Family DynamicsDFG IINCT06322511
Dialogical Family Guidance PostDoc Study
A study testing Dialogical Family Guidance (DFG) in people with Family Dynamics and Family Relations, run by Tampere University at 1 site in Finland.
Trial summary
This new family intervention, called Dialogical Family Guidance (DFG) is developed to target family needs especially in families with a child with neurodevelopmental disorders. PhD study showed, that this intervention is functioning with this target group. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Family Dynamics, Family Relations, Family Support
- What is being tested?
- Dialogical Family Guidance (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
- 1 siteFinland
- Study dates
- 2 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Families with a child with clinical diagnosis within neurodevelopmental ambrella (ADHD, Tourette, Autism disorder, OCD...).
- the child must be between 4-13 years.
Who cannot join
- Families who do not understand finnish language (because they can not fill the questionnaires and professionals offering DFG are all finnish speaking). At least one parent needs to talk finnish.
- Families who are not motivated to receive DFG.
- Families who do not have a child with neurodevelopmental disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Helsinki university hospital
Helsinki, 00029
About this study
Official title: The Effectiveness of Dialogical Family Guidance in Families With a Child With Neurodevelopmental Disorders
This new family intervention, called Dialogical Family Guidance (DFG) is developed to target family needs especially in families with a child with neurodevelopmental disorders. PhD study showed, that this intervention is functioning with this target group. Participants (families) experienced that they got information, guidance to ordinary life and that the DFG-therapists were listening to them and above all, helping with individual problems and questions. DFG include six meetings and professionals need to attend on a 3-day long education before using this intervention.
Read the detailed description
Previous studies have highlighted the need for families with a child with neurodevelopmental disorders, to get guidance to daily life, information and also professionals who allow parents to share their own experiences, feelings and questions. Dialogical Family Guidance is developed to offer target families (participants) the help mentioned above. This study is a postdoctoral study to achieve more knowledge and understanding about DFG intervention. This Postdoctoral study is focusing on DFG effectivity offered to families with young children (5-7years). Researchers also want to receive information about DFG effectivity between different units inside and outside the university hospital. Comparation between different units using DFG is one goal with this postdoc study. These results may give researchers deeper understanding when deciding where (university hospital och basic level units) and for whom (childrens age?) DFG intervention is giving the most optimal help.
- Conditions
- Family Dynamics, Family Relations, Family Support
- Being tested
- Dialogical Family Guidance (DFG)
- Keywords
- neurodevelopmental disorders, family health, family functionality, family support
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialogical Family Guidance (DFG)Behavioural
DFG is family intervention including six meetings with family members. The individual needs and questions of each family are discussed and issues parents bring up are seemed as important.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | These families receive Dialogical family guidance, including six meetings (during 3 months) within the intervention manual proceedings. Parents fill the questionnaires before and after the intervention. Receives: Behavioral: Dialogical Family Guidance (DFG) |
| comparative group | No intervention | These families (parents in the family) give responses how they manage in ordinary life with their child with neurodevelopmental disorders. These families do not receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAFHES
FAFHES (Family Function, Health, and Social Support-questionnaire). The name of the questionnaire explains the content of this questionnaire that includes three sections: family functionality (19 items), family health (23 items), family support provided by professionals (21 items). Likert scale is used with ranging from 1-6 (1= disagree totally......6=I agree totally).
Measured: 0 months and 3 months
Secondary outcomes (2)
DFG-questionnaire
This questionnaire has been developed for DFG intervention including questions about the intervention sessions and themes. Items are included: e.g. questions about the amount and time consumed on DFG, content as a whole, practical advances, did your family get help, would you recommend this to other families. Likert scale from 1-5 is used. Two open ended questions in the end of the questionnaire is included.
Measured: 3 months
SDQ-p questionnaire (Strengths and difficulties regarding the child)
Measures changes in child's behavior. Includes 25 items with 3 point likert scale.
Measured: 0 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start2 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Families attending the study Group I: receives Dialogical Family Guidance intervention and they fill questionnaires before and after the intervention. Group II: Families do not receive Dialogical Family Guidance (but belong to the same focus group)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Cavonius-Rintahaka, Tampere University
- Investigators
- Diana Cavonius-Rintahaka, PhD, Principal investigator, Tampere University, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322511
- Sponsor's protocol ID
- HUS/7626/2023
- Acronym
- DFG II
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No information is shared regarding the families attending the study. Analyzed study results are shared by using results from scientific study protocols published in academic and international publications.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dialogical Family Guidance in Families With a Child With Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT06322511
- Acronym / sponsor ID
- DFG II / HUS/7626/2023
- Conditions
- Family Dynamics, Family Relations, Family Support
- Keywords
- neurodevelopmental disorders, family health, family functionality, family support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Mar 2024 (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.
This new family intervention, called Dialogical Family Guidance (DFG) is developed to target family needs especially in families with a child with neurodevelopmental disorders. PhD study showed, that this intervention is functioning with this target group. Participants (families) experienced that they got information, guidance to ordinary life and that the DFG-therapists were listening to them and above all, helping with individual problems and questions. DFG include six meetings and professionals need to attend on a 3-day long education before using this intervention.
Detailed description
Previous studies have highlighted the need for families with a child with neurodevelopmental disorders, to get guidance to daily life, information and also professionals who allow parents to share their own experiences, feelings and questions. Dialogical Family Guidance is developed to offer target families (participants) the help mentioned above. This study is a postdoctoral study to achieve more knowledge and understanding about DFG intervention. This Postdoctoral study is focusing on DFG effectivity offered to families with young children (5-7years). Researchers also want to receive information about DFG effectivity between different units inside and outside the university hospital. Comparation between different units using DFG is one goal with this postdoc study. These results may give researchers deeper understanding when deciding where (university hospital och basic level units) and for whom (childrens age?) DFG intervention is giving the most optimal help.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Families attending the study Group I: receives Dialogical Family Guidance intervention and they fill questionnaires before and after the intervention. Group II: Families do not receive Dialogical Family Guidance (but belong to the same focus group)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Dialogical Family Guidance (DFG)These families receive Dialogical family guidance, including six meetings (during 3 months) within the intervention manual proceedings. Parents fill the questionnaires before and after the intervention. |
| comparative group | No intervention | –These families (parents in the family) give responses how they manage in ordinary life with their child with neurodevelopmental disorders. These families do not receive the intervention. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Families with a child with clinical diagnosis within neurodevelopmental ambrella (ADHD, Tourette, Autism disorder, OCD...).
- the child must be between 4-13 years.
Key exclusion criteria (3 listed)
- Families who do not understand finnish language (because they can not fill the questionnaires and professionals offering DFG are all finnish speaking). At least one parent needs to talk finnish.
- Families who are not motivated to receive DFG.
- Families who do not have a child with neurodevelopmental disorders.
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 |
|---|---|---|
| Dialogical Family Guidance (DFG)DFG is family intervention including six meetings with family members. The individual needs and questions of each family are discussed and issues parents bring up are seemed as important. | Behavioural | Intervention group |
Primary outcome
FAFHES
Time frame: 0 months and 3 months
FAFHES (Family Function, Health, and Social Support-questionnaire). The name of the questionnaire explains the content of this questionnaire that includes three sections: family functionality (19 items), family health (23 items), family support provided by professionals (21 items). Likert scale is used with ranging from 1-6 (1= disagree totally......6=I agree totally).
2 secondary outcomes
DFG-questionnaire
Time frame: 3 months
SDQ-p questionnaire (Strengths and difficulties regarding the child)
Time frame: 0 months and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No. No information is shared regarding the families attending the study. Analyzed study results are shared by using results from scientific study protocols published in academic and international publications.
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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.
Diana Cavonius-Rintahaka, PhD principal investigator
Tampere University, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialogical Family Guidance (DFG) in people with Family Dynamics and Family Relations, run by Tampere University at 1 site in Finland.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Cavonius-Rintahaka, PhD (+358 405551511, diana.cavonius@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAFHES (time frame: 0 months and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2024.