Condition category
Mental and Behavioural Disorders
Date applied
30/01/2010
Date assigned
24/02/2010
Last edited
05/08/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maite Ferrin

ORCID ID

Contact details

Department of Child and Adolescent Psychiatry
Developmental Neuropsychiatry Team at the Michael Rutter Centre
De Crespigny Park
Demark Hill
London
SE5 8AZ
United Kingdom
+44 (0)7765 557 465
maiteferrin@yahoo.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

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

Study design

Single-centre randomised controlled single-blind parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

ADHD symptoms by Conners Scale, measured at baseline, 12 weeks, 6 months and 9 months

Secondary outcome measures

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.

Overall trial start date

01/03/2010

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

70 (35 intervention group, 35 control group)

Participant 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

Recruitment start date

01/03/2010

Recruitment end date

01/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Child and Adolescent Psychiatry
London
SE5 8AZ
United Kingdom

Sponsor information

Organisation

Kings College London (UK)

Sponsor details

De Crespigny Park
Denmark Hill
London
SE5 8AZ
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Charity

Funder name

South London and Maudsley NHS Charitable Funds (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Alicia Koplowitz Foundation (Fundacion Alicia Koplowitz) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref: ETS 07/90902)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes