Abstract
Parental ADHD may be a significant barrier to a successful treatment for the child’s ADHD. The objective of our randomized controlled trial was to evaluate whether the treatment for maternal ADHD improves the efficacy of a behavioural parent training for children’s ADHD. Patient enrolment and a description of the full analysis set (FAS) of mother–child pairs with non-missing baseline data are presented. One hundred and forty-four mother–child pairs were randomized to two treatments for maternal ADHD: cognitive behavioural group psychotherapy plus open methylphenidate treatment or control treatment (supportive counselling). After 3 months of treatment for maternal ADHD, mother–child pairs participated in a behavioural parent–child training. Assessment for eligibility included standardized instruments. After pre-screening out of 444 mother–child pairs, 206 were evaluated for trial participation and 144 were randomized. The FAS was built up by 143 dyads (children: mean age 9.4 years, 73 % males; mothers: mean age: 38.3 years). Fifty-two per cent of the children and 66 % of the mothers had combined ADHD subtype. Current axis-I co-morbidity rates were 48 % in children and 31 % in mothers. Maternal axis-II co-morbidity was 20.1 %. Fifty-seven per cent of the mothers lived together with the father of the index-child, and 29 % were single mothers. Sixty-two per cent had part-time or full-time employment. There was a selection bias excluding mothers with lack of time and effort for participation and mothers affected by coexisting mental and physical illness. Nevertheless, for our trial we were able to collect a sample comparable to routine psychiatric outpatient settings (registration: CCT-ISRCTN73911400, funding: BMBF-01GV0605).
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Acknowledgments
Our network on psychotherapy of ADHD is supported by the German Federal Ministry of Education and Research (BMBF; 01GV0605, 01GV0606) within the framework ‚research networks on psychotherapy. We thank Dr. Fischer (MEDICE Arzneimittel Puetter GmbH & Co. KG) for his advice in preparing the study protocol and case report forms as well as his assistance in SAE management. Prof. Dr. F. Mattejat gave helpful expert advice in planning the study. We are also grateful that HOGREFE and BELTZ publishers provided treatment manuals for free. We gratefully thank all participating families and all our partners for their cooperation.
Conflict of interest
T Jans: None; E Graf: None; C Jacob has received speaker’s honoraria by Medice and is member of the Adivisory Bord AADHD of this company; U Zwanzger: None; S Groß-Lesch: None; S Matthies received speakers fees by Janssen-Cilag and has been involved in clinical trials conducted by Janssen-Cilag and Lilly; E Perlov: None; K Hennighausen: None; M Jung has not received any industrial honoraria; M Rösler is member of the speakers bureau of Medice, Janssen and Shire; he is a member of the advisory boards of Lilly, Shire, Medice and Janssen. He has performed clinical trials for Medice and Lilly; M Schulte-Altedorneburg: None; A von Gontard: None; S Hänig: None; E Sobanski: advisory boards, IITs, lectures or Phase-III-studies within the last 3 years: Medice, Shire, Eli Lilly and Novartis; B. Alm: advisory boards, lectures or phase-III-studies within the last 3 years: Medice, Eli Lilly; L Poustka has received speaker’s honoraria by Ely Lilly and Shire during the last 3 years; L Bliznak: None; M Colla: advisory boards, speaker’s honoraria or phase-III studies within the last 3 years: Shire, Eli Lilly and Novartis; L Gentschow: None; R Burghardt: 2009 till 2011—unrestricted research grant of Charité University Medicin Berlin; H Salbach-Andrae: None; K Becker: Prof. Katja Becker is/has been involved in research/clinical trials with Ely Lilly and Shire, is on the Advisory Board of Eli Lilly/Germany, was paid for public speaking by Eli Lilly and Shire and received conference attendance support from Shire and Eli Lilly; M Holtmann served in an advisory or consultancy role for Lilly, Novartis, Shire and Bristol-Myers Squibb and received conference attendance support or was paid for public speaking by AstraZeneca, Bristol-Myers Squibb, Janssen-Cilag, Lilly, Medice, Neuroconn, Novartis and Shire; C Freitag has received speaker’s honoraria by Eli Lilly and Novartis during the last 3 years. She was an independent clinical consultant for Desitin in 2010; A Warnke received speakers fees by Janssen-Cilag, Medice, Novartis and Lilly and has been involved in clinical trials conducted by Lilly, Novartis, Medice and Shire; A Philipsen: advisory boards, lectures, phase-III studies or travel grants within the last 3 years: Eli Lilly, Janssen-Cilag, Medice, Novartis and Shire.
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This study was conducted by the AIMAC study group.
Please refer the “Appendix” section for AIMAC group members.
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Appendix
Members of the AIMAC study group (ADHD in Mothers and Children; coordinating investigator: Prof. Dr. A. Warnke, Wuerzburg University Hospital) are our colleagues at the study sites at Freiburg (University Medical Center Freiburg: Department of Psychiatry and Psychotherapy, Director: Prof. Dr. M. Berger; Department of Child and Adolescent Psychiatry and Psychotherapy, Director: Prof. Dr. E. Schulz), Homburg (Saarland University Hospital and Saarland University Faculty of Medicine: Institute for Forensic Psychology and Psychiatry, Director: Prof. Dr. M. Roesler; Department of Child and Adolescent Psychiatry and Psychotherapy, Director: Prof. Dr A. v. Gontard), Mannheim (Central Institute for Mental Health: Clinic for Psychiatry and Psychotherapy, Director: Prof. Dr. A. Meyer-Lindenberg; Clinic for Child and Adolescent Psychiatry and Psychotherapy, Director: Prof. Dr. Dr. T. Banaschewski), Berlin (Charité - University Medicine, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy, Director: Prof. Dr. I. Heuser; Campus Virchow-Klinikum, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Director: Prof. Dr. U. Lehmkuhl), Wuerzburg (Wuerzburg University Hospital: Department of Psychiatry, Psychosomatics and Psychotherapy, Director: Prof. Dr. J. Deckert; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Director: Prof. Dr. M. Romanos), members of the Clinical Trials Unit at University Medical Center Freiburg (Director: R. Bredenkamp) as well as members of the Data Monitoring and Safety Committee (Prof. Dr. Dr. H. Remschmidt, Prof. Dr. G. Wassmer, PD Dr. N. Wodarz). Independent supervision is carried out by staff members at the Department of Child and Adolescent Psychiatry and Psychotherapy at the Cologne University Hospital (parent training) and at the Institute for Psychology of Freiburg University in cooperation with colleagues in private practice (treatment of mothers). Other projects in our network on psychotherapy research in ADHD (speaker: Prof. Dr. A. Warnke, Wuerzburg University Hospital) are coordinated by PD Dr. A. Philipsen (University Medical Center Freiburg, Psychotherapy of adult ADHD), Prof. Dr. L. Tebartz van Elst (University Medical Center Freiburg, functional and morphometric brain mapping) and Prof. Dr. K.-P. Lesch (Wuerzburg University Hospital, molecular genetics).
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Jans, T., Graf, E., Jacob, C. et al. A randomized controlled multicentre trial on the treatment for ADHD in mothers and children: enrolment and basic characteristics of the study sample. ADHD Atten Def Hyp Disord 5, 29–40 (2013). https://doi.org/10.1007/s12402-012-0092-4
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DOI: https://doi.org/10.1007/s12402-012-0092-4