Contact information
Type
Scientific
Primary contact
Dr Maite Ferrin
ORCID ID
Contact details
Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO)
Dr Azpitarte 4
Edificio Licinio de la Fuente
4ª planta
Granada
18014
Spain
+34 958 02 02 45
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 Spain: evaluation of the efficacy in a randomised controlled trial
Acronym
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
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 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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
ADHD-symptoms by Conners Scale, measured at baseline, 12 weeks, 6 months, 9 months, and 15 months
Secondary outcome measures
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.
Overall trial start date
01/09/2009
Overall trial end date
01/09/2010
Reason abandoned
Eligibility
Participant 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)
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
01/09/2009
Recruitment end date
01/09/2010
Locations
Countries of recruitment
Spain
Trial participating centre
Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO)
Granada
18014
Spain
Sponsor information
Organisation
Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO) (Spain)
Sponsor details
Dr Azpitarte 4
edificio Licinio de la Fuente
4ª planta
Granada
18014
Spain
+34 958 02 02 45
pilar.martinez.exts@juntadeandalucia.es
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
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