<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/NCT03832270</url>
  </required_header>
  <id_info>
    <org_study_id>HIPS/17/58</org_study_id>
    <nct_id>NCT03832270</nct_id>
  </id_info>
  <brief_title>Support for PARents of Children Living With ADHD - a Research Trial</brief_title>
  <acronym>SPARCLAR</acronym>
  <official_title>SPARCLAR: A Feasibility Randomised Controlled Trial of a Parenting Support Programme Focussed on Families Affected by ADHD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Fife</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chief Scientist Office of the Scottish Government</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Glasgow</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic and pervasive disorder&#xD;
      characterised by problems in attention, impulse control and activity regulation that&#xD;
      substantially burdens patients, families, and society. The efficacy of behavioural training&#xD;
      for parents of children with ADHD symptoms is well established, however it is less clear&#xD;
      which type of parenting intervention should be offered, and which aspects of parenting&#xD;
      behaviour to focus on. It is not established whether an intervention designed specifically&#xD;
      for families of children with a diagnosis will be more effective and cost effective than less&#xD;
      specifically-targeted interventions. The purpose of this study is to determine the&#xD;
      feasibility and likely size of a substantive randomised controlled trial comparing an AHDH&#xD;
      specific parenting intervention to a diagnostically less-specific parenting intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic and pervasive disorder&#xD;
      characterised by problems in attention, impulse control and activity regulation that&#xD;
      substantially burdens patients, families, and society. ADHD is often associated with&#xD;
      challenging behaviours that can induce negativity, even in parents who would otherwise cope&#xD;
      well.The efficacy of behavioural training for parents of children with ADHD symptoms is well&#xD;
      established, however it is less clear which type of parenting intervention should be offered,&#xD;
      and which aspects of parenting behaviour to focus on. It is not established whether an&#xD;
      intervention designed specifically for families of children with a diagnosis will be more&#xD;
      effective and cost effective than less specifically-targeted interventions.&#xD;
&#xD;
      Parents In Control (Parents InC) offers specific support around empowerment, information and&#xD;
      behaviour management specific to ADHD, as well as understanding of the child's development&#xD;
      context. Parents InC has been used for a number of years in Scotland and has been evaluated,&#xD;
      with promising results, but with relatively small sample sizes, no long-term follow-up, no&#xD;
      economic evaluation and, most crucially, no comparison to an alternative intervention or to a&#xD;
      control group. The investigators now need to understand if it: i) is at least as effective as&#xD;
      the current best-evidenced alternative, Incredible Years, in impacting children's behaviour&#xD;
      outcomes; ii) is cost-effective; and iii) offers something helpful and unique compared to&#xD;
      other parenting programmes in terms of parenting self-competence and quality of life.&#xD;
&#xD;
      The purpose of this study is to determine the feasibility and likely size of a substantive&#xD;
      randomised controlled trial comparing an ADHD specific parenting intervention to a&#xD;
      diagnostically less-specific parenting intervention (Incredible Years). Specific objectives&#xD;
      are to test (1) whether parents of children recently diagnosed with ADHD are willing to be&#xD;
      randomised to Parents InC or IY; (2) whether sufficient numbers of families can be (a)&#xD;
      recruited and (b) retained such that a full-scale RCT is likely to be feasible; (3) whether&#xD;
      research procedures and efficacy measures are feasible and acceptable to participating&#xD;
      families (including health economic measures and consent to link to routine datasets); (4)&#xD;
      whether families participating in Parents InC achieve similar scores on the parenting sense&#xD;
      of competence scale at 12 months post randomisation as those in the comparison arm&#xD;
      (Incredible Years); (5) Whether the two intervention arms significantly differ on any other&#xD;
      measures; and (6) the mean cost per participant of Parents InC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Parallel pilot RCT (MRC feasibility phase)</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants and assessors will be blind to treatment allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of parents willing to be randomised to Parents InC or Incredible Years.</measure>
    <time_frame>Continuous over 1 year study period</time_frame>
    <description>Measured by number of parents agreed to randomisation throughout the study period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of parents recruited and retained.</measure>
    <time_frame>Continuous over 1 year study period</time_frame>
    <description>Measured by number of parents recruited and retained throughout the study period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Research procedures feasibility and acceptability</measure>
    <time_frame>Continuous over 1 year study period</time_frame>
    <description>Face to face interviews will be conducted with participating families to assess the feasibility and acceptability of research procedures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary efficacy outcome: Parental Sense of Competence Scale.</measure>
    <time_frame>Baseline, 12-months post-randomisation</time_frame>
    <description>17-items measure of parenting self-esteem questionnaire with 2 sub scales. Each item is rated on a 6 point Likert scale anchored by 1= &quot;Strongly Disagree&quot; and 6= &quot;Strongly Agree&quot;. A higher score indicates a higher parenting sense of competency. There are no average scores or 'cut-off's' for this tool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eyberg Child Behaviour Inventory.</measure>
    <time_frame>Baseline, 12-month post-randomisation</time_frame>
    <description>36-items measure (parent reported) that assesses the current frequency and severity of child's behaviour. Items are rated on a 7-point intensity scale and a yes/no Problem scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Health Questionnaire.</measure>
    <time_frame>Baseline, 12-month post-randomisation</time_frame>
    <description>12-items self-report measure of common psychiatric conditions of parents. Each item is accompanied with four responses; &quot;Not at all&quot;, &quot;No more than usual&quot;, &quot;Rather more than usual&quot; and &quot;Much more than usual&quot;. Items are rated on a 4-point response scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADHD Symptom Rating Scale-Version 1.</measure>
    <time_frame>Baseline, 12-month post-randomisation</time_frame>
    <description>Self-report symptom checklist consisting of 18 DSM-IV criteria for parents. The checklist assesses occurrence frequency of each symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Daily Hassles Scale.</measure>
    <time_frame>Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation</time_frame>
    <description>18-items self-report measure of the frequency and intensity of 20 potential parenting 'hassles' to indicate parents stress. The items are rated on a frequency and intensity scale. The frequency scale is scored rarely =1, sometimes= 2, a lot= 3, and constantly = 4. The intensity scale is scored by adding the parents rating of 1-5 for each item. If a 0 has been scored for frequency on an item then it should be scored 0 for intensity. The range for this scale is 0 -100. This measure will be re-collected if there is &gt; 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goal Based Outcomes.</measure>
    <time_frame>Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation</time_frame>
    <description>Taken from the Child Outcomes Research Consortium to identify goals and assess progression. Progress toward individual goal is rated on a scale from 0 (no progress) to 10 (goal has been reached). This measure will be re-collected if there is &gt; 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation</time_frame>
    <description>Self-report measure of parent quality of life. The EQ-5D-5L is a descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, some problems, moderate problems, extreme problems. Parents will be also be asked to rate their health on a visual analogue scale. This measure will be re-collected if there is &gt; 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paediatric Quality of Life Inventory (PedsQL)</measure>
    <time_frame>Baseline, 12-month post-randomisation</time_frame>
    <description>23-items questionnaire which covers 4 core dimensions (physical, social, emotional and school functioning). Each dimension has 4 levels: never = 0, almost never= 1, sometimes= 2, often= 3 and almost always= 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strengths and Difficulties Questionnaire (SDQ)</measure>
    <time_frame>Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation</time_frame>
    <description>25-items questionnaire which assesses child's emotional and behavioural problems. Each item is scored 0, 1 or 2. Somewhat true is always scored 1, but whether Not true and Certainly true are scored 0 or 2 depends on whether the item is framed as a strength or difficulty. This measure will be re-collected if there is &gt; 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant service use</measure>
    <time_frame>12-month post-randomisation</time_frame>
    <description>Measured using diaries</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Attention Deficit Disorder With Hyperactivity</condition>
  <arm_group>
    <arm_group_label>Parents InC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group parenting support intervention based around four pillars: 1) empowerment/ownership; 2) education on ADHD and its effect on family identity/ values; 3) positive parenting in the context of ADHD; 4) making sense of ADHD in a developmental context. It is delivered over 5 weekly 2-hour sessions, a 6 week break, and a follow-up session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Incredible Years</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group parenting support intervention aimed at strengthening parent-child interactions and attachment, reducing harsh discipline and fostering parents' ability to promote children's social, emotional, and academic development. The IY programme is delivered over 14 weekly 2-hour sessions. IY facilitators are videotaped during sessions to maintain intervention fidelity. IY also includes 1-4 pre-intervention preparation sessions which may involve home visits and telephone support and reminders.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parents InC</intervention_name>
    <description>Based on social learning theory, Parents InC has been designed specifically for parents of children with an ADHD diagnosis with a particular focus on parenting sense of self competence.</description>
    <arm_group_label>Parents InC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Incredible Years</intervention_name>
    <description>Also based on social learning theory but focus is not specifically on ADHD.</description>
    <arm_group_label>Incredible Years</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Parents of children aged 5-12 with a formal diagnosis of ADHD, following a standardised&#xD;
        assessment from a paediatrician or a psychiatrist, referred to the Fife integrated ADHD&#xD;
        pathway during the one year recruitment period will be eligible for inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Families attending other parenting groups&#xD;
&#xD;
          -  Parents who have low proficiency in English (as this will compromise their ability to&#xD;
             complete research measures or participate in a group intervention).&#xD;
&#xD;
          -  Participants already taking part in research on a parenting intervention will also be&#xD;
             ineligible to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lucy Thompson</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Helen Minnis</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fiona Sim</last_name>
    <phone>01413308254</phone>
    <email>sparclar@glasgow.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fatene Abakar Ismail</last_name>
    <phone>01413308254</phone>
    <email>sparclar@glasgow.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NHS Fife Psychology Department</name>
      <address>
        <city>Dunfermline</city>
        <state>Scotland</state>
        <zip>KY11 4UW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hilary Maddox, Dr</last_name>
      <phone>01383565400</phone>
      <email>hilarymaddox@nhs.net</email>
    </contact>
    <contact_backup>
      <last_name>Caroline Hollinsworth</last_name>
      <phone>01383 565400</phone>
      <email>carolinehollinsworth@nhs.net</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Glasgow</investigator_affiliation>
    <investigator_full_name>Lucy Thompson</investigator_full_name>
    <investigator_title>International Research Coordinator &amp; Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Parenting support</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The PIs will manage access rights to the data set. We anticipate that anonymised trial data may be shared with other researchers to enable international prospective meta-analyses.</ipd_description>
  </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/NCT03832270
org study id: HIPS/17/58
nct id: NCT03832270
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic and pervasive disorder
      characterised by problems in attention, impulse control and activity regulation that
      substantially burdens patients, families, and society. The efficacy of behavioural training
      for parents of children with ADHD symptoms is well established, however it is less clear
      which type of parenting intervention should be offered, and which aspects of parenting
      behaviour to focus on. It is not established whether an intervention designed specifically
      for families of children with a diagnosis will be more effective and cost effective than less
      specifically-targeted interventions. The purpose of this study is to determine the
      feasibility and likely size of a substantive randomised controlled trial comparing an AHDH
      specific parenting intervention to a diagnostically less-specific parenting intervention.
Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic and pervasive disorder
      characterised by problems in attention, impulse control and activity regulation that
      substantially burdens patients, families, and society. ADHD is often associated with
      challenging behaviours that can induce negativity, even in parents who would otherwise cope
      well.The efficacy of behavioural training for parents of children with ADHD symptoms is well
      established, however it is less clear which type of parenting intervention should be offered,
      and which aspects of parenting behaviour to focus on. It is not established whether an
      intervention designed specifically for families of children with a diagnosis will be more
      effective and cost effective than less specifically-targeted interventions.

      Parents In Control (Parents InC) offers specific support around empowerment, information and
      behaviour management specific to ADHD, as well as understanding of the child's development
      context. Parents InC has been used for a number of years in Scotland and has been evaluated,
      with promising results, but with relatively small sample sizes, no long-term follow-up, no
      economic evaluation and, most crucially, no comparison to an alternative intervention or to a
      control group. The investigators now need to understand if it: i) is at least as effective as
      the current best-evidenced alternative, Incredible Years, in impacting children's behaviour
      outcomes; ii) is cost-effective; and iii) offers something helpful and unique compared to
      other parenting programmes in terms of parenting self-competence and quality of life.

      The purpose of this study is to determine the feasibility and likely size of a substantive
      randomised controlled trial comparing an ADHD specific parenting intervention to a
      diagnostically less-specific parenting intervention (Incredible Years). Specific objectives
      are to test (1) whether parents of children recently diagnosed with ADHD are willing to be
      randomised to Parents InC or IY; (2) whether sufficient numbers of families can be (a)
      recruited and (b) retained such that a full-scale RCT is likely to be feasible; (3) whether
      research procedures and efficacy measures are feasible and acceptable to participating
      families (including health economic measures and consent to link to routine datasets); (4)
      whether families participating in Parents InC achieve similar scores on the parenting sense
      of competence scale at 12 months post randomisation as those in the comparison arm
      (Incredible Years); (5) Whether the two intervention arms significantly differ on any other
      measures; and (6) the mean cost per participant of Parents InC.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel pilot RCT (MRC feasibility phase)
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: Participants and assessors will be blind to treatment allocation.
measure: Number of parents willing to be randomised to Parents InC or Incredible Years.
time frame: Continuous over 1 year study period
description: Measured by number of parents agreed to randomisation throughout the study period.
measure: Number of parents recruited and retained.
time frame: Continuous over 1 year study period
description: Measured by number of parents recruited and retained throughout the study period.
measure: Research procedures feasibility and acceptability
time frame: Continuous over 1 year study period
description: Face to face interviews will be conducted with participating families to assess the feasibility and acceptability of research procedures.
measure: Primary efficacy outcome: Parental Sense of Competence Scale.
time frame: Baseline, 12-months post-randomisation
description: 17-items measure of parenting self-esteem questionnaire with 2 sub scales. Each item is rated on a 6 point Likert scale anchored by 1= "Strongly Disagree" and 6= "Strongly Agree". A higher score indicates a higher parenting sense of competency. There are no average scores or 'cut-off's' for this tool.
measure: Eyberg Child Behaviour Inventory.
time frame: Baseline, 12-month post-randomisation
description: 36-items measure (parent reported) that assesses the current frequency and severity of child's behaviour. Items are rated on a 7-point intensity scale and a yes/no Problem scale.
measure: General Health Questionnaire.
time frame: Baseline, 12-month post-randomisation
description: 12-items self-report measure of common psychiatric conditions of parents. Each item is accompanied with four responses; "Not at all", "No more than usual", "Rather more than usual" and "Much more than usual". Items are rated on a 4-point response scale.
measure: ADHD Symptom Rating Scale-Version 1.
time frame: Baseline, 12-month post-randomisation
description: Self-report symptom checklist consisting of 18 DSM-IV criteria for parents. The checklist assesses occurrence frequency of each symptom.
measure: Parenting Daily Hassles Scale.
time frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
description: 18-items self-report measure of the frequency and intensity of 20 potential parenting 'hassles' to indicate parents stress. The items are rated on a frequency and intensity scale. The frequency scale is scored rarely =1, sometimes= 2, a lot= 3, and constantly = 4. The intensity scale is scored by adding the parents rating of 1-5 for each item. If a 0 has been scored for frequency on an item then it should be scored 0 for intensity. The range for this scale is 0 -100. This measure will be re-collected if there is > 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.
measure: Goal Based Outcomes.
time frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
description: Taken from the Child Outcomes Research Consortium to identify goals and assess progression. Progress toward individual goal is rated on a scale from 0 (no progress) to 10 (goal has been reached). This measure will be re-collected if there is > 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.
measure: EQ-5D-5L
time frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
description: Self-report measure of parent quality of life. The EQ-5D-5L is a descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, some problems, moderate problems, extreme problems. Parents will be also be asked to rate their health on a visual analogue scale. This measure will be re-collected if there is > 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.
measure: Paediatric Quality of Life Inventory (PedsQL)
time frame: Baseline, 12-month post-randomisation
description: 23-items questionnaire which covers 4 core dimensions (physical, social, emotional and school functioning). Each dimension has 4 levels: never = 0, almost never= 1, sometimes= 2, often= 3 and almost always= 4.
measure: Strengths and Difficulties Questionnaire (SDQ)
time frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
description: 25-items questionnaire which assesses child's emotional and behavioural problems. Each item is scored 0, 1 or 2. Somewhat true is always scored 1, but whether Not true and Certainly true are scored 0 or 2 depends on whether the item is framed as a strength or difficulty. This measure will be re-collected if there is > 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.
measure: Participant service use
time frame: 12-month post-randomisation
description: Measured using diaries
arm group label: Parents InC
arm group type: Experimental
description: Group parenting support intervention based around four pillars: 1) empowerment/ownership; 2) education on ADHD and its effect on family identity/ values; 3) positive parenting in the context of ADHD; 4) making sense of ADHD in a developmental context. It is delivered over 5 weekly 2-hour sessions, a 6 week break, and a follow-up session.
arm group label: Incredible Years
arm group type: Active Comparator
description: A group parenting support intervention aimed at strengthening parent-child interactions and attachment, reducing harsh discipline and fostering parents' ability to promote children's social, emotional, and academic development. The IY programme is delivered over 14 weekly 2-hour sessions. IY facilitators are videotaped during sessions to maintain intervention fidelity. IY also includes 1-4 pre-intervention preparation sessions which may involve home visits and telephone support and reminders.
intervention type: Behavioral
intervention name: Parents InC
description: Based on social learning theory, Parents InC has been designed specifically for parents of children with an ADHD diagnosis with a particular focus on parenting sense of self competence.
arm group label: Parents InC
intervention type: Behavioral
intervention name: Incredible Years
description: Also based on social learning theory but focus is not specifically on ADHD.
arm group label: Incredible Years
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
healthy volunteers: No
last name: Lucy Thompson
role: Principal Investigator
affiliation: University of Glasgow
last name: Helen Minnis
role: Principal Investigator
affiliation: University of Glasgow
last name: Fiona Sim
phone: 01413308254
email: sparclar@glasgow.ac.uk
last name: Fatene Abakar Ismail
phone: 01413308254
email: sparclar@glasgow.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Glasgow
investigator full name: Lucy Thompson
investigator title: International Research Coordinator & Research Fellow
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: Undecided
ipd description: The PIs will manage access rights to the data set. We anticipate that anonymised trial data may be shared with other researchers to enable international prospective meta-analyses.