Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support

NCT01660425 | Unknown

• 2 other identifiers: ADHD-TEAM-022486738
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit-/Hyperactivity Disorder

Keywords

Attention deficit-/hyperactivity disorder; parenting enhancement training; guided self-help; methylphenidate

Outcome Measures

Primary Outcomes (1)

• Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating

  The WFIRS-P is used for the assessment of psychosocial functioning of children diagnosed with ADHD.

  baseline, six months, 12 months; 16 months (control group)

Secondary Outcomes (6)

• Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating

  baseline, six months, 12 months; 16 months (control group)

• Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent rating

  baseline, six months, 12 months; 16 months (control group)

• Change in Individual Problem Checklist (IPC), parent rating

  baseline, six months, 12 months; 16 months

• Change in Satisfaction with Medication Scale (SAMS), parent rating

  baseline, six months, 12 months; 16 months (control group)

• Change in "Compliance Scale", parent rating

  baseline, six months, 12 months; 16 months (control group)

Study Arms (2)

treatment as usual with MPH

NO INTERVENTION

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.

Psychosocial intervention

ACTIVE COMPARATOR

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.

Behavioral: Enhancement with psychosocial intervention

Interventions

Enhancement with psychosocial intervention BEHAVIORAL

Psychosocial intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead
• Shire: collaborator

Study Sites (1)

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

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (1)

• 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.

  PMID: 27878809 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Manfred Doepfner, PhD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leading psychologist at the Department of Childhood and Adolescence Psychiatry

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

DE (1)