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

SPARCLAR: A Feasibility Randomised Controlled Trial of a Parenting Support Programme Focussed on Families Affected by ADHD

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.

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Behavioral: Parents InC; Behavioral: Incredible Years

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fiona Sim; Phone Number: 01413308254; Email: sparclar@glasgow.ac.uk
• Study Contact Backup: Name: Fatene Abakar Ismail; Phone Number: 01413308254; Email: sparclar@glasgow.ac.uk

Study Locations

• United Kingdom
  • Scotland
    • Dunfermline, Scotland, United Kingdom, KY11 4UW
      • Recruiting
      • NHS Fife Psychology Department
      • Contact: Hilary Maddox, Dr; Phone Number: 01383565400; Email: hilarymaddox@nhs.net
      • Contact: Caroline Hollinsworth; Phone Number: 01383 565400; Email: carolinehollinsworth@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Behavioral: Incredible Years; Also based on social learning theory but focus is not specifically on ADHD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of parents willing to be randomised to Parents InC or Incredible Years.	Measured by number of parents agreed to randomisation throughout the study period.	Continuous over 1 year study period
Number of parents recruited and retained.	Measured by number of parents recruited and retained throughout the study period.	Continuous over 1 year study period
Research procedures feasibility and acceptability	Face to face interviews will be conducted with participating families to assess the feasibility and acceptability of research procedures.	Continuous over 1 year study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy outcome: Parental Sense of Competence Scale.	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.	Baseline, 12-months post-randomisation
Eyberg Child Behaviour Inventory.	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.	Baseline, 12-month post-randomisation
General Health Questionnaire.	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.	Baseline, 12-month post-randomisation
ADHD Symptom Rating Scale-Version 1.	Self-report symptom checklist consisting of 18 DSM-IV criteria for parents. The checklist assesses occurrence frequency of each symptom.	Baseline, 12-month post-randomisation
Parenting Daily Hassles Scale.	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.	Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
Goal Based Outcomes.	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.	Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
EQ-5D-5L	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.	Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
Paediatric Quality of Life Inventory (PedsQL)	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.	Baseline, 12-month post-randomisation
Strengths and Difficulties Questionnaire (SDQ)	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.	Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
Participant service use	Measured using diaries	12-month post-randomisation

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: NHS Fife; Chief Scientist Office of the Scottish Government
• Investigators: Principal Investigator: Lucy Thompson, University of Glasgow

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (ACTUAL): February 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Parenting support
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: HIPS/17/58

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No