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

NCT02250339 | Completed

• 2 other identifiers: Perhe14Kela
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Asperger Syndrome; Child Behavior Disorders

Keywords

Child Mental Health; Parenting; Family Issues

Outcome Measures

Primary Outcomes (3)

• Child's Health Related Quality of Life questionnaire (HRQOL) - (KINDL-R)

  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)

  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)

  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 Outcomes (2)

• Finnish version of the Peer Network and Dyadic Loneliness Scale (PNDL)

  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)

  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 (2)

• Parenting and Family Life Related Stress Measures

  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

  Satisfaction will be measured at the end of an expected program average of 12-18 months & 24 months (when applicable)

Study Arms (3)

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

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

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

Interventions

LAKU family program OTHER

Multi-systemic and multicomponent family-based intervention program

LAKU family program

Etä-LAKU family program OTHER

Ecosystem-based intervention for families living in rural parts of Finland

Etä-LAKU family program

Family therapy OTHER

Treatment as usual (TAU)

Family therapy

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Social Insurance Institution, Finland: lead
• Turku University Hospital: collaborator
• University of Turku: collaborator

Study Sites (1)

Social Insurance Institution

Helsinki, 00381, Finland

Location

Related Publications (20)

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  PMID: 24838729 BACKGROUND

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• 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.

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  PMID: 23545375 BACKGROUND

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  PMID: 22161373 BACKGROUND

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  PMID: 16405646 BACKGROUND

• 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.

  PMID: 16280191 BACKGROUND

• 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;2009(2):CD006410. doi: 10.1002/14651858.CD006410.pub2.

  PMID: 19370634 BACKGROUND

• 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

  BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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  PMID: 22250194 BACKGROUND

• 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.

  PMID: 19633992 BACKGROUND

• 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.

  PMID: 21312064 BACKGROUND

• Rambo A, West C, Schooley AL, Boyd TV. (Eds). Family therapy review: Contrasting contemporary models. New York: Taylor and Francis. 2013.

  BACKGROUND

• Rasheed JM, Rasheed MN, Marley JA. Family Therapy: Models and Techniques. London: SAGE.

  BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Asperger Syndrome; Child Behavior Disorders

Interventions

Family Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Miika Vuori, Ph.D.

  Research Department, Social Insurance Institution of Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 26, 2014
• Study Start: December 1, 2013
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: January 19, 2023

Record last verified: 2016-01

Locations

FI (1)