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Trial record 2 of 3 for:    24581245 [PUBMED-IDS]

A Prospective Observational Study of Family-based Interventions for Children With Neuropsychiatric and/or Psychiatric Disorders

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ClinicalTrials.gov Identifier: NCT02250339
Recruitment Status : Unknown
Verified January 2016 by Social Insurance Institution, Finland.
Recruitment status was:  Active, not recruiting
First Posted : September 26, 2014
Last Update Posted : January 26, 2016
Sponsor:
Collaborators:
Paediatric Psychiatry Outpatient Clinic, TYKS Main Hospital
University of Turku
Information provided by (Responsible Party):
Social Insurance Institution, Finland

Brief Summary:
The purpose of this study is to examine the feasibility and the effects of family-based interventions for children (aged 5-12) with neuropsychiatric and psychiatric disorders in Finnish health care settings.

Condition or disease Intervention/treatment
ADHD Asperger Syndrome Child Behavior Disorders Other: LAKU family program Other: Etä-LAKU family program Other: Family therapy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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).
Study Start Date : December 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Group/Cohort Intervention/treatment
LAKU family program
Time-limited (12 or 24 months) intervention program for children (aged 5-12) with neuropsychiatric/psychiatric disorder(s). LAKU family program (12 month program) includes 35 family-based meetings. Families are also given an opportunity to attend two separate family weekends. In addition to this, parent group format may include 10 meetings at maximum. A 24-month-program will include 15 additional family-based meetings.
Other: LAKU family program
Multi-systemic and multicomponent family-based intervention program

Etä-LAKU family program
Time-limited (18 or 24 months) intervention program for children (aged 5-12) with neuropsychiatric/psychiatric disorder(s). Etä-LAKU family program (18 months) includes 35 family-based meetings and two separate family weekends. A 24-month-program will include 10 additional family-based meetings.
Other: Etä-LAKU family program
Ecosystem-based intervention for families living in rural parts of Finland

Family therapy
Time-limited (12 or 24 months) family therapeutic intervention for children (aged 5-12) with neuropsychiatric/psychiatric disorder(s). Family therapy intervention includes 15 (1-year program) or 30 (2-year program) family meetings.
Other: Family therapy
Treatment as usual (TAU)




Primary Outcome Measures :
  1. 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 ]
    KINDL-R is a generic instrument, which involves both child and parent reports.

  2. 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 ]
    The MASCS is developed on the of The School Social Behavior Scales (SSBS), and it measures child's prosocial and antisocial behaviour. Multisource assessment includes child, parent and teacher reports.

  3. 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 ]
    The PSE is a Finnish modification version of the Self-Efficacy for Parenting Tasks Index (SEPTI).


Secondary Outcome Measures :
  1. 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 ]
    PNDL measures lack of involvement in a social network and the absence of close dyadic friendships. Child report only.

  2. 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 ]
    To measure for Parent's Psychological Stress


Other Outcome Measures:
  1. Parenting and Family Life Related Stress Measures [ 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 ]
    Participants will be followed to measure psychological stress that stems from family related issues. Items are derived from Finnish family surveys conducted by the National Institute for Health and Welfare.

  2. Satisfaction measures [ Time Frame: Satisfaction will be measured at the end of an expected program average of 12-18 months & 24 months (when applicable) ]
    To measure intervention acceptability and feasibility



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The LAKU family program service is provided in Helsinki, Kotka, Tampere and Oulu environs. The Etä-LAKU intervention program is provided in Lapland and Kainuu/Ylä-Savo environs. Families are admitted to the programs by the child mental health clinics in the respective localities. The control group (treatment as usual) consists of children and families attending the family therapy fund by the Hospital District of Southwest Finland/Turku University Hospital's Child Psychiatry clinic (TYKS) and takes place in the Hospital District of Southwest Finland environs. Potential participants (i.e. the families admitted to the family-based intervention) will receive both oral and written information about the study and an invitation to volunteer. Both parents (when applicable) and child are advised to participate independently. Power analysis is utilized to ensure minimum necessary number of study participants. Anticipated sample sizes are: n=125 (LAKU), n=72 (Etä-LAKU), and n=33 (TAU group).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250339


Locations
Finland
Social Insurance Institution
Helsinki, Finland, 00381
Sponsors and Collaborators
Social Insurance Institution, Finland
Paediatric Psychiatry Outpatient Clinic, TYKS Main Hospital
University of Turku
Investigators
Principal Investigator: Miika Vuori, Ph.D. Research Department, Social Insurance Institution of Finland

Additional Information:
Publications:
Carr, A. (2014), The evidence base for family therapy and systemic interventions for child-focused problems. Journal of Family Therapy, 36: 107-157. doi: 10.1111/1467-6427.12032
Rambo A, West C, Schooley AL, Boyd TV. (Eds). Family therapy review: Contrasting contemporary models. New York: Taylor and Francis. 2013.
Rasheed JM, Rasheed MN, Marley JA. Family Therapy: Models and Techniques. London: SAGE.

Responsible Party: Social Insurance Institution, Finland
ClinicalTrials.gov Identifier: NCT02250339     History of Changes
Other Study ID Numbers: Perhe14
Kela ( Other Identifier: The Social Insurance Institution of Finland )
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by Social Insurance Institution, Finland:
Child Mental Health
Parenting
Family Issues

Additional relevant MeSH terms:
Disease
Mental Disorders
Problem Behavior
Asperger Syndrome
Child Behavior Disorders
Pathologic Processes
Behavioral Symptoms
Child Development Disorders, Pervasive
Neurodevelopmental Disorders