Attention Deficit Disorder With Hyperactivity Clinical Trial
Official title:
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00202605 -
Safety and Efficacy of SPD465 in Adults With ADHD
|
Phase 2 | |
| Not yet recruiting |
NCT02677519 -
A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD
|
Phase 4 | |
| Completed |
NCT02730572 -
Concerta (Methylphenidate) -To-Generic Switch Study
|
N/A | |
| Completed |
NCT01681082 -
Psychological Effects of Tai Chi Training
|
N/A | |
| Active, not recruiting |
NCT01330693 -
Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy
|
Phase 3 | |
| Completed |
NCT00830700 -
Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study
|
N/A | |
| Completed |
NCT00626236 -
Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
|
Phase 2 | |
| Completed |
NCT01012622 -
An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD)
|
Phase 4 | |
| Completed |
NCT00598182 -
Adherence and Long-term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study
|
N/A | |
| Completed |
NCT00381407 -
Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder
|
N/A | |
| Completed |
NCT00247572 -
Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories
|
Phase 2 | |
| Completed |
NCT00178503 -
Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
|
Phase 2/Phase 3 | |
| Completed |
NCT00557011 -
NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD
|
Phase 2 | |
| Completed |
NCT00118911 -
Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder
|
N/A | |
| Completed |
NCT00218322 -
Effectiveness of ATMX in Treating Adolescents With ADHD and SUD
|
Phase 4 | |
| Completed |
NCT00071656 -
Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I
|
N/A | |
| Active, not recruiting |
NCT00057668 -
Preventing Behavior Problems in Children With ADHD
|
Phase 2 | |
| Completed |
NCT00050622 -
Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT00050050 -
Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
|
Phase 1 | |
| Completed |
NCT00031395 -
Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
|
Phase 3 |