|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
30 January 2023 |
|
Main ID: |
NCT02250339 |
|
Date of registration:
|
18/09/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Prospective Observational Study of Family-based Interventions for Children With Neuropsychiatric and/or Psychiatric Disorders
|
|
Scientific title:
|
Phase 2: A Prospective Observational Study of Feasibility and Tentative Effectiveness of Multi-Systemic and Multicomponent Family-Based Intervention for Families of Children With Neuropsychiatric and/or Psychiatric Disorder(s). |
|
Date of first enrolment:
|
December 2013 |
|
Target sample size:
|
230 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02250339 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Finland
| | | | | | | |
|
Contacts
|
|
Name:
|
Miika Vuori, Ph.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Research Department, Social Insurance Institution of Finland |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Child is 5-12 year-old at time of recruitment
- Child meets screening criteria for neuropsychiatric disorder (i.e. ADHD & Asperger
Syndrome)
- Child may also meet screening criteria for co-existing condition such as Behavior
Disorder
- Family situation is assessed by the health care professional (child psychiatrist) and
an intensive family-based intervention is further recommended
Exclusion Criteria:
- Child's psychiatric condition requires acute inpatient care
- Child's parent's alcohol and/or substance abuse requires acute treatment
- The progress is going on to correct the conditions that may lead to the child's
placement in out-of-home care
Age minimum:
5 Years
Age maximum:
12 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Asperger Syndrome
|
|
Child Behavior Disorders
|
|
ADHD
|
|
Intervention(s)
|
|
Other: Family therapy
|
|
Other: LAKU family program
|
|
Other: Etä-LAKU family program
|
|
Primary Outcome(s)
|
|
Child's Health Related Quality of Life questionnaire (HRQOL) - (KINDL-R)
[Time Frame: Participants will be followed to measure change from baseline to an expected average of 12-18 months & 24 months (when applicable) + 6 months post-intervention follow-up]
|
|
Parenting Self-Efficacy (PSE)
[Time Frame: Participants will be followed to measure change from baseline to an expected average of 12-18 months & 24 months (when applicable) + 6 months post-intervention follow-up]
|
|
Multisource Assessment of Children's Socioemotional Competence Scale (MASCS)
[Time Frame: Participants will be followed to measure change from baseline to an expected average of 12-18 months & 24 months (when applicable) + 6 months post-intervention follow-up]
|
|
Secondary Outcome(s)
|
|
Finnish version of the Peer Network and Dyadic Loneliness Scale (PNDL)
[Time Frame: Participants will be followed to measure change from baseline to an expected average of 12-18 months & 24 months (when applicable) + 6 months post-intervention follow-up]
|
|
Mental Health Inventory (MHI-5)
[Time Frame: Participants will be followed to measure change from baseline to an expected average of 12-18 months & 24 months (when applicable) + 6 months post-intervention follow-up]
|
|
Secondary ID(s)
|
|
Perhe14
|
|
Kela
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|