Psychoeducation in families of children with attention deficit hyperactivity disorder (ADHD) in the United Kingdom
| ISRCTN | ISRCTN26270684 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26270684 |
| Secondary identifying numbers | N/A |
- 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
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 |
|---|---|
| maiteferrin@yahoo.es |
Study information
| Study design | Single-centre randomised controlled single-blind parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/03/2010 |
| Completion date | 01/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 (35 intervention group, 35 control group) |
| 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
- England
- United Kingdom
Study participating centre
Department of Child and Adolescent Psychiatry
London
SE5 8AZ
United Kingdom
SE5 8AZ
United Kingdom
Sponsor information
Kings College London (UK)
University/education
University/education
De Crespigny Park
Denmark Hill
London
SE5 8AZ
England
United Kingdom
| Website | http://www.kcl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
South London and Maudsley NHS Charitable Funds (UK)
No information available
The Alicia Koplowitz Foundation (Fundacion Alicia Koplowitz) (Spain)
No information available
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref: ETS 07/90902)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
12/04/2017: Publication reference added.
