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

Attention Deficit Disorder With Hyperactivity Clinical Trial

— SPARCLAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03832270
• Other study ID #: HIPS/17/58
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: October 2021

Study information

• Verified date: March 2019
• Source: University of Glasgow
• Contact: Fiona Sim
• Phone: 01413308254
• Email: sparclar[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity

Intervention

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.
• Incredible Years
Also based on social learning theory but focus is not specifically on ADHD.

Locations

Country	Name	City	State
United Kingdom	NHS Fife Psychology Department	Dunfermline	Scotland

Sponsors (3)

Lead Sponsor	Collaborator
University of Glasgow	Chief Scientist Office of the Scottish Government, NHS Fife

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of parents recruited and retained.	Measured by number of parents recruited and retained throughout the study period.	Continuous over 1 year study period
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Participant service use	Measured using diaries	12-month post-randomisation