NCT06322511

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jan 2024Dec 2027

Study Start

First participant enrolled

January 2, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

4 years

First QC Date

March 7, 2024

Last Update Submit

March 13, 2024

Conditions

Keywords

neurodevelopmental disordersfamily healthfamily functionalityfamily support

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • DFG-questionnaire

    3 months

  • SDQ-p questionnaire (Strengths and difficulties regarding the child)

    0 months and 3 months

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Families with a child with clinical diagnosis within neurodevelopmental ambrella (ADHD, Tourette, Autism disorder, OCD...).
  • the child must be between 4-13 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki university hospital

Helsinki, 00029, Finland

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Diana Cavonius-Rintahaka, PhD

    Tampere University, Finland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Cavonius-Rintahaka, PhD

CONTACT

Anna Liisa Aho, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Families include both parents and children. Parents fill the questionnaires, but all family members attend on the meetings during the intervention (six meetings).
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 21, 2024

Study Start

January 2, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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.

Locations