Condition category
Mental and Behavioural Disorders
Date applied
20/10/2006
Date assigned
29/03/2007
Last edited
01/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas Warnke

ORCID ID

Contact details

Department of Child and Adolescent Psychiatry and Psychotherapy
Wuerzburg University Hospital
Fuechsleinstr. 15
Wuerzburg
D-97080
Germany
+49 (0)931 780 10
warnke@kjp.uni-weurzburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BMBF-ADHD-C2

Study information

Scientific title

Does the treatment of maternal Attention Deficit Hyperactivity Disorder enhance the effectiveness of parent management training for children's attention deficit hyperactivity disorder?

Acronym

AIMAC: (ADHD In Mothers And Children)

Study hypothesis

Attention Deficit Hyperactivity Disorder (ADHD) is a serious mental disorder with a persistent pattern of severely impaired attention and concentration, hyperactive and impulsive behaviour, emotional instability, restlessness and disorganised behaviour. The prevalence in childhood is estimated to be about 5% and in adulthood the prevalence is indicated to 2% and 4%.

ADHD is highly familial. About one quarter of children presenting with ADHD will have an ADHD parent, and more than half of all parents with ADHD will have a child with ADHD. Bringing up a child with ADHD can prove to be very stressful. Calm and consistent parenting in structured settings is especially important.

However, parents with ADHD are less likely to be able to provide such care. Parent's ADHD can be expected to have negative impact on parenting, family functioning, and the child. Parental ADHD may also have negative influence on the treatment outcome of childhood ADHD. This may especially be the case for the efficacy of parent management training, because parents with ADHD are expected to present difficulties in following instructions and in complying with the treatment regime.

Furthermore they tend to impulsively switch to alternative treatment plans promising quick cures, to act disorganised and argumentative or to have problems with the implementation of token economies and consistent rewards. Therefore, the control of ADHD symptoms in parents is supposed to be a prerequisite for the success of parenting programs for ADHD children.

The proposed study will be the first controlled multi-centre clinical trial investigating the effect of the treatment of maternal ADHD on the efficacy of parent management training for childhood ADHD.

The principal research question is: Does the treatment of maternal ADHD enhance the effectiveness of parent management training for children's ADHD?

Other questions to be addressed are:
1. To what extent does treatment effects generalise across problem areas (ADHD core-symptoms, externalising symptoms at home, family functioning, global symptom severity), settings (school and home environment) and rater-perspectives respectively (child, mother, teacher)?
2. Is there a greater acceptance of parent management training in mothers treated for ADHD?
3. Are the effects of treatment stable over time?
4. Does the sole treatment of maternal ADHD already have influences on the child’s symptoms?
5. Is there an association between the child's co-morbidity and treatment outcome?

The main hypothesis is: parent management training for children's ADHD is more effective in children whose mothers received treatment for adult ADHD as in children whose mothers did not.

Ethics approval

Ethics Committee of the faculty of medicine, Wuerzburg University, ref: 120/06

Study design

Randomised controlled trial, open study design, observer blinded

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Attention Deficit Hyperactivity Disorder (ADHD) in children and their mothers

Intervention

Two-armed design:
Experimental Group (EG): treatment of mother's ADHD with methylphenidate and a specific group psychotherapy program (12 weekly sessions, followed by monthly sessions, duration: 52 weeks)

Control Group (CG): clinical management for mother's ADHD without any specific pharmacological or psychotherapeutic interventions (12 weekly sessions, followed by monthly sessions, duration: 52 weeks)

In both groups - after week 13 - children and their mothers will receive parent management training to treat the child's ADHD (12 weekly sessions and two booster sessions).

Manualised cognitive-behavioural programs are used for group psychotherapy (ADHD mother) and parent management training (ADHD child). Trained therapists are treating mothers and children. Treatment integrity is ascertained by independent supervision.

Intervention type

Drug

Phase

Not Applicable

Drug names

Methylphenidate

Primary outcome measures

Primary endpoint is the extent of externalising symptoms in the children:
1. ADHD-ODD-Scale (ODD: Oppositional Defiant Disorder): number of symptoms of ADHD and ODD present during the last two weeks before assessment (ADHD-section and ODD-section of the Kiddie Schedule for Affective Disorders and Schizophrenia [KIDDIE-SADS], blind investigator-rating)

Secondary outcome measures

Children:
1. ADHD-section and ODD-section of the KIDDIE-SADS (diagnosis +/-, responders-nonresponders: 30 percent reduction of the ADHD-ODD-Scale, blind investigator-rating)
2. Externalising and internalising symptoms: Strength and Difficulties Questionnaire (SDQ) (mother and teacher report)
3. Family functioning: Home-Situations-Questionnaire (HSQ, mother-report)
4. Impact of the child's symptoms on the family: Family Impact Questionnaire (FIQ, mother-report)
5. Process-quality, related to parent training (Fragebogen zur Beurteilung der Behandlung,
FBB, mother- and therapist-report)

Mothers:
1. Symptom-Checklist (SCL-90-R, self-rating mother)
2. Conners Adult ADHD Rating Scale (CAARS-S:L, self-rating mother; CAARS-O:L, blind investigator rating)

Overall trial start date

01/01/2007

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All patients:
1. Voluntary and written informed consent of the mother, the child and other persons having the care and custody of the child

Children:
1. Aged six to 12 years
2. Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
3. No medication or on stable medication for at least four weeks before baseline assessment

Mothers:
1. Diagnosis of ADHD according to DSM-IV criteria
2. A score of 30 or more on the short version of the Wender-Utah-Rating-Scale
3. Aged 18 to 60 years, inclusive
4. Chronic course of ADHD symptoms from childhood to adulthood, onset of ADHD symptoms before the age of seven
5. No abnormality detected on physical examination, routine blood testing (blood count, renal, hepatic and thyroid function), Electrocardiogram (ECG) and Electroencephalogram (EEG)

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

To be randomised: 144 mother-child pairs

Participant exclusion criteria

All patients:
1. Participation in another clinical trial
2. Specific interventions for the treatment of ADHD within the last six months before screening
3. Need for inpatient treatment

Children:
1. Intelligence Quotient (IQ) less than 80
2. Pervasive developmental disorder, psychosis, schizophrenia, bipolar disorder, severe depressive episode

Mothers:
1. IQ less than 80
2. Schizophrenia, bipolar disorder, borderline personality disorder, antisocial personality disorder, suicidal or self-injurious behaviour, autism, motor tics, Tourette's syndrome
3. Substance abuse/dependence within six months prior to screening. Episodic abuse is not an exclusion criterion
4. Neurological diseases, seizures, glaucoma, uncontrolled hypertension
5. Current eating disorder/low weight (Body Mass Index [BMI] less than 20)
6. Pregnancy or breast-feeding

Recruitment start date

01/01/2007

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Wuerzburg University Hospital
Wuerzburg
D-97080
Germany

Sponsor information

Organisation

Wuerzburg University Hospital (Germany)

Sponsor details

Josef-Schneider-Strasse 2
Wuerzburg
D-97080
Germany

Sponsor type

Hospital/treatment centre

Website

http://www-i.klinik.uni-wuerzburg.de/deutsch/Home/content.html

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23070786
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26123832

Publication citations

  1. Results

    Jans T, Graf E, Jacob C, Zwanzger U, Gross-Lesch S, Matthies S, Perlov E, Hennighausen K, Jung M, Rösler M, Schulte-Altedorneburg M, von Gontard A, Hänig S, Sobanski E, Alm B, Poustka L, Bliznak L, Colla M, Gentschow L, Burghardt R, Salbach-Andrae H, Becker K, Holtmann M, Freitag C, Warnke A, Philipsen A, A randomized controlled multicentre trial on the treatment for ADHD in mothers and children: enrolment and basic characteristics of the study sample., Atten Defic Hyperact Disord, 2013, 5, 1, 29-40, doi: 10.1007/s12402-012-0092-4.

  2. Results

    Jans T, Jacob C, Warnke A, Zwanzger U, Groß-Lesch S, Matthies S, Borel P, Hennighausen K, Haack-Dees B, Rösler M, Retz W, von Gontard A, Hänig S, Sobanski E, Alm B, Poustka L, Hohmann S, Colla M, Gentschow L, Jaite C, Kappel V, Becker K, Holtmann M, Freitag C, Graf E, Ihorst G, Philipsen A, Does intensive multimodal treatment for maternal ADHD improve the efficacy of parent training for children with ADHD? A randomized controlled multicenter trial, J Child Psychol Psychiatry, 2015 , doi: 10.1111/jcpp.12443.

Additional files

Editorial Notes