Clinical trial NCT02250339: A Prospective Observational Study of Family-based Interventions for Children With Neuropsychiatric and/or Psychiatric Disorders
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ADHD
Asperger Syndrome
Child Behavior Disorders
Keywords: Child Mental Health
Parenting
Family Issues
Lead sponsor: Social Insurance Institution, Finland
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: University of Turku
First posted: 2014-09-26
Enrollment: 230
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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 description: 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 therapy) provided by a licensed therapist. Secondly, the family systemic and therapeutic approach has further influenced the development and implementation of specific licensed family-focused and empirically supported treatment program protocols (e.g. MST and MDFT). Thirdly, there are also specific behavioral and cognitive-behavioral parent training protocols available (e.g. PMTO and Triple P), which are considered a form of family-based approach. However, the rationale in parent training protocols stems more solely from social learning theory and interventions are typically delivered in a parent group format. It could be further argued that family-focused treatment protocols and parent training programs reflect the emergence of a so-called third-generation family therapeutic perspective by enhancing the need to establish evidence-based interventions through randomized controlled clinical trials. In addition to discussions above, family therapy is the most popular therapy approach among licensed psychotherapists working in the health care system in Finland. However, there is very little research on the effects of family-systemic interventions on the well-being of children with mental health problems and their families in Finnish health care settings.
3. Description of the interventions

   The multi-systemic and multicomponent family intervention for 5-12 year-old children with neuropsychiatric symptoms is based on the intervention program developed by the Health department of the Social Insurance Institution of Finland. In order to incorporate the best current practices and delivery formats, an independent expert panel of child psychiatry specialists from the Finnish University Hospitals was recruited in intervention development. Intervention feasibility and acceptability were further assessed by piloting work. At the present project, time-limited services (12 to 24 months) are provided in two different arms (i.e. separate intervention programs) referred to as LAKU and Etä-LAKU family intervention programs. Aims of the family intervention are to help children to strengthen their socio-emotional skills at home and in everyday life settings, help children and families to cope with their experiences, and strengthen interpersonal interaction among family members to overcome possibly difficult life situations, thoughts and emotions.

   The family therapeutic approach is the key intervention component. Family sessions are provided by a licensed family therapist and a co-worker who is also an experienced mental health care professional. Multi-systemic approach addresses the importance of individualized needs of children and families. This includes the work with other important social systems (e.g. child daycare and school). The multi-systemic approach also includes both visiting and monitoring the child in his/hers social environment as well as collaborative meetings together with the family and the child's significant others from daycare and school. The collaborative stance further requires that family workers attach assigned family consultants from the health care delivery system as part of the therapeutic system too. The multicomponent approach, for its part, is designed to provide different delivery formats for the families involved such as group meetings for parents. Other important delivery formats include one-to-one sessions with the child. The families are also given an opportunity to attend family weekends where they can meet other families who share similar life situations.

   LAKU and Etä-LAKU family intervention programs have some pertinent differences. The prior intervention program is provided in an 'urban' context and therapeutic sessions may take place flexibly both at a clinic and in the family's home. Etä-LAKU, however, is strictly an ecosystem-based family intervention program. It is tailored for families who live in rural parts of Finland with very limited health services available. The Etä-LAKU family intervention program does not include the delivery of parent group sessions either. The LAKU family program involves service providers and child mental health clinics in the Finnish towns of Helsinki, Kotka, Tampere and Oulu as well as their environs. The Etä-LAKU intervention program is provided in Lapland and Kainuu/Ylä-Savo environs.
4. Prospective observational clinical study

The centerpiece of the project will be a prospective observational study of 5-12 year-old children and their parents who attend family-systemic interventions in different practical settings. The observational study is further based on multisource (i.e. child, parent and teacher report) assessment design. The study has been approved by the Research Ethics Committee of the Hospital District of Southwest Finland and the Research Ethics Committee of the Kela research department. Study approval from the Hospital District of Southwest Finland is in process.

The control group consists of children and families attending family therapy. Time-limited family therapy (12 to 24 months) is provided via the Hospital District of Southwest Finland/Turku University Hospital's Child Psychiatry clinic (TYKS) and takes place in the town of Turku environs. All data will be collected in Finland and stored at the Research department of the Social Insurance Institution of Finland, located in Helsinki. Study measures will be administered in Finnish only.

The study design does not include randomization. However, it provides an opportunity to compare possible changes in child and parent well-being within and between three different and clinically relevant family intervention programs. Beyond this, key outcome variables are determined by giving the possibility to scrutinize intervention effectiveness more closely. The study design enables comparing the results from primary and secondary outcomes to those from nationally representative school- and population-based surveys conducted in Finland.

Eligibility 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

Primary outcomes:
measure: Child's Health Related Quality of Life questionnaire (HRQOL) - (KINDL-R)
timeFrame: 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
measure: Multisource Assessment of Children's Socioemotional Competence Scale (MASCS)
timeFrame: 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
measure: Parenting Self-Efficacy (PSE)
timeFrame: 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 outcomes:
measure: Finnish version of the Peer Network and Dyadic Loneliness Scale (PNDL)
timeFrame: 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
measure: Mental Health Inventory (MHI-5)
timeFrame: 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
Other outcomes:
measure: Parenting and Family Life Related Stress Measures
timeFrame: 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
measure: Satisfaction measures
timeFrame: Satisfaction will be measured at the end of an expected program average of 12-18 months & 24 months (when applicable)
Locations:
city: Helsinki
country: Finland
facility: Social Insurance Institution
Study officials:
affiliation: Research Department, Social Insurance Institution of Finland
name: Miika Vuori, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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