NCT04832737

Brief Summary

The aim of the research is to develop a treatment program with positive self-awareness and self-determination outcomes for adults with Attention Deficit Hyperactivity Disorder (ADHD). Current treatments are based in a characterisation of ADHD oriented on deficits impairing everyday functioning, with primary goals of symptom control and reduction. However, treatment approaches are not standardised and only evidence short-term effectiveness. This project proposes an alternative approach to understanding ADHD behaviours, supported by Self Determination Theory (SDT). Research shows SDT based treatment approaches can support engagement of intrinsic motivation and longterm integration of behavioural change. ADHD research shows individuals are impaired in some contexts but not in others and can manage well, indicating potential for ADHD neurodiverse "strengths" which could be developed and supported. Recent psychology research recommends cultivating positive psychological factors and emotions to improve mental health and wellbeing. Adults aged 18+ with a confirmed ADHD diagnosis will be invited to participate in two projects: Intensive online interviews of 1 hour will be conducted to identify, explore, and construct a theory about the factors, or "natural strengths" in lived experience of ADHD that help individuals to overcome everyday impairments. These factors will be incorporated into a pilot feasibility study of an SDT based 12-week treatment programme focusing on understanding the lived experience of ADHD and building on these strengths. The treatment will be designed for individual participants and delivered online. This study will have two sets of participants: one group will go directly to treatment, the other will go on a 12-week waiting list to create a comparison group. The second group will then be offered the 12-week treatment. Measures of experience of the participants will be looking for the feasibility, acceptability and efficacy of this treatment, as well as indicators of symptom improvement, and changes in self-awareness and self-regulation skills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

2 active sites

Status
completed

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

March 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 6, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

March 29, 2021

Last Update Submit

May 16, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Weiss Functional Impairment Rating Scale -WFIRS

    Measures change in severity of ADHD symptoms. Lilkert scale where the total score can be reviewed, or a mean score from each relevant domain. Higher scores mean worse outcome.

    Baseline and immediately after intervention

  • Patient Heath Questionniare (PHQ)- 9

    Major Depressive Disorder section of larger PHQ measuring change in severity of Depression symptoms. Minimim score 0, maximum score 27, higher scores mean worse outcome.

    Baseline and immediately after intervention

  • General Anxiety Disorder (GAD) 7

    Measures change in severity of Anxiety symptoms. Scale score ranges from 0 to 21 with cut points of 5, 10, and 15 that might be interpreted as representing mild, moderate, and severe levels of anxiety. Higher scores mean worse outcome.

    Baseline and immediately after intervention

  • Harter's Self Perception Profile

    Measures changes in self awareness. Each item has minimum score of 1, maximum score of 4. Mean scores are calculated for each of 12 sub-domains. Higher scores mean better outcome.

    Baseline and immediately after intervention

  • Index of Autonomous Functioning -IAF

    Measures changes in feeling self-determined. Each item scores minimum 1, maximum 5 and total is calculated by averaging scores from 15 items. Higher scores mean better outcome.

    Baseline and immediately after intervention

  • Perceived Choice and Awareness of Self Scale -PCASS

    Measures changes in feeling self-determined. Likert 10-item scale, with two 5-item subscales with minimum of 1 and maximum of 5 on each item. Total is calculated by averaging scores in each subscale, with higher scores meaning a better outcome.

    Baseline and immediately after intervention

  • Personal Questionnaire - PQ

    Measure change in participant selected specific psychological difficulties. 10 problems are measured weekly with score of minimum 1, maximum 7. Total is calculated by averaging scores in each subscale, with higher scores meaning a better outcome.

    During the intervention

Study Arms (2)

Intervention

EXPERIMENTAL

SDT theory-based psychotherapeutic treatment model

Behavioral: ADDapt Ability Framework

Control

NO INTERVENTION

Wait List

Interventions

12 week individual therapeutic coaching intervention

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of ADHD
  • Age 18 or older
  • Access to computer or smartphone with an internet connection

You may not qualify if:

  • Co-morbid diagnosis (e.g. Autism, Bi-polar, Learning Disabilities, Traumatic Brain Injury, Psychosis or Tourette's)
  • Substance abuse disorders
  • Other mental health disorders (e.g. PTSD, Oppositional Defiant Disorder
  • Personality Disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Huddersfield

Huddersfield, West Yorkshire, HD1 3DH, United Kingdom

Location

Manygates Adult ADHD Clinic

Wakefield, West Yorkshire, WF1 5PN, United Kingdom

Location

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MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Barry Tolchard

    University of Huddersfield

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a wait list control study design with pre-, within, and post-treatment measures. A rolling entry of participants will be conducted, where once individuals have been screened their entry into the study will begin. A maximum of 30 adults aged 18+ with a confirmed diagnosis of ADHD will be allocated using block randomisation to the SDT theory-based model or wait list over a 12-week period. Following the 12-week wait, the wait list group will also be enrolled in the SDT theory-based model. This ensures all participants receive the opportunity to experience the treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 6, 2021

Study Start

September 6, 2021

Primary Completion

April 17, 2023

Study Completion

April 17, 2023

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

To protect identity of individual participants, all personally identifiable data (PID) will be anonymised and will not be released. All participant case records will be held in accordance with the Data Protection Act. Records will be kept both in electronic and hard copy form. The participants' home addresses and telephone numbers will be kept on a secure database and spreadsheet on NHS/University computers in compliance to the Data Protection Act. Data held in the NVivo database will be anonymised and only accessible by password protected researcher login. All manual records will be kept in a locked cabinet accessible by the researcher only. In accordance with the Data Protection Act personal data will not be retained for longer than is necessary. The University of Huddersfield recommends that data is stored for 10 years to aid transparency and integrity of research. Long term storage of data will be accessible by the researcher only.

Locations