Psychoeducation in families of children with attention deficit hyperactivity disorder (ADHD) in the United Kingdom

ISRCTN	ISRCTN26270684
DOI	https://doi.org/10.1186/ISRCTN26270684
Protocol serial number	N/A
Sponsor	Kings College London (UK)
Funders	South London and Maudsley NHS Charitable Funds (UK), The Alicia Koplowitz Foundation (Fundacion Alicia Koplowitz) (Spain), Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref: ETS 07/90902)

Submission date: 30/01/2010
Registration date: 24/02/2010
Last edited: 12/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Maite Ferrin
Scientific

Department of Child and Adolescent Psychiatry
Developmental Neuropsychiatry Team at the Michael Rutter Centre
De Crespigny Park
Demark Hill
London
SE5 8AZ
United Kingdom

Phone	+44 (0)7765 557 465
Email	maiteferrin@yahoo.es

Study information

Primary study design	Interventional
Study design	Single-centre randomised controlled single-blind parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Psychoeducation in families of children with attention deficit hyperactivity disorder (ADHD) in the United Kingdom: evaluation of the efficacy in a randomised controlled trial and a qualitative examination of the program
Study objectives	1. Psychoeducation program in families of attention deficit hyperactivity disorder (ADHD) children/adolescents will lead to a significant reduction of ADHD symptoms in these children in comparison with a control group 2. Psychoeducation program in families of ADHD children/adolescents will lead to improvement of treatment adherence rates in these children in comparison with a control group 3. Psychoeducation program in families of ADHD children/adolescents will lead to improvement of quality of life in these families in comparison with a control group
Ethics approval(s)	1. NHS Research Ethics Committee (NREC), 07/07/2009, ref: 09/H0723/20 2. Research and Development (R&D) Ethics Committee, 30/09/2009, ref: 2009/053
Health condition(s) or problem(s) studied	Attention deficit disorder (ADD)/attention deficit hyperactivity disorder (ADHD)
Intervention	Psychoeducation intervention (experimental group): Families of ADHD children/adolescents attending psychoeducation sessions. Psychoeducation provided by Child and Adolescent Psychiatrist and consisting of 6 weekly sessions, 120 minutes length, groups of 8 - 10 families. Sessions organisation: 1. 10 minutes: 'warm-up' period, informal conversation, doubts from the previous session 2. 45 minutes: lecture on the topic 3. 10 minutes: brief pause 4. 40 minutes: topic discussion Participants encouraged to ask and make comments. Psychoeducation program for ADHD (adapted from Psychoeducation in Bipolar Disorder): Session 1: Presentations and group functioning rules, what is ADHD?, core symptoms, diagnostic procedures Session 2: Aetiological, maintaining and perpetuating factors, comorbidities in ADHD Session 3: Prognosis and outcome - ADHD in the adolescent and the adult, executive function Session 4: Pharmacological treatments - stimulants and non-stimulants, diets and other treatments Session 5: Cognitive behavioural treatment and other management approaches, dealing with everyday-life problems at home I Session 6: Dealing with everyday-life problems at school, summarising, final questions and doubts, closing down session Posterior qualitative approach using Focus Group techniques to explore perceived efficacy of the psychoeducation program. Control group: Routine medical care including medication treatment and check-ups, crisis interventions, and parent counselling and support.
Intervention type	Other
Primary outcome measure(s)	ADHD symptoms by Conners Scale, measured at baseline, 12 weeks, 6 months and 9 months
Key secondary outcome measure(s)	1. Attitudes Towards Treatment by QATT 2. Adherence levels measured by direct questioning to families and pill counting (integrated into a composite) 3. Psychiatric conditions: Strengths and Difficulties Questionnaire (SDQ) 4. Children's Global Assessment Scale (C-GAS) 5. Clinical Global Impression (CGI) 6. Quality of life by PedsQL™ Core Version 4 and Cognitive Scale 7. Satisfaction with psychoeducation program by the Consumer Satisfaction Questionnaire 8. Parents Stress Index (PSI) 3rd Edition Assessments on all measures pre-treatment and post-treatment. Follow-up assessment on all measures after 3 months and 6 months.
Completion date	01/09/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	18 Years
Sex	All
Target sample size at registration	70
Key inclusion criteria	1. Diagnosis of attention deficit disorder (ADD)/attention deficit hyperactivity disorder (ADHD) in child (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition [DSM-IV]), with most of their co-morbidity represented (except for the exclusion criteria), and any treatment prescribed 2. Age of child between 4 and 19 years, either sex 3. Informed consent of the parents and the children available 4. Parents' age greater than or equal to 18 years 5. Responsibility and legal capacity in parents 6. Participant on clinical ADHD symptoms stabilisation for at least 1 month before entering the study (with or without medical treatment)
Key exclusion criteria	1. Severe Autistic Spectrum Disorders () 2. Severe learning disabilities () 3. Earlier or current participation in other intervention trials that might interfere with the current study (*) due to added problems to ADHD, thus requiring a different sort of intervention
Date of first enrolment	01/03/2010
Date of final enrolment	01/09/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Child and Adolescent Psychiatry

London
SE5 8AZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2020		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/04/2017: Publication reference added.