|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Psychoeducation in families of children with attention deficit hyperactivity disorder (ADHD) in Spain |
| ISRCTN | ISRCTN32884424 |
| ClinicalTrials.gov identifier | |
| Public title | Psychoeducation in families of children with attention deficit hyperactivity disorder (ADHD) in Spain |
| Scientific title | Psychoeducation in families of children with attention deficit hyperactivity disorder (ADHD) in Spain: evaluation of the efficacy in a randomised controlled trial |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
1. Psychoeducation intervention 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 intervention 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 intervention in families of ADHD children/adolescents will lead to improvement of quality of life in these families in comparison with a control group |
| Lay summary | |
| Ethics approval | Local medical ethics committee (Complejo Hospitalario de Jaen, Spain) approved in September 2007 |
| Study design | Single centre randomised controlled double-blind parallel group trial |
| Countries of recruitment | Spain |
| Disease/condition/study domain | Attention deficit disorder (ADD)/attention deficit hyperactivity disorder (ADHD) |
| Participants - inclusion criteria |
1. Diagnosis of attention deficit disorder (ADD)/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 3 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) |
| Participants - 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 |
| Anticipated start date | 01/09/2009 |
| Anticipated end date | 01/09/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 70 (35 intervention group, 35 control group) |
| Interventions |
Psychoeducation intervention (experimental group):
Families of ADHD children/adolescents attending psychoeducation sessions. Psychoeducation provided by Child and Adolescent Psychiatrist and consisting of 12 weekly sessions, 90 minutes length, groups of 8 - 10 families. Sessions organisation: 1. 10 - 20 minutes: "warm-up" period, informal conversation, doubts from the previous session 2. 30 - 35 minutes: lecture on the topic 3. 10 minutes: brief pause 4. 30 - 40 minutes: topic discussion Participants encouraged to ask and make comments. Psychoeducation program for ADHD: Session 1: Presentations and group functioning rules. What is ADHD? Session 2: Core symptoms. Diagnostic procedures Session 3: Etiological, maintaining and perpetuating factors Session 4: Comorbidities in ADHD Session 5: Prognosis and outcome: ADHD in the adolescent and the adult Session 6: Executive function Session 7: Pharmacological treatments: stimulants and non-stimulants Session 8: Diets and other treatments Session 9: Cognitive behavioural treatment and other management approaches Session 10: Dealing with everyday-life problems at home I Session 11: Dealing with everyday-life problems at home II Session 12: Dealing with everyday-life problems at school Session 13: Summarising, final questions and doubts. Closing down session. Support group (active control group): Families of ADHD children/adolescents. Parents attending 12 weekly sessions, 90 minutes length, groups of 8 - 10 families, non-structured support groups provided by the same Child and Adolescent Psychiatrist. Control group only differs on the educational content provided. |
| Primary outcome measure(s) | ADHD-symptoms by Conners Scale, measured at baseline, 12 weeks, 6 months, 9 months, and 15 months |
| Secondary outcome measure(s) |
1. Attitudes Towards Treatment Questionnaire (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), 3th Edition Assessments on all measures pre-treatment and post-treatment. Follow-up assessment on all measures after 3 months, 6 months and 12 months. |
| Sources of funding |
1. The Alicia Koplowitz Foundation (Fundacion Alicia Koplowitz) (Spain)
2. Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref: ETS 07/90902) |
| Trial website | |
| Publications | |
| Contact name | Dr Maite Ferrin |
| Address |
Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO)
Dr Azpitarte 4, Edificio Licinio de la Fuente, 4ª planta |
| City/town | Granada |
| Zip/Postcode | 18014 |
| Country | Spain |
| Tel | +34 958 02 02 45 |
| Fax | +34 958 02 01 83 |
| maiteferrin@yahoo.es | |
| Sponsor | Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO) (Spain) |
| Address | Dr Azpitarte 4, edificio Licinio de la Fuente, 4ª planta |
| City/town | Granada |
| Zip/Postcode | 18014 |
| Country | Spain |
| Tel | +34 958 02 02 45 |
| Fax | +34 958 02 01 83 |
| pilar.martinez.exts@juntadeandalucia.es | |
| Sponsor website: | http://www.fibao.es/ |
| Date applied | 30/01/2010 |
| Last edited | 24/02/2010 |
| Date ISRCTN assigned | 24/02/2010 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|