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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06322511
Other study ID # HUS/7626/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2024
Est. completion date December 31, 2027

Study information

Verified date March 2024
Source Tampere University
Contact Diana Cavonius-Rintahaka, PhD
Phone +358 405551511
Email diana.cavonius@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 4 Years to 13 Years
Eligibility 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 Design


Intervention

Behavioral:
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.

Locations

Country Name City State
Finland Helsinki university hospital Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 0 months and 3 months
Secondary 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. 3 months
Secondary SDQ-p questionnaire (Strengths and difficulties regarding the child) Measures changes in child's behavior. Includes 25 items with 3 point likert scale. 0 months and 3 months
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