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

NCT ID: NCT03832270

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-21
• Study Completion Date: 2021-10-31

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Parents InC

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Incredible Years

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Incredible Years

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Fife

OTHER_GOV

Sponsor Role: collaborator

Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role: collaborator

University of Glasgow

OTHER

Sponsor Role: lead

Responsible Party

Lucy Thompson

International Research Coordinator & Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucy Thompson

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Helen Minnis

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

NHS Fife Psychology Department

Dunfermline, Scotland, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Fiona Sim

Role: CONTACT

sparclar@glasgow.ac.uk

01413308254

Fatene Abakar Ismail

Role: CONTACT

sparclar@glasgow.ac.uk

01413308254

Facility Contacts

Hilary Maddox, Dr

Role: primary

hilarymaddox@nhs.net

01383565400

Caroline Hollinsworth

Role: backup

carolinehollinsworth@nhs.net

01383 565400

References

Sim F, Dalgarno L, McIntosh E, Haig C, Duklas P, McConnachie A, Gillberg C, Minnis H, Thompson L. Families with neurodevelopmental diagnoses are not 'Hard to Reach': Findings from a feasibility trial comparing parenting programmes for parents of children with ADHD. PLoS One. 2025 Sep 17;20(9):e0323959. doi: 10.1371/journal.pone.0323959. eCollection 2025.

Reference Type: DERIVED

PMID: 40961127 (View on PubMed)

Other Identifiers

HIPS/17/58

Identifier Type: -

Identifier Source: org_study_id