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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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/

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.

Detailed Summary:

  1. Introduction

    The role of the Social Insurance Institution of Finland (Kela) is to complement publicly funded Finnish health care delivery system. In 2003, the Finnish Ministry of Social Affairs and Health further defined that Kela fund mental health services for children under 16 years old should incorporate family oriented psychological counselling and multicomponent rehabilitation. The purpose of the present prospective observational study is to examine the feasibility and tentative effectiveness of a multi-systemic and multicomponent family interventions for 5−12 year-old children with neuropsychiatric symptoms. The present study design is defined by the following key characteristics: (a) it comprises the comparison of three clinically relevant interventions based on family therapeutic activities; (b) it involves a diverse population of participants from heterogeneous practice settings; and (c) intervention outcomes are defined relatively broadly. All study participants will be recruited in Finland. The research is also conducted in Finland by the Finnish research consortium. The research project is funded by the Health department of the Social Insurance Institution of Finland.

  2. Effectiveness of family-systemic interventions for children with mental health problems

    Empirical evidence supports the effectiveness of family-systemic and family-based interventions for children who may suffer from, for example, socio-emotional and developmental problems that relate to neuropsychiatric disorders such as ADHD and Autism Spectrum Disorder. Family-systemic interventions may, firstly, refer to a more traditional and distinct method of psychotherapy (i.e. family t
    Sponsor: Social Insurance Institution, Finland

    Current Primary Outcome:

    • 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.
    • 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.
    • 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).


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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.
    • 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


    Original Secondary Outcome: Same as current

    Information By: Social Insurance Institution, Finland

    Dates:
    Date Received: September 18, 2014
    Date Started: December 2013
    Date Completion: December 2018
    Last Updated: January 25, 2016
    Last Verified: January 2016