<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03239990</url>
  </required_header>
  <id_info>
    <org_study_id>THL/1059/6.02.01/2015</org_study_id>
    <nct_id>NCT03239990</nct_id>
  </id_info>
  <brief_title>Group-based Parenting Program to Reduce Child Conduct Disorder Symptoms in Finland</brief_title>
  <official_title>Group-based Parenting Program &quot;Incredible Years&quot; to Reduce Child Conduct Disorder Symptoms in Families With Child Protection and Other Family Support Services in Finland</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Finnish Institute for Health and Welfare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Finnish Institute for Health and Welfare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      According to studies, approximately 20% of children having contact with child protection&#xD;
      services have conduct disorder. Negative parenting can make this problem even worse. Research&#xD;
      has shown Incredible Years Program to be one of the most effective programs to prevent and&#xD;
      reduce child conduct problems. This study is an randomized controlled trial, which evaluates&#xD;
      the suitability and effectiveness of group-based Incredible Years program in child protection&#xD;
      and family support services. The aim of this study is to find out whether this intervention&#xD;
      reduces children's psychiatric symptoms, especially conduct symptoms, increases positive&#xD;
      parenting and positive interaction between parents and children, and reduces children's and&#xD;
      parent's stress and increase well-being. The study will be carried out in 2015-2018. Overall&#xD;
      101 children and 120 parents participate in the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Introduction Parenting skills and home environment play a major role in children's&#xD;
           development and safety, especially in early childhood. Studies have shown that&#xD;
           maltreating parents have poor child management techniques, high levels of hostile&#xD;
           feelings, reduced emotional responsiveness and escalated verbal aggression. It is&#xD;
           apparent that large number of parents receiving child protection services are engaged in&#xD;
           parental behaviors that do not decrease child's problems, but instead may be harmful to&#xD;
           their children. Since over 80 000 of the children receiving support from child&#xD;
           protection services in Finland remain in their homes, the need of effective methods to&#xD;
           support parenting is evident.&#xD;
&#xD;
           Several randomized trials have shown that parent management training programs, which are&#xD;
           based primarily on social learning theory, cognitive-behavioral theory, and attachment&#xD;
           theory, effectively improve parenting skills, parents' mental health and child conduct&#xD;
           problems. These programs build on social learning theory according to which parents&#xD;
           model the appropriate behavior to their children. Behavioristic principles, however,&#xD;
           include methods of prompting children's positive behavior. Ideas based on cognitive&#xD;
           theory help parents change their conceptions of the child and his/her problematic&#xD;
           behavior and coaches them to use problem solving and anger management skills. The basis&#xD;
           of attachment theory is that when a sensitive and safe attachment has developed between&#xD;
           the child and the caretaker, it helps a child feel safe and builds his/her positive&#xD;
           perception of different situations.&#xD;
&#xD;
           Incredible Years Parent Training Program(IY) is one of the most researched programs and&#xD;
           has been found to be effective in different countries and contexts, for example among&#xD;
           high-risk, disadvantaged, and maltreating families and also among foster carers .&#xD;
           However, only a few studies have been made in the context of child protection services&#xD;
           or with maltreated children.&#xD;
&#xD;
           The IY program is group-based, focuses on building support networks and decreasing&#xD;
           isolation, and has a format designed to reduce stigma, and increase parental&#xD;
           participation and engagement. It emphasizes individual goal-setting and a&#xD;
           self-reflective learning style, as well as intensive behavior practice and rehearsal&#xD;
           methods with other parents and a positive, collaborative relationship between group&#xD;
           leaders and parents. For the previous reasons it may be particularly relevant to&#xD;
           families with child protection services contact and should be thoroughly researched.&#xD;
&#xD;
        2. Aims&#xD;
&#xD;
           The main study question is:&#xD;
&#xD;
           Does the group based, intensive Incredible Years Parent Management Training reduce&#xD;
           children's (age 3-7) (sub)clinically significant behavioral problems?&#xD;
&#xD;
           The other study questions are:&#xD;
&#xD;
           Does Incredible Years Parent Management Training&#xD;
&#xD;
             -  increase positive parenting?&#xD;
&#xD;
             -  increase positive interaction between parents and children?&#xD;
&#xD;
             -  reduce children's (age 3-7) other psychiatric symptoms?&#xD;
&#xD;
             -  reduce children's and parent's stress?&#xD;
&#xD;
             -  increase parent's well-being?&#xD;
&#xD;
        3. Study Design Randomized controlled trial design will be used (RCT). Participants are 3-7&#xD;
           year old children (index children, n=101) with behavioral problems and their parents who&#xD;
           are currently clients of child protection services, other special support services for&#xD;
           families or families who are clients of family centers or need support just for their&#xD;
           parenting. Parents and children were randomized before the baseline measurements to the&#xD;
           intervention group or treatment as usual / waiting list condition. The intervention&#xD;
           program is Incredible Years Parent Training (Preschool Basic), with 20 parent group&#xD;
           meetings, including 4 home visits. Children themselves do not participate in any&#xD;
           intervention. Based on earlier studies the intervention effects of parent management&#xD;
           training is mediated by changed parenting practices towards children. The measuring&#xD;
           points are pre, post and 1 year. The study will be carried out in 2015-2018.&#xD;
&#xD;
           Intervention Participants will attend the Incredible Years Parent Training Program,&#xD;
           Preschool Basic version, with 18-20 group meetings. The program is based mainly on&#xD;
           cognitive-behavioral and social learning theories.&#xD;
&#xD;
           The goal of the group is to enhance and support parenting skills, increase knowledge of&#xD;
           child development, improve child's positive behavior and parent-child interaction.&#xD;
           Parents are taught to use more positive and consistent strategies in reducing child&#xD;
           misbehavior by watching dvd's, rehearsing and group discussions. Groups consist of 10-12&#xD;
           parents and they get together weekly for app. 2-2,5 hours at a time. Four home visits&#xD;
           are added to the program to support parents in practicing new skills and to provide&#xD;
           individual practical consultation. Also weekly phone calls are being made to the&#xD;
           parents, as part of normal procedure of the program.&#xD;
&#xD;
           Parents will be interviewed before starting the intervention to explain it fully.&#xD;
&#xD;
           The intervention groups will start in fall 2016 or beginning of 2017. In each group&#xD;
           there will be three trained group leaders, of which two are from family counselling&#xD;
           services and one a family worker from child protection services, who also conducts&#xD;
           family visits.&#xD;
&#xD;
           Program fidelity The group leaders will receive supervision from certified peer coach&#xD;
           every three weeks and once from a mentor during the duration of the groups. Group&#xD;
           leaders will fill out check lists and self-evaluations after every group meeting. Also&#xD;
           evaluations from parents after every group meeting will be gathered.&#xD;
&#xD;
        4. Ethics&#xD;
&#xD;
      Parents and children are participating voluntarily in the research. Participants of the&#xD;
      intervention group are given concrete information and training about positive parenting&#xD;
      methods in a supportive and positive peer group by trained leaders. The participants of the&#xD;
      control group can access all the other services and support they are entitled to, other than&#xD;
      the intervention program being researched. The restrain and discomfort caused to participants&#xD;
      can be considered minor.&#xD;
&#xD;
      Families participating the study have been interviewed and their willingness to participate&#xD;
      have been asked beforehand. The group leaders of the intervention will interview the&#xD;
      participants of the intervention group and tell about the intervention. The participants of&#xD;
      the control group have a possibility access the next available parent group in the community.&#xD;
&#xD;
      Parents participating the research have at any time a right to withdraw from the research.&#xD;
      Confidentiality will be taken care of.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomize Controlled Trial with intervention and control groups (TAU)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in ECBI (Eyberg Child Behavior Checklist)</measure>
    <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.</time_frame>
    <description>Change of problem behavior measured by ECBI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CBCL (Child Behaviour Checklist) Externalizing scale</measure>
    <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.</time_frame>
    <description>Change of problem behavior measured by CBCL Externalizing scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long term change in ECBI</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Long term change of problem behavior measured by ECBI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long term change in CBCL Externalizing scale</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Long term change of problem behavior measured by CBCL, Externalizing scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in measure of executive functions (measured by KESKY questionnaire)</measure>
    <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.</time_frame>
    <description>Change of a child's executive functions (including, attention, impulsivity and motor restlessness measured by KESKY questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CBCL total scores</measure>
    <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.</time_frame>
    <description>Change in a child's psychiatric problems measured by CBCL total scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dyadic Parent-Child Interaction measured by Dyadic Parent-Child Interaction Coding System</measure>
    <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.</time_frame>
    <description>Parent-child interaction quality evaluated by coding 10 minutes videos of child-led play and parent-led play</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PPI, Parenting Practices Interview</measure>
    <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.</time_frame>
    <description>Parent's self evaluation of his/her parenting practices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PSI-4-SF, Parenting Stress Inventory, short version</measure>
    <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.</time_frame>
    <description>Parent's self evaluation of his/her parenting related stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Marshmallow test</measure>
    <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.</time_frame>
    <description>Child's patience to resist temptation to eat a marshmallow candy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child's risk taking behavior in a gambling task</measure>
    <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 .</time_frame>
    <description>Child's tendency to take risks in a gambling task to win candies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child's trust to another child</measure>
    <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.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dictator game for children</measure>
    <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.</time_frame>
    <description>Altruism, how much the child is willing to give stickers to another child, who doesn't have any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term change in measure of executive functions (measured by KESKY questionnaire)</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Change of a child's executive functions (including attention, impulsivity and motor restlessness measured by KESKY questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term change in CBCL total scores</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Change in a child's psychiatric problems measured by CBCL total scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term change in Dyadic Parent-Child Interaction measured by Dyadic Parent-Child Interaction Coding System</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Parent-child interaction quality evaluated by coding 10 minutes videos of child-led play and parent-led play</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term change in PPI, Parenting Practices Interview</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Parent's self evaluation of his/her parenting practices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term change in PSI-4-SF, Parenting Stress Inventory, short version</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Parent's self evaluation of his/her parenting related stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term change in the Marshmallow test</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Child's patience to resist temptation to eat a marshmallow candy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term change in child's risk taking behavior in a gambling task</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Child's tendency to take risks in a gambling task to win candies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term change in child's trust to another child</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term change in Dictator game for children</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Altruism, how much the child is willing to give stickers to another child, who doesn't have any.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in GHQ, General Health Questionnaire, for parent</measure>
    <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.</time_frame>
    <description>Parent's general psycho-social health</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in SWEMWBS (Short version of Warwick-Edinburgh Mental Well-being Scale), Positive mental health questionnaire</measure>
    <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.</time_frame>
    <description>Parent's self evaluation of his/her mental well being</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Heart rate during rest</measure>
    <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.</time_frame>
    <description>Both the parent and the child, to evaluate stress, measured during 10 minutes rest</description>
  </other_outcome>
  <other_outcome>
    <measure>Long term change in GHQ, General Health Questionnaire, for parent</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Parent's general psycho-social health</description>
  </other_outcome>
  <other_outcome>
    <measure>Long term change in SWEMWBS, Positive mental health questionnaire</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Parent's self evaluation of his/her mental well being</description>
  </other_outcome>
  <other_outcome>
    <measure>Long term change in Heart rate during rest</measure>
    <time_frame>Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.</time_frame>
    <description>Both the parent and the child, to evaluate stress, measured during 10 minutes rest</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Conduct Disorders in Children</condition>
  <arm_group>
    <arm_group_label>Incredible Years, Parent support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive treatment as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Incredible Years, Parent group supported by home visiting</intervention_name>
    <description>Parents are taught to use positive and consistent strategies in reducing child misbehavior</description>
    <arm_group_label>Incredible Years, Parent support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents of the child are evaluated by child protection services to benefit from&#xD;
             parenting support, or who receive special support for parenting&#xD;
&#xD;
          -  Child is between the ages 3-7 when entering the program&#xD;
&#xD;
          -  The child is living at home&#xD;
&#xD;
          -  Child has behavioral problems&#xD;
&#xD;
          -  Parents have the motivation to attend the groups&#xD;
&#xD;
          -  There is no unresolved acute child protection issue (child's basic needs and safety&#xD;
             are not fulfilled).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents have a mental health or substance abuse problem that prevents attending the&#xD;
             group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Piia Karjalainen, M.ED</last_name>
    <role>Study Director</role>
    <affiliation>Finnish Institute for Health and Welfare</affiliation>
  </overall_official>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>November 29, 2021</last_update_submitted>
  <last_update_submitted_qc>November 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Finnish Institute for Health and Welfare</investigator_affiliation>
    <investigator_full_name>Piia Karjalainen</investigator_full_name>
    <investigator_title>Senior Researcher</investigator_title>
  </responsible_party>
  <keyword>Children's mental health</keyword>
  <keyword>Conduct disorders</keyword>
  <keyword>Conduct problems</keyword>
  <keyword>Externalizing problems</keyword>
  <keyword>Parental Intervention</keyword>
  <keyword>Groups based intervention</keyword>
  <keyword>Finland</keyword>
  <keyword>Social learning theory</keyword>
  <keyword>Cognitive-behavioral theory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conduct Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03239990
org study id: THL/1059/6.02.01/2015
nct id: NCT03239990
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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?

        3. 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.

        4. 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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomize Controlled Trial with intervention and control groups (TAU)
primary purpose: Prevention
masking: None (Open Label)
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.
description: Change of problem behavior measured by ECBI
measure: Change in CBCL (Child Behaviour Checklist) Externalizing scale
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.
description: Change of problem behavior measured by CBCL Externalizing scale
measure: Long term change in ECBI
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Long term change of problem behavior measured by ECBI
measure: Long term change in CBCL Externalizing scale
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Long term change of problem behavior measured by CBCL, Externalizing scale
measure: Change in measure of executive functions (measured by KESKY questionnaire)
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.
description: Change of a child's executive functions (including, attention, impulsivity and motor restlessness measured by KESKY questionnaire)
measure: Change in CBCL total scores
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.
description: Change in a child's psychiatric problems measured by CBCL total scores
measure: Change in Dyadic Parent-Child Interaction measured by Dyadic Parent-Child Interaction Coding System
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.
description: Parent-child interaction quality evaluated by coding 10 minutes videos of child-led play and parent-led play
measure: Change in PPI, Parenting Practices Interview
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.
description: Parent's self evaluation of his/her parenting practices
measure: Change in PSI-4-SF, Parenting Stress Inventory, short version
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.
description: Parent's self evaluation of his/her parenting related stress
measure: Change in the Marshmallow test
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.
description: Child's patience to resist temptation to eat a marshmallow candy
measure: Change in child's risk taking behavior in a gambling task
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 .
description: Child's tendency to take risks in a gambling task to win candies
measure: Change in child's trust to another child
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.
description: 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.
measure: Change in Dictator game for children
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.
description: Altruism, how much the child is willing to give stickers to another child, who doesn't have any.
measure: Long term change in measure of executive functions (measured by KESKY questionnaire)
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Change of a child's executive functions (including attention, impulsivity and motor restlessness measured by KESKY questionnaire)
measure: Long term change in CBCL total scores
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Change in a child's psychiatric problems measured by CBCL total scores
measure: Long term change in Dyadic Parent-Child Interaction measured by Dyadic Parent-Child Interaction Coding System
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Parent-child interaction quality evaluated by coding 10 minutes videos of child-led play and parent-led play
measure: Long term change in PPI, Parenting Practices Interview
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Parent's self evaluation of his/her parenting practices
measure: Long term change in PSI-4-SF, Parenting Stress Inventory, short version
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Parent's self evaluation of his/her parenting related stress
measure: Long term change in the Marshmallow test
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Child's patience to resist temptation to eat a marshmallow candy
measure: Long term change in child's risk taking behavior in a gambling task
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Child's tendency to take risks in a gambling task to win candies
measure: Long term change in child's trust to another child
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: 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.
measure: Long term change in Dictator game for children
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Altruism, how much the child is willing to give stickers to another child, who doesn't have any.
measure: Change in GHQ, General Health Questionnaire, for parent
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.
description: Parent's general psycho-social health
measure: Change in SWEMWBS (Short version of Warwick-Edinburgh Mental Well-being Scale), Positive mental health questionnaire
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.
description: Parent's self evaluation of his/her mental well being
measure: Change in Heart rate during rest
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.
description: Both the parent and the child, to evaluate stress, measured during 10 minutes rest
measure: Long term change in GHQ, General Health Questionnaire, for parent
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Parent's general psycho-social health
measure: Long term change in SWEMWBS, Positive mental health questionnaire
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Parent's self evaluation of his/her mental well being
measure: Long term change in Heart rate during rest
time frame: Baseline measure is conducted 0-4 months before starting the intervention and postintervention measure is measured 12-15 months after the intervention is finished.
description: Both the parent and the child, to evaluate stress, measured during 10 minutes rest
arm group label: Incredible Years, Parent support
arm group type: Experimental
description: 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.
arm group label: Treatment as usual
arm group type: No Intervention
description: The control group will receive treatment as usual
intervention type: Behavioral
intervention name: Incredible Years, Parent group supported by home visiting
description: Parents are taught to use positive and consistent strategies in reducing child misbehavior
arm group label: Incredible Years, Parent support
criteria: 
gender: All
minimum age: 3 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Piia Karjalainen, M.ED
role: Study Director
affiliation: Finnish Institute for Health and Welfare
responsible party type: Principal Investigator
investigator affiliation: Finnish Institute for Health and Welfare
investigator full name: Piia Karjalainen
investigator title: Senior Researcher
mesh term: Conduct Disorder
sharing ipd: No