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Conduct Disorders in ChildrenNCT03239990

Group-based Parenting Program to Reduce Child Conduct Disorder Symptoms in Finland

A study testing Incredible Years, Parent group supported by home visiting in people with Conduct Disorders in Children, run by Finnish Institute for Health and Welfare.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 7 yearsHealthy volunteers can take part
Conditions the study is for
Conduct Disorders in Children
What is being tested?
Incredible Years, Parent group supported by home visiting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
No sites listed yet
Study dates
1 Jun 2016to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

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

About this study

Official title: Group-based Parenting Program "Incredible Years" to Reduce Child Conduct Disorder Symptoms in Families With Child Protection and Other Family Support Services in Finland

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.

Read the detailed description
  1. Introduction Parenting skills and home environment play a major role in children's development and safety, especially in early childhood. Studies have shown that maltreating parents have poor child management techniques, high levels of hostile feelings, reduced emotional responsiveness and escalated verbal aggression. It is apparent that large number of parents receiving child protection services are engaged in parental behaviors that do not decrease child's problems, but instead may be harmful to their children. Since over 80 000 of the children receiving support from child protection services in Finland remain in their homes, the need of effective methods to support parenting is evident. Several randomized trials have shown that parent management training programs, which are based primarily on social learning theory, cognitive-behavioral theory, and attachment theory, effectively improve parenting skills, parents' mental health and child conduct problems. These programs build on social learning theory according to which parents model the appropriate behavior to their children. Behavioristic principles, however, include methods of prompting children's positive behavior. Ideas based on cognitive theory help parents change their conceptions of the child and his/her problematic behavior and coaches them to use problem solving and anger management skills. The basis of attachment theory is that when a sensitive and safe attachment has developed between the child and the caretaker, it helps a child feel safe and builds his/her positive perception of different situations. Incredible Years Parent Training Program(IY) is one of the most researched programs and has been found to be effective in different countries and contexts, for example among high-risk, disadvantaged, and maltreating families and also among foster carers . However, only a few studies have been made in the context of child protection services or with maltreated children. The IY program is group-based, focuses on building support networks and decreasing isolation, and has a format designed to reduce stigma, and increase parental participation and engagement. It emphasizes individual goal-setting and a self-reflective learning style, as well as intensive behavior practice and rehearsal methods with other parents and a positive, collaborative relationship between group leaders and parents. For the previous reasons it may be particularly relevant to families with child protection services contact and should be thoroughly researched.
  2. Aims The main study question is: Does the group based, intensive Incredible Years Parent Management Training reduce children's (age 3-7) (sub)clinically significant behavioral problems? The other study questions are: Does Incredible Years Parent Management Training
  • increase positive parenting?
  • increase positive interaction between parents and children?
  • reduce children's (age 3-7) other psychiatric symptoms?
  • reduce children's and parent's stress?
  • increase parent's well-being?
  1. Study Design Randomized controlled trial design will be used (RCT). Participants are 3-7 year old children (index children, n=101) with behavioral problems and their parents who are currently clients of child protection services, other special support services for families or families who are clients of family centers or need support just for their parenting. Parents and children were randomized before the baseline measurements to the intervention group or treatment as usual / waiting list condition. The intervention program is Incredible Years Parent Training (Preschool Basic), with 20 parent group meetings, including 4 home visits. Children themselves do not participate in any intervention. Based on earlier studies the intervention effects of parent management training is mediated by changed parenting practices towards children. The measuring points are pre, post and 1 year. The study will be carried out in 2015-2018. Intervention Participants will attend the Incredible Years Parent Training Program, Preschool Basic version, with 18-20 group meetings. The program is based mainly on cognitive-behavioral and social learning theories. The goal of the group is to enhance and support parenting skills, increase knowledge of child development, improve child's positive behavior and parent-child interaction. Parents are taught to use more positive and consistent strategies in reducing child misbehavior by watching dvd's, rehearsing and group discussions. Groups consist of 10-12 parents and they get together weekly for app. 2-2,5 hours at a time. Four home visits are added to the program to support parents in practicing new skills and to provide individual practical consultation. Also weekly phone calls are being made to the parents, as part of normal procedure of the program. Parents will be interviewed before starting the intervention to explain it fully. The intervention groups will start in fall 2016 or beginning of 2017. In each group there will be three trained group leaders, of which two are from family counselling services and one a family worker from child protection services, who also conducts family visits. Program fidelity The group leaders will receive supervision from certified peer coach every three weeks and once from a mentor during the duration of the groups. Group leaders will fill out check lists and self-evaluations after every group meeting. Also evaluations from parents after every group meeting will be gathered.
  2. Ethics

Parents and children are participating voluntarily in the research. Participants of the intervention group are given concrete information and training about positive parenting methods in a supportive and positive peer group by trained leaders. The participants of the control group can access all the other services and support they are entitled to, other than the intervention program being researched. The restrain and discomfort caused to participants can be considered minor.

Families participating the study have been interviewed and their willingness to participate have been asked beforehand. The group leaders of the intervention will interview the participants of the intervention group and tell about the intervention. The participants of the control group have a possibility access the next available parent group in the community.

Parents participating the research have at any time a right to withdraw from the research. Confidentiality will be taken care of.

Being tested
Incredible Years, Parent group supported by home visiting
Keywords
Children's mental health, Conduct disorders, Conduct problems, Externalizing problems, Parental Intervention, Groups based intervention, Finland, Social learning theory, Cognitive-behavioral theory
Medical subject headings
Conduct Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incredible Years, Parent group supported by home visitingBehavioural

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

Study groups in NCT03239990
Study groupRoleWhat they receive
Incredible Years, Parent supportExperimentalIncredible 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.
Receives: Behavioral: Incredible Years, Parent group supported by home visiting
Treatment as usualNo interventionThe control group will receive treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in ECBI (Eyberg Child Behavior Checklist)

    Change of problem behavior measured by ECBI

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

  2. Change in CBCL (Child Behaviour Checklist) Externalizing scale

    Change of problem behavior measured by CBCL Externalizing scale

    Measured: 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. Long term change in ECBI

    Long term change of problem behavior measured by ECBI

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

  4. Long term change in CBCL Externalizing scale

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

    Measured: 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)
  1. Change in measure of executive functions (measured by KESKY questionnaire)

    Change of a child's executive functions (including, attention, impulsivity and motor restlessness measured by KESKY questionnaire)

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

  2. Change in CBCL total scores

    Change in a child's psychiatric problems measured by CBCL total scores

    Measured: 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. Change in Dyadic Parent-Child Interaction measured by Dyadic Parent-Child Interaction Coding System

    Parent-child interaction quality evaluated by coding 10 minutes videos of child-led play and parent-led play

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

  4. Change in PPI, Parenting Practices Interview

    Parent's self evaluation of his/her parenting practices

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

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

    Parent's self evaluation of his/her parenting related stress

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

  6. Change in the Marshmallow test

    Child's patience to resist temptation to eat a marshmallow candy

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

  7. Change in child's risk taking behavior in a gambling task

    Child's tendency to take risks in a gambling task to win candies

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

  8. Change in child's trust to another child

    Trust Game (Surprise Bag Task) to evaluate does a child trust she/he gets something back if she/he gives a surprise bag to an other child.

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

  9. Change in Dictator game for children

    Altruism, how much the child is willing to give stickers to another child, who doesn't have any.

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

  10. Long term change in measure of executive functions (measured by KESKY questionnaire)

    Change of a child's executive functions (including attention, impulsivity and motor restlessness measured by KESKY questionnaire)

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

  11. Long term change in CBCL total scores

    Change in a child's psychiatric problems measured by CBCL total scores

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

  12. Long term change in Dyadic Parent-Child Interaction measured by Dyadic Parent-Child Interaction Coding System

    Parent-child interaction quality evaluated by coding 10 minutes videos of child-led play and parent-led play

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

  13. Long term change in PPI, Parenting Practices Interview

    Parent's self evaluation of his/her parenting practices

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

  14. Long term change in PSI-4-SF, Parenting Stress Inventory, short version

    Parent's self evaluation of his/her parenting related stress

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

  15. Long term change in the Marshmallow test

    Child's patience to resist temptation to eat a marshmallow candy

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

  16. Long term change in child's risk taking behavior in a gambling task

    Child's tendency to take risks in a gambling task to win candies

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

  17. Long term change in child's trust to another child

    Trust Game (Surprise Bag Task) to evaluate does a child trust she/he gets something back if she/he gives a surprise bag to an other child.

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

  18. Long term change in Dictator game for children

    Altruism, how much the child is willing to give stickers to another child, who doesn't have any.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2017
  2. Study start1 Jun 2016
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomize Controlled Trial with intervention and control groups (TAU)
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03239990
Sponsor's protocol ID
THL/1059/6.02.01/2015
Status last verified
Nov 2021
First submitted
15 Jun 2017
Last updated
13 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33573694

Questions about this trial

What is this clinical trial studying?

A study testing Incredible Years, Parent group supported by home visiting in people with Conduct Disorders in Children, run by Finnish Institute for Health and Welfare.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in ECBI (Eyberg Child Behavior Checklist) (time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 0-3 months after the intervention is finished.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03239990, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.

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