Clinical trial NCT03832270: Support for PARents of Children Living With ADHD - a Research Trial
Official title: SPARCLAR: A Feasibility Randomised Controlled Trial of a Parenting Support Programme Focussed on Families Affected by ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Parenting support
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: NHS Fife
name: Chief Scientist Office of the Scottish Government
First posted: 2019-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel pilot RCT (MRC feasibility phase)
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of parents willing to be randomised to Parents InC or Incredible Years.
timeFrame: Continuous over 1 year study period
measure: Number of parents recruited and retained.
timeFrame: Continuous over 1 year study period
measure: Research procedures feasibility and acceptability
timeFrame: Continuous over 1 year study period
Secondary outcomes:
measure: Primary efficacy outcome: Parental Sense of Competence Scale.
timeFrame: Baseline, 12-months post-randomisation
measure: Eyberg Child Behaviour Inventory.
timeFrame: Baseline, 12-month post-randomisation
measure: General Health Questionnaire.
timeFrame: Baseline, 12-month post-randomisation
measure: ADHD Symptom Rating Scale-Version 1.
timeFrame: Baseline, 12-month post-randomisation
measure: Parenting Daily Hassles Scale.
timeFrame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
measure: Goal Based Outcomes.
timeFrame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
measure: EQ-5D-5L
timeFrame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
measure: Paediatric Quality of Life Inventory (PedsQL)
timeFrame: Baseline, 12-month post-randomisation
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
measure: Participant service use
timeFrame: 12-month post-randomisation
Other outcomes:
Locations:
city: Dunfermline
country: United Kingdom
facility: NHS Fife Psychology Department
state: Scotland
Study officials:
affiliation: University of Glasgow
name: Lucy Thompson
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Helen Minnis
role: PRINCIPAL_INVESTIGATOR
References: