- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02250339
A Prospective Observational Study of Family-based Interventions for Children With Neuropsychiatric and/or Psychiatric Disorders
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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.
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.
- 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland, 00381
- Social Insurance Institution
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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.
|
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.
|
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.
|
Treatment as usual (TAU)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
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.
|
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
|
The PSE is a Finnish modification version of the Self-Efficacy for Parenting Tasks Index (SEPTI).
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
To measure for Parent's Psychological Stress
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
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
|
Satisfaction will be measured at the end of an expected program average of 12-18 months & 24 months (when applicable)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Miika Vuori, Ph.D., Research Department, Social Insurance Institution of Finland
Publications and helpful links
General Publications
- Littell JH, Popa M, Forsythe B. Multisystemic Therapy for social, emotional, and behavioral problems in youth aged 10-17. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD004797. doi: 10.1002/14651858.CD004797.pub3.
- Barlow J, Smailagic N, Huband N, Roloff V, Bennett C. Group-based parent training programmes for improving parental psychosocial health. Cochrane Database Syst Rev. 2014 May 17;(5):CD002020. doi: 10.1002/14651858.CD002020.pub4.
- Gross DA, Belcher HM, Ofonedu ME, Breitenstein S, Frick KD, Chakra B. Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families? Trials. 2014 Mar 1;15:70. doi: 10.1186/1745-6215-15-70.
- Lee PC, Niew WI, Yang HJ, Chen VC, Lin KC. A meta-analysis of behavioral parent training for children with attention deficit hyperactivity disorder. Res Dev Disabil. 2012 Nov-Dec;33(6):2040-9. doi: 10.1016/j.ridd.2012.05.011. Epub 2012 Jun 29.
- Charach A, Carson P, Fox S, Ali MU, Beckett J, Lim CG. Interventions for preschool children at high risk for ADHD: a comparative effectiveness review. Pediatrics. 2013 May;131(5):e1584-604. doi: 10.1542/peds.2012-0974. Epub 2013 Apr 1.
- Zwi M, Jones H, Thorgaard C, York A, Dennis JA. Parent training interventions for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 5 to 18 years. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD003018. doi: 10.1002/14651858.CD003018.pub3.
- Reyno SM, McGrath PJ. Predictors of parent training efficacy for child externalizing behavior problems--a meta-analytic review. J Child Psychol Psychiatry. 2006 Jan;47(1):99-111. doi: 10.1111/j.1469-7610.2005.01544.x.
- Lundahl B, Risser HJ, Lovejoy MC. A meta-analysis of parent training: moderators and follow-up effects. Clin Psychol Rev. 2006 Jan;26(1):86-104. doi: 10.1016/j.cpr.2005.07.004. Epub 2005 Nov 8.
- Shepperd S, Doll H, Gowers S, James A, Fazel M, Fitzpatrick R, Pollock J. Alternatives to inpatient mental health care for children and young people. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006410. doi: 10.1002/14651858.CD006410.pub2.
- 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
- Dunst CJ, Trivette CM, Hamby DW. Meta-analysis of family-centered helpgiving practices research. Ment Retard Dev Disabil Res Rev. 2007;13(4):370-8. doi: 10.1002/mrdd.20176.
- Robin AL. Family therapy for adolescents with ADHD. Child Adolesc Psychiatr Clin N Am. 2014 Oct;23(4):747-56. doi: 10.1016/j.chc.2014.06.001. Epub 2014 Aug 8.
- Kolko DJ, Campo J, Kilbourne AM, Hart J, Sakolsky D, Wisniewski S. Collaborative care outcomes for pediatric behavioral health problems: a cluster randomized trial. Pediatrics. 2014 Apr;133(4):e981-92. doi: 10.1542/peds.2013-2516. Epub 2014 Mar 24.
- Karst JS, Van Hecke AV. Parent and family impact of autism spectrum disorders: a review and proposed model for intervention evaluation. Clin Child Fam Psychol Rev. 2012 Sep;15(3):247-77. doi: 10.1007/s10567-012-0119-6.
- Matson JL, Mahan S, LoVullo SV. Parent training: a review of methods for children with developmental disabilities. Res Dev Disabil. 2009 Sep-Oct;30(5):961-8. doi: 10.1016/j.ridd.2009.01.009. Epub 2009 Feb 25.
- Patterson SY, Smith V, Mirenda P. A systematic review of training programs for parents of children with autism spectrum disorders: single subject contributions. Autism. 2012 Sep;16(5):498-522. doi: 10.1177/1362361311413398. Epub 2012 Jan 16.
- Danckaerts M, Sonuga-Barke EJ, Banaschewski T, Buitelaar J, Dopfner M, Hollis C, Santosh P, Rothenberger A, Sergeant J, Steinhausen HC, Taylor E, Zuddas A, Coghill D. The quality of life of children with attention deficit/hyperactivity disorder: a systematic review. Eur Child Adolesc Psychiatry. 2010 Feb;19(2):83-105. doi: 10.1007/s00787-009-0046-3. Epub 2009 Jul 26.
- Cappe E, Wolff M, Bobet R, Adrien JL. Quality of life: a key variable to consider in the evaluation of adjustment in parents of children with autism spectrum disorders and in the development of relevant support and assistance programmes. Qual Life Res. 2011 Oct;20(8):1279-94. doi: 10.1007/s11136-011-9861-3. Epub 2011 Feb 12.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Perhe14
- Kela (Other Identifier: The Social Insurance Institution of Finland)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ADHD
-
Okinawa Institute of Science and Technology Graduate...Japan society for the promotion of science; Miyazaki International CollegeRecruiting
-
King's College LondonSouth London and Maudsley NHS Foundation TrustNot yet recruiting
-
Universidad de GranadaNot yet recruiting
-
Izmir Katip Celebi UniversityDokuz Eylul UniversityNot yet recruiting
-
Seattle Children's HospitalNational Institute of Mental Health (NIMH); University of WashingtonRecruiting
-
University of California, DavisRecruiting
-
Chen LiRecruiting
-
Region SyddanmarkRecruiting
-
Hugo W. Moser Research Institute at Kennedy Krieger...Active, not recruiting
Clinical Trials on LAKU family program
-
Sorlandet Hospital HFCompleted
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)CompletedAnxiety DisorderCanada
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)CompletedPediatric Disruptive Behaviour DisorderCanada
-
Rutgers, The State University of New JerseyAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingParenting | Health Behavior | Language Development | LiteracyUnited States
-
IRCCS Centro San Giovanni di Dio FatebenefratelliAzienda Socio Sanitaria Territoriale del Garda; Department of Clinical Neurosciences... and other collaboratorsCompleted
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedPreDiabetes | Type 2 Diabetes | Obesity, Childhood | Overweight and Obesity | Lifestyle, Healthy | Overweight, ChildhoodUnited States
-
Matthew ModesIcahn School of Medicine at Mount SinaiRecruitingCritical Illness | Respiratory Failure | Physician-Patient Relations | Family SupportUnited States
-
Universitat Jaume IUniversity of ValenciaNot yet recruiting
-
Boston CollegeChristian Alliance for Orphans; Helping Children Worldwide; Child Reintegration...Active, not recruitingEvaluation of a Family Strengthening Program Evaluation in Sierra Leone to Prevent Family SeparationParent-Child Relations | Parenting | Emotion Regulation | Economic ProblemsSierra Leone
-
Human Development Research Foundation, PakistanAutism Speaks; World Health Organization; Grand Challenges Canada; University of... and other collaboratorsCompletedNeurodevelopmental Disorders | Developmental DisabilitiesPakistan