- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06322511
Dialogical Family Guidance PostDoc Study (DFG II)
March 13, 2024 updated by: Diana Cavonius-Rintahaka, Tampere University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Diana Cavonius-Rintahaka, PhD
- Phone Number: +358 405551511
- Email: diana.cavonius@gmail.com
Study Contact Backup
- Name: Anna Liisa Aho, PhD
- Phone Number: +358 401901448
- Email: annaliisa.aho@tuni.fi
Study Locations
-
-
-
Helsinki, Finland, 00029
- Recruiting
- Helsinki University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Families with a child with clinical diagnosis within neurodevelopmental ambrella (ADHD, Tourette, Autism disorder, OCD...).
- the child must be between 4-13 years.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
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.
|
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.
|
|
No Intervention: comparative group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
0 months and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DFG-questionnaire
Time Frame: 3 months
|
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.
|
3 months
|
|
SDQ-p questionnaire (Strengths and difficulties regarding the child)
Time Frame: 0 months and 3 months
|
Measures changes in child's behavior.
Includes 25 items with 3 point likert scale.
|
0 months and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Diana Cavonius-Rintahaka, PhD, Tampere University, Finland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
March 7, 2024
First Submitted That Met QC Criteria
March 13, 2024
First Posted (Actual)
March 21, 2024
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 13, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUS/7626/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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