Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support

NCT ID: NCT01660425

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-03-31

Brief Summary

The main purpose of this study is to evaluate the effectiveness of a parenting enhancement training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity Disorder (ADHD) who are already medicated with methylphenidate.

Detailed Description

The main purpose of this study is to evaluate the effectiveness of a parenting enhancement training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity Disorder (ADHD) already medicated with methylphenidate (MPH). This particular PET was developed at the Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and has already been evaluated in several studies. MPH treatment has been proven to be efficacious in the reduction of ADHD symptoms. However, despite optimal titration a substantial percentage of children still suffer from residual symptoms and impairment in psychosocial functioning. Therefore, there is still room for improvement in satisfaction with medication. Moreover, a substantial rate of patients with good treatment effects fails to comply with medication during the course of treatment. This parenting enhancement training (PET) mainly conducted via written materials and telephone support will be introduced in patients already treated with MPH. Effects are expected on symptoms of ADHD as well as on comorbid oppositional symptoms. Further outcome parameters are satisfaction with medication and medication compliance of MPH treatment, psychosocial functioning as well as parenting skills. Parenting skills are a main focus of the PET and ADHD symptoms shall be improved through improving parenting skills. Besides focusing on symptoms, recent research often focuses on improvement of quality of life and impairment in psychosocial functioning (e. g. family, school, leisure time) as well. Not only suffer patients from the main symptoms. Many patients suffer as well from the symptoms' consequences, which is often an overall impairment. Satisfaction with medication and medication compliance are fundamental conditions for the success of a long term medical therapy. However, many studies show a lack of compliance.

Conditions

Attention Deficit-/Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment as usual with MPH

In the first twelve months of intervention the children receive treatment as usual with MPH and do not get any further intervention. Afterwards, the families get the opportunity to take part in the program which is then conducted for a duration of four months. Measurements are performed at the beginning of the program, after six moths, after 12 months and additionally after 16 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Psychosocial intervention

Parenting Enhancement Training as a form of psychosocial intervention is a guided program. Parents get the opportunity to discuss written information with a therapist in 20 minutes telephone calls. 14 telephone calls are offered. The whole intervention lasts for a period of one year. Booklets are mailed via post within the first 4 months. First 9 telephone calls are also within the first 4 months, usually every two weeks. Telephone calls 10 and 11 are within 5th or 6th month, telephone calls 12 to 14 are within 7th to 12th month with a two monthly time period in between.

Group Type: ACTIVE_COMPARATOR

Enhancement with psychosocial intervention

Intervention Type: BEHAVIORAL

Interventions

Enhancement with psychosocial intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• The child attends school and is aged 6 to 12
• Primary diagnosis of ADHD
• Medication with methylphenidate in stable doses for at least two months
• Currently, no change of medication is planned
• The parents are motivated to participate in the parenting enhancement training
• The parents have a command of written and spoken German
• Psychosocial impairment measured with WFIRS-P

Exclusion Criteria

• the family takes presumably part in psychotherapy with an intensive parenting training component during the duration of the intervention

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Manfred Doepfner

Leading psychologist at the Department of Childhood and Adolescence Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manfred Doepfner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne

Cologne, North Rhine-Westphalia, Germany

Countries

Germany

References

Dose C, Hautmann C, Buerger M, Schuermann S, Woitecki K, Doepfner M. Telephone-assisted self-help for parents of children with attention-deficit/hyperactivity disorder who have residual functional impairment despite methylphenidate treatment: a randomized controlled trial. J Child Psychol Psychiatry. 2017 Jun;58(6):682-690. doi: 10.1111/jcpp.12661. Epub 2016 Nov 23.

Reference Type: DERIVED

PMID: 27878809 (View on PubMed)

Other Identifiers

2486738

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ADHD-TEAM-02

Identifier Type: -

Identifier Source: org_study_id