Psychoeducation in families of children with attention deficit hyperactivity disorder (ADHD) in Spain

ISRCTN	ISRCTN32884424
DOI	https://doi.org/10.1186/ISRCTN32884424
Protocol serial number	N/A
Sponsor	Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO) (Spain)
Funders	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: 24/02/2010

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Maite Ferrin
Scientific

Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO)
Dr Azpitarte 4, Edificio Licinio de la Fuente, 4ª planta
Granada
18014
Spain

Phone	+34 958 02 02 45
Email	maiteferrin@yahoo.es

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled double-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 Spain: evaluation of the efficacy in a randomised controlled trial
Study objectives	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(s)	Local medical ethics committee (Complejo Hospitalario de Jaen, Spain) approved in September 2007
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 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
Primary outcome measure(s)	ADHD-symptoms by Conners Scale, measured at baseline, 12 weeks, 6 months, 9 months, and 15 months
Key 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.
Completion date	01/09/2010

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)/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)
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	01/09/2009
Date of final enrolment	01/09/2010

Locations

Countries of recruitment

Spain

Study participating centre

Fundacion para la Investigacion Biosanitaria de Andalucia Oriental (FIBAO)

Granada
18014
Spain

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes