NCT03832270

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

December 4, 2018

Last Update Submit

March 11, 2019

Conditions

Keywords

Parenting support

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (10)

  • Primary efficacy outcome: Parental Sense of Competence Scale.

    Baseline, 12-months post-randomisation

  • Eyberg Child Behaviour Inventory.

    Baseline, 12-month post-randomisation

  • General Health Questionnaire.

    Baseline, 12-month post-randomisation

  • ADHD Symptom Rating Scale-Version 1.

    Baseline, 12-month post-randomisation

  • Parenting Daily Hassles Scale.

    Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation

  • +5 more secondary outcomes

Study Arms (2)

Parents InC

EXPERIMENTAL

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

Incredible Years

ACTIVE COMPARATOR

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

Interventions

Parents InCBEHAVIORAL

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.

Parents InC

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

Incredible Years

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Fife Psychology Department

Dunfermline, Scotland, KY11 4UW, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Lucy Thompson

    University of Glasgow

    PRINCIPAL INVESTIGATOR
  • Helen Minnis

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and assessors will be blind to treatment allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel pilot RCT (MRC feasibility phase)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
International Research Coordinator & Research Fellow

Study Record Dates

First Submitted

December 4, 2018

First Posted

February 6, 2019

Study Start

January 21, 2019

Primary Completion

December 1, 2019

Study Completion

October 1, 2021

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations