NCT03239990

Brief Summary

According to studies, approximately 20% of children having contact with child protection services have conduct disorder. Negative parenting can make this problem even worse. Research has shown Incredible Years Program to be one of the most effective programs to prevent and reduce child conduct problems. This study is an randomized controlled trial, which evaluates the suitability and effectiveness of group-based Incredible Years program in child protection and family support services. The aim of this study is to find out whether this intervention reduces children's psychiatric symptoms, especially conduct symptoms, increases positive parenting and positive interaction between parents and children, and reduces children's and parent's stress and increase well-being. The study will be carried out in 2015-2018. Overall 101 children and 120 parents participate in the study.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 15, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

December 13, 2021

Status Verified

November 1, 2021

Enrollment Period

2.2 years

First QC Date

June 15, 2017

Last Update Submit

November 29, 2021

Conditions

Keywords

Children's mental healthConduct disordersConduct problemsExternalizing problemsParental InterventionGroups based interventionFinlandSocial learning theoryCognitive-behavioral theory

Outcome Measures

Primary Outcomes (4)

  • Change in ECBI (Eyberg Child Behavior Checklist)

    Change of problem behavior measured by ECBI

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 0-3 months after the intervention is finished.

  • Change in CBCL (Child Behaviour Checklist) Externalizing scale

    Change of problem behavior measured by CBCL Externalizing scale

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 0-3 months after the intervention is finished.

  • Long term change in ECBI

    Long term change of problem behavior measured by ECBI

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.

  • Long term change in CBCL Externalizing scale

    Long term change of problem behavior measured by CBCL, Externalizing scale

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.

Secondary Outcomes (18)

  • Change in measure of executive functions (measured by KESKY questionnaire)

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 0-3 months after the intervention is finished.

  • Change in CBCL total scores

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 0-3 months after the intervention is finished.

  • Change in Dyadic Parent-Child Interaction measured by Dyadic Parent-Child Interaction Coding System

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 0-3 months after the intervention is finished.

  • Change in PPI, Parenting Practices Interview

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 0-3 months after the intervention is finished.

  • Change in PSI-4-SF, Parenting Stress Inventory, short version

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 0-3 months after the intervention is finished.

  • +13 more secondary outcomes

Other Outcomes (6)

  • Change in GHQ, General Health Questionnaire, for parent

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 0-3 months after the intervention is finished.

  • Change in SWEMWBS (Short version of Warwick-Edinburgh Mental Well-being Scale), Positive mental health questionnaire

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 0-3 months after the intervention is finished.

  • Change in Heart rate during rest

    Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 0-3 months after the intervention is finished.

  • +3 more other outcomes

Study Arms (2)

Incredible Years, Parent support

EXPERIMENTAL

Incredible Years, Parent group supported by home visiting includes the Incredible Years Parent Training Program, Preschool Basic version, with 18-20 group meetings. Four home visits are added to the program to support parents in practicing new skills and to provide individual practical consultation.

Behavioral: Incredible Years, Parent group supported by home visiting

Treatment as usual

NO INTERVENTION

The control group will receive treatment as usual

Interventions

Parents are taught to use positive and consistent strategies in reducing child misbehavior

Incredible Years, Parent support

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parents of the child are evaluated by child protection services to benefit from parenting support, or who receive special support for parenting
  • Child is between the ages 3-7 when entering the program
  • The child is living at home
  • Child has behavioral problems
  • Parents have the motivation to attend the groups
  • There is no unresolved acute child protection issue (child's basic needs and safety are not fulfilled).

You may not qualify if:

  • Parents have a mental health or substance abuse problem that prevents attending the group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Karjalainen P, Santalahti P, Aronen ET, Kiviruusu O. Parent- and teacher-reported long-term effects of parent training on child conduct problems in families with child protection and other support services: a randomized controlled trial. Child Adolesc Psychiatry Ment Health. 2021 Feb 11;15(1):7. doi: 10.1186/s13034-021-00358-6.

MeSH Terms

Conditions

Conduct Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Piia Karjalainen, M.ED

    Finnish Institute for Health and Welfare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomize Controlled Trial with intervention and control groups (TAU)
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

June 15, 2017

First Posted

August 4, 2017

Study Start

June 1, 2016

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

December 13, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share