yet recruiting
Addressing Relational and Communication Conflicts in Families With Adolescents.
Relational and Communication Conflicts Between Adolescents and Their Families
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Cavonius-Rintahaka, MhSc principal investigator
Tampere University
Questions about this trial
What is this clinical trial studying?
A study testing DFG in people with Family Dynamics, run by Diana Cavonius-Rintahaka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Family Function, Health and Social Support - scale (FAFHES) (time frame: Baseline measure before DFG family intervention starts). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04892992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.