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Support for PARents of Children Living With ADHD - a Research Trial (SPARCLAR)

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ClinicalTrials.gov Identifier: NCT03832270
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
NHS Fife
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
Lucy Thompson, University of Glasgow

Tracking Information
First Submitted Date  ICMJE December 4, 2018
First Posted Date  ICMJE February 6, 2019
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE January 21, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Number of parents willing to be randomised to Parents InC or Incredible Years. [ Time Frame: Continuous over 1 year study period ]
    Measured by number of parents agreed to randomisation throughout the study period.
  • Number of parents recruited and retained. [ Time Frame: Continuous over 1 year study period ]
    Measured by number of parents recruited and retained throughout the study period.
  • Research procedures feasibility and acceptability [ Time Frame: Continuous over 1 year study period ]
    Face to face interviews will be conducted with participating families to assess the feasibility and acceptability of research procedures.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03832270 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • Primary efficacy outcome: Parental Sense of Competence Scale. [ Time Frame: Baseline, 12-months post-randomisation ]
    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.
  • Eyberg Child Behaviour Inventory. [ Time Frame: Baseline, 12-month post-randomisation ]
    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.
  • General Health Questionnaire. [ Time Frame: Baseline, 12-month post-randomisation ]
    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.
  • ADHD Symptom Rating Scale-Version 1. [ Time Frame: Baseline, 12-month post-randomisation ]
    Self-report symptom checklist consisting of 18 DSM-IV criteria for parents. The checklist assesses occurrence frequency of each symptom.
  • Parenting Daily Hassles Scale. [ Time Frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation ]
    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.
  • Goal Based Outcomes. [ Time Frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation ]
    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.
  • EQ-5D-5L [ Time Frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation ]
    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.
  • Paediatric Quality of Life Inventory (PedsQL) [ Time Frame: Baseline, 12-month post-randomisation ]
    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.
  • Strengths and Difficulties Questionnaire (SDQ) [ Time Frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation ]
    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.
  • Participant service use [ Time Frame: 12-month post-randomisation ]
    Measured using diaries
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Primary efficacy outcome: Parental Sense of Competence Scale. [ Time Frame: Baseline, 12-months post-randomisation ]
    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.
  • Eyberg Child Behaviour Inventory. [ Time Frame: Baseline, 12-month post-randomisation ]
    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.
  • General Health Questionnaire. [ Time Frame: Baseline, 12-month post-randomisation ]
    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.
  • ADHD Symptom Rating Scale-Version 1. [ Time Frame: Baseline, 12-month post-randomisation ]
    Self-report symptom checklist consisting of 18 DSM-IV criteria for parents. The checklist assesses occurrence frequency of each symptom.
  • Parenting Daily Hassles Scale. [ Time Frame: Baseline, 12-month post-randomisation ]
    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.
  • Goal Based Outcomes. [ Time Frame: Baseline, 12-month post-randomisation ]
    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).
  • EQ-5D-5L [ Time Frame: Baseline, 12-month post-randomisation ]
    Self-report measure of parent quality of life. The EQ-5D-3L 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.
  • Participant service use [ Time Frame: 12-month post-randomisation ]
    Measured using diaries
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Support for PARents of Children Living With ADHD - a Research Trial
Official Title  ICMJE SPARCLAR: A Feasibility Randomised Controlled Trial of a Parenting Support Programme Focussed on Families Affected by ADHD
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel pilot RCT (MRC feasibility phase)
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Participants and assessors will be blind to treatment allocation.
Primary Purpose: Other
Condition  ICMJE Attention Deficit Disorder With Hyperactivity
Intervention  ICMJE
  • Behavioral: Parents InC
    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.
  • Behavioral: Incredible Years
    Also based on social learning theory but focus is not specifically on ADHD.
Study Arms  ICMJE
  • Experimental: Parents InC
    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.
    Intervention: Behavioral: Parents InC
  • Active Comparator: Incredible Years
    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: Behavioral: Incredible Years
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

• Parents of children aged 5-12 with a formal diagnosis of ADHD, following a standardised assessment from a paediatrician or a psychiatrist, referred to the Fife integrated ADHD pathway during the one year recruitment period will be eligible for inclusion.

Exclusion Criteria:

  • Families attending other parenting groups
  • Parents who have low proficiency in English (as this will compromise their ability to complete research measures or participate in a group intervention).
  • Participants already taking part in research on a parenting intervention will also be ineligible to participate.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fiona Sim 01413308254 sparclar@glasgow.ac.uk
Contact: Fatene Abakar Ismail 01413308254 sparclar@glasgow.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03832270
Other Study ID Numbers  ICMJE HIPS/17/58
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan 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.
Responsible Party Lucy Thompson, University of Glasgow
Study Sponsor  ICMJE University of Glasgow
Collaborators  ICMJE
  • NHS Fife
  • Chief Scientist Office of the Scottish Government
Investigators  ICMJE
Principal Investigator: Lucy Thompson University of Glasgow
Principal Investigator: Helen Minnis University of Glasgow
PRS Account University of Glasgow
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP