<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/NCT01684644</url>
  </required_header>
  <id_info>
    <org_study_id>7-10-1294</org_study_id>
    <secondary_id>7-10-1294</secondary_id>
    <nct_id>NCT01684644</nct_id>
  </id_info>
  <brief_title>A Controlled Study of Parent Training in the Treatment of ADHD in Young Children</brief_title>
  <acronym>D'SNAPP</acronym>
  <official_title>Parent Training for Preschool ADHD: A Randomised Controlled, Multicentre Effectiveness Trial of the New Forest Parenting Programme in a Clinical Sample of Danish Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glostrup University Hospital, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>TrygFonden, Denmark</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sygekassernes Helsefond</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effectiveness of parent training in the&#xD;
      treatment of ADHD in young children (ages 3-7) referred to Danish child mental health&#xD;
      services. Medication is not recommended as first-line treatment for young children with ADHD.&#xD;
      Parent training is recommended, but has not been formally introduced or established in&#xD;
      Denmark. The study will investigate the effectiveness of a parent training programme&#xD;
      specifically developed to target ADHD symptoms in young children; The New Forest Parenting&#xD;
      Programme, against Treatment as Usual for children diagnosed with ADHD at two different child&#xD;
      mental health clinics in Denmark.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Description: A study to: 1) Address the need for non-pharmacological treatment in young&#xD;
      children with ADHD and 2) Address the need for the development of evidence-based psychosocial&#xD;
      treatment interventions in Danish child mental health services, through the implementation of&#xD;
      the New Forest Parenting Programme (NFPP).&#xD;
&#xD;
      Rationale: ADHD is a neuro-developmental disorder with symptoms frequently occurring in early&#xD;
      childhood. ADHD is associated with long-term personal, psychosocial sequalae. ADHD presents a&#xD;
      considerable societal cost burden, both for mental health services, but also in areas such as&#xD;
      education, employment, the criminal justice system. Pharmacological treatment of preschool&#xD;
      ADHD is not recommended as first-line treatment, due to a number of reasons, including lack&#xD;
      of evidence for efficacy, parental concerns, side effects on growth rates, and the unknown&#xD;
      long-term implications for the developing brain. Effective psychosocial treatments for ADHD&#xD;
      are therefore of central public priority generally, and for child mental health services,&#xD;
      specifically. Currently, psychosocial interventions for ADHD in pre-school children in Danish&#xD;
      Child and Adolescent Mental Health Services (CAMHS) are not well described or systematically&#xD;
      developed. There is a pressing need to develop evidence-based psycho-social treatments for&#xD;
      young children with ADHD in Danish CAMHS.&#xD;
&#xD;
      Design: The study will be a randomised controlled multi-centre effectiveness trial comparing&#xD;
      NFPP intervention to a Treatment as Usual control group. The trial will recruit 200 preschool&#xD;
      children (aged 3-6) with a diagnosis of ADHD from two Danish outpatient child mental health&#xD;
      service sites. Participants will be randomised to either 1) NFPP over a period of 8 weeks or&#xD;
      2) a control group receiving Treatment as Usual (TAU). Outcome: The primary outcome measure&#xD;
      will be child ADHD symptoms. Secondary outcomes include parental wellbeing, child quality of&#xD;
      life, parent-child interactions. Measures will be collected at three time points to track&#xD;
      changes in outcome: T1: Before start of intervention or TAU condition. T2: Directly after the&#xD;
      intervention or TAU and T3: 6 month follow-up after T1 for both arms of the trial. The study&#xD;
      will perform exploratory moderator and mediator analyses.&#xD;
&#xD;
      Expertise: The study receives external consultation from an international expert team for the&#xD;
      planning, execution, NFPP training and supervision. The team consists of research and&#xD;
      clinical experts in the treatment and evaluation of interventions for preschool ADHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ADHD Rating Scale IV-Preschool Version</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>A screening instrument for the symptoms of AD/HD in the preschool population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preschool ADHD-RS (Teacher completed) 18 items</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>screening instrument for the symptoms of AD/HD in the preschool population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength and Difficulties Questionnaire (parent version)</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>A brief measure of prosocial behaviour and and psychopathology of 3-16 year olds that can be completed by parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength and Difficulties Questionnaire (teacher completed)</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>A brief measure of prosocial behaviour and and psychopathology of 3-16 year olds that can be completed by teachers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child solo play - observation measure -</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>Observation measure: Index of Attention scale assessed from 'time on task'/no. of switches in activity' with high scores representing more attention and less switching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Health Questionnaire (CHQ-28)</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>Quality of life measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Strain Index 6 items</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>Short screening instrument for the detection of family strain</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Parental report on somatic complaints in preschool children</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>Parental report on somatic complaints in preschool children (Domenech-Llaberia et al., 2004)</description>
  </other_outcome>
  <other_outcome>
    <measure>6. The Adult ADHD self-report scale (ASRS-V1.1) 18 items The Adult ADHD self-report scale (ASRS-V1.1) 18 items</measure>
    <time_frame>T1 (Baseline)</time_frame>
    <description>Adult ADHD screening instrument</description>
  </other_outcome>
  <other_outcome>
    <measure>Parent sense of competence scale (PSOC) (17 items)</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>Instrument to assess perceived sense of parenting competence</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal expressed emotion - 5 min speech sample.</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>A 5-min speech sample obtained from mothers, rated over 6 scales with an overall high score indicating a negative influence on the child.</description>
  </other_outcome>
  <other_outcome>
    <measure>GIPCI (Jigsaw/Tidy up/Freeplay) observation measure</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>GIPCI (Jigsaw/Tidy up/Freeplay) observation measure of parent child interaction with global ratings (0-5) for parent and child behaviours</description>
  </other_outcome>
  <other_outcome>
    <measure>General Health Questionnaire (12 item)</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
    <description>Screening instrument to detect psychiatric disorders in adults</description>
  </other_outcome>
  <other_outcome>
    <measure>Neuropsychological test battery</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1)</time_frame>
    <description>Working memory (verbal and visuospatial) measured by Word span Forward and Backward as well as using Finger Windows Forward and Backward.&#xD;
Inhibition measured using a modified four picture pairs Stroop Task as well as the Head-Toes-Knees-Shoulders task.&#xD;
Flexibility measured using the Switching, Inhibition, and Flexibility Task as well as the Trails-P.&#xD;
Delay-related behavior measured with the Cookie Delay Task and the Teddy Delay Task&#xD;
Simple information processing time measured using the Fish task.&#xD;
In addition, video recordings of the neuropsychological evaluation will be coded and analyzed (private speech and behavior) after the test session</description>
  </other_outcome>
  <other_outcome>
    <measure>Behavior Rating Inventory of Executive Function - Preschool Version [BRIEF-P]</measure>
    <time_frame>T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>New Forest Parenting Programme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The New Forest Parenting Programme is a parent training programme specifically developed to treat ADHD in preschool children. The programme is delivered as an 8 week intervention for individual parents and their child.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment as usual for preschool ADHD consists of psychoeducation groups for parents.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>New Forest Parenting Programme</intervention_name>
    <arm_group_label>New Forest Parenting Programme</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <other_name>Psychoeducation in groups for parents of young children diagnosed with ADHD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A clinical diagnosis of ADHD, as measured by the DAWBA&#xD;
&#xD;
          2. Participants first language must be Danish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children with intellectual disabilities (i.e. IQ &lt; 70), Autism Spectrum Disorders.&#xD;
&#xD;
          2. Severe parental psychiatric disorder&#xD;
&#xD;
          3. Severe social adversity, as defined by social services involvement due to suspicions&#xD;
             of or detected neglect.&#xD;
&#xD;
          4. Child receiving medication or other treatment for ADHD symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Per Hove Thomsen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Børne- og Ungdomspsykiatrisk Center-Risskov, Aarhus Universitetshospital, Skovagervej 2, 8240 Risskov, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for child and adolescent psychiatry</name>
      <address>
        <city>Risskov,</city>
        <state>Aarhus</state>
        <zip>8240</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>June 29, 2017</last_update_submitted>
  <last_update_submitted_qc>June 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>Parent Training</keyword>
  <keyword>RCT</keyword>
  <keyword>Preschool</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <!-- 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/NCT01684644
org study id: 7-10-1294
secondary id: 7-10-1294
nct id: NCT01684644
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the effectiveness of parent training in the
      treatment of ADHD in young children (ages 3-7) referred to Danish child mental health
      services. Medication is not recommended as first-line treatment for young children with ADHD.
      Parent training is recommended, but has not been formally introduced or established in
      Denmark. The study will investigate the effectiveness of a parent training programme
      specifically developed to target ADHD symptoms in young children; The New Forest Parenting
      Programme, against Treatment as Usual for children diagnosed with ADHD at two different child
      mental health clinics in Denmark.
Description: A study to: 1) Address the need for non-pharmacological treatment in young
      children with ADHD and 2) Address the need for the development of evidence-based psychosocial
      treatment interventions in Danish child mental health services, through the implementation of
      the New Forest Parenting Programme (NFPP).

      Rationale: ADHD is a neuro-developmental disorder with symptoms frequently occurring in early
      childhood. ADHD is associated with long-term personal, psychosocial sequalae. ADHD presents a
      considerable societal cost burden, both for mental health services, but also in areas such as
      education, employment, the criminal justice system. Pharmacological treatment of preschool
      ADHD is not recommended as first-line treatment, due to a number of reasons, including lack
      of evidence for efficacy, parental concerns, side effects on growth rates, and the unknown
      long-term implications for the developing brain. Effective psychosocial treatments for ADHD
      are therefore of central public priority generally, and for child mental health services,
      specifically. Currently, psychosocial interventions for ADHD in pre-school children in Danish
      Child and Adolescent Mental Health Services (CAMHS) are not well described or systematically
      developed. There is a pressing need to develop evidence-based psycho-social treatments for
      young children with ADHD in Danish CAMHS.

      Design: The study will be a randomised controlled multi-centre effectiveness trial comparing
      NFPP intervention to a Treatment as Usual control group. The trial will recruit 200 preschool
      children (aged 3-6) with a diagnosis of ADHD from two Danish outpatient child mental health
      service sites. Participants will be randomised to either 1) NFPP over a period of 8 weeks or
      2) a control group receiving Treatment as Usual (TAU). Outcome: The primary outcome measure
      will be child ADHD symptoms. Secondary outcomes include parental wellbeing, child quality of
      life, parent-child interactions. Measures will be collected at three time points to track
      changes in outcome: T1: Before start of intervention or TAU condition. T2: Directly after the
      intervention or TAU and T3: 6 month follow-up after T1 for both arms of the trial. The study
      will perform exploratory moderator and mediator analyses.

      Expertise: The study receives external consultation from an international expert team for the
      planning, execution, NFPP training and supervision. The team consists of research and
      clinical experts in the treatment and evaluation of interventions for preschool ADHD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: ADHD Rating Scale IV-Preschool Version
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: A screening instrument for the symptoms of AD/HD in the preschool population.
measure: Preschool ADHD-RS (Teacher completed) 18 items
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: screening instrument for the symptoms of AD/HD in the preschool population.
measure: Strength and Difficulties Questionnaire (parent version)
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: A brief measure of prosocial behaviour and and psychopathology of 3-16 year olds that can be completed by parents
measure: Strength and Difficulties Questionnaire (teacher completed)
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: A brief measure of prosocial behaviour and and psychopathology of 3-16 year olds that can be completed by teachers
measure: Child solo play - observation measure -
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: Observation measure: Index of Attention scale assessed from 'time on task'/no. of switches in activity' with high scores representing more attention and less switching
measure: Child Health Questionnaire (CHQ-28)
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: Quality of life measure
measure: Family Strain Index 6 items
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: Short screening instrument for the detection of family strain
measure: Parental report on somatic complaints in preschool children
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: Parental report on somatic complaints in preschool children (Domenech-Llaberia et al., 2004)
measure: 6. The Adult ADHD self-report scale (ASRS-V1.1) 18 items The Adult ADHD self-report scale (ASRS-V1.1) 18 items
time frame: T1 (Baseline)
description: Adult ADHD screening instrument
measure: Parent sense of competence scale (PSOC) (17 items)
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: Instrument to assess perceived sense of parenting competence
measure: Maternal expressed emotion - 5 min speech sample.
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: A 5-min speech sample obtained from mothers, rated over 6 scales with an overall high score indicating a negative influence on the child.
measure: GIPCI (Jigsaw/Tidy up/Freeplay) observation measure
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: GIPCI (Jigsaw/Tidy up/Freeplay) observation measure of parent child interaction with global ratings (0-5) for parent and child behaviours
measure: General Health Questionnaire (12 item)
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
description: Screening instrument to detect psychiatric disorders in adults
measure: Neuropsychological test battery
time frame: T1 (at baseline), T2 (twelve weeks from T1)
description: Working memory (verbal and visuospatial) measured by Word span Forward and Backward as well as using Finger Windows Forward and Backward.
Inhibition measured using a modified four picture pairs Stroop Task as well as the Head-Toes-Knees-Shoulders task.
Flexibility measured using the Switching, Inhibition, and Flexibility Task as well as the Trails-P.
Delay-related behavior measured with the Cookie Delay Task and the Teddy Delay Task
Simple information processing time measured using the Fish task.
In addition, video recordings of the neuropsychological evaluation will be coded and analyzed (private speech and behavior) after the test session
measure: Behavior Rating Inventory of Executive Function - Preschool Version [BRIEF-P]
time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
arm group label: New Forest Parenting Programme
arm group type: Experimental
description: The New Forest Parenting Programme is a parent training programme specifically developed to treat ADHD in preschool children. The programme is delivered as an 8 week intervention for individual parents and their child.
arm group label: Treatment as Usual
arm group type: Other
description: Treatment as usual for preschool ADHD consists of psychoeducation groups for parents.
intervention type: Behavioral
intervention name: New Forest Parenting Programme
arm group label: New Forest Parenting Programme
intervention type: Behavioral
intervention name: Treatment as usual
arm group label: Treatment as Usual
other name: Psychoeducation in groups for parents of young children diagnosed with ADHD
criteria: 
gender: All
minimum age: 3 Years
maximum age: 7 Years
healthy volunteers: No
last name: Per Hove Thomsen, MD
role: Study Chair
affiliation: Børne- og Ungdomspsykiatrisk Center-Risskov, Aarhus Universitetshospital, Skovagervej 2, 8240 Risskov, Denmark
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Attention Deficit Disorder with Hyperactivity