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Home-based behavioral treatment for ADHD.


- candidate number10233
- NTR NumberNTR3021
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-aug-2011
- Secondary IDs15700.3010 / 2010.289; ZonMw / METC
- Public TitleHome-based behavioral treatment for ADHD.
- Scientific TitleEffectiveness of home treatment for children with ADHD, who have responded insufficiently to regular treatment: A randomized controlled study.
- ACRONYM
- hypothesisMost referred, school-aged children with attention-deficit/hyperactivity disorder (ADHD) profit well from treatment with medication, i.e behavioral parent training or a combination of both treatments. However, a considerable proportion of children do not respond sufficiently to these first line treatments. In Dutch clinical practice a next treatment step is to offer home-based treatment to address remaining disruptive behavior problems. Our clinical impression is that this treatment is successful. However, there is a lack of empirical evidence for the effectiveness of home-based treatment directed at behavior problems in children with ADHD.
Purpose of the study is to investigate the short-term effectiveness of a 4 month manualized home-based behavioral treatment for referred children with ADHD, aged 6 to 12 years, who have responded insufficiently to first line treatment with medication or behavioral parent training or a combination of both treatments. Our primary objective is to examine the improvement of disruptive behavior problems as reported by parents. Secondary objectives are to investigate long-term effectiveness, the effectiveness on secondary study parameters, and the effect of various psychosocial, cognitive, and biological moderators and mediators of treatment success.
- Healt Condition(s) or Problem(s) studiedADHD
- Inclusion criteria1. The child is 6 to 12 years old;
2. The child meets DSM-IV-TR (American Psychiatric Association, 1994) criteria for ADHD, any subtype, as determined through a semi-structured interview (such as the Parent’s Inventory of Children’s Symptoms [Schachar et al., 1994] and the Teacher Telephone Interview [Tannock et al., 1995] at time of referral;
3. The parents and/or the child have received psycho-education and have either started or considered pharmacological treatments directed at ADHD symptoms, and have at least made a start with outpatient behavioral parent training;
4. The child has a DSM-IV-TR Global Assessment of Functioningscore < 55, as determined by the last involved clinician;
5. The child has an intensity scale score > 130 and problem scale score > 2 (irrespective of item 36, i.e. referring to enuresis nocturna) on the Eyberg Child Behaviour Inventory completed by the primary care-taker;
6. The child has a total verbal, and performance IQ > 70 as assessed with a standardized intelligence test;
7. The legal parent(s) caretaker(s) have provided written consent for participating in the study, in accordance with the rules laid down in the Dutch “Wet medisch-wetenschappelijk onderzoek met mensen”.
- Exclusion criteria1. The child has a medical ailment, which prohibits participation in the study;
2. One of the parents/caretakers is unable to understand or imitate instructions;
3. The child is more than three days a week absent from the home of the parent(s) who participate in the treatment;
4.The family lives or is planning to move to a location more than one hour travel time from the Groningen Accare outpatient clinic;
5.The family has followed a form of home-based therapy through our center during the previous year.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2010
- planned closingdate1-nov-2013
- Target number of participants120
- Interventions1. Manualized intervention, a 14-16 weekly home-visits spread over four months and additional telephone sessions with their therapist twice a week, fully manualized behavioral treatment.
2. The control group is:
A. A home based care as usual (CAU) treatment with a variable content, length, and frequency of home-visits, or;
B. A waiting list condition, four months duration in line with regular waiting list.
- Primary outcomeParent reported disruptive behavior problems with Eyberg Child Behavior Inventory.
- Secondary outcomeMain secondary study parameters are children's internalizing problems (Child Behavior Checklist), parent reported impairment of child (Impairment Rating Scale-Parent-version), and parenting skills (Parent Practices Interview).
- Timepoints1. Baseline;
2. Intermediate measurements (Manualized treatment: after each treatment module; CAU treatment: after 4 months of treatment);
3. Directly post-treatment;
4. Follow up (6, 12 and 24 months after treatment).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES E. Nobel
- CONTACT for SCIENTIFIC QUERIES E. Nobel
- Sponsor/Initiator Accare, Division University Center for Child and Adolescent Psychiatry
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBackground:
Most referred, school-aged children with attention-deficit/hyperactivity disorder (ADHD) profit well from treatment with medication, i.e. behavioral parent training or a combination of both treatments. However, a considerable proportion of children do not respond sufficiently to these first line treatments. In Dutch clinical practice a next treatment step is to offer home-based treatment to address remaining disruptive behavior problems. Our clinical impression is that this treatment is often successful. However, there is a lack of empirical evidence for the effectiveness of home-based treatment directed at behavior problems in children with ADHD.

Objective:
To investigate the short-term effectiveness of a 4 month manualized home-based behavioral treatment for referred children with ADHD, aged 6 to 12 years, who have responded insufficiently to first line treatment with medication or behavioral parent training or a combination of both treatments. Our primary objective is to examine the improvement of disruptive behavior problems as reported by parents. Secondary objectives are to investigate long-term effectiveness, the effectiveness on secondary study parameters, and the effect of various psychosocial, cognitive, and biological moderators and mediators of treatment success.

Study design:
The study involves a randomized controlled trial (N=120), including three study conditions: (1) manualized treatment (n=40), (2) treatment with home based care as usual (CAU) treatment (n=40), and (3) a waiting list (n=40).

Study population:
Children with ADHD, aged 6 to 12 years, referred to our outpatient mental health clinic (University Center for Child- and Adolescent Psychiatry, Accare) who have not responded sufficiently to pharmacotherapy and/or behavioral parent training. Families who discontinued previous behavioral treatment or did not consent medication treatment will also be included.

Intervention:
The families in the condition with the manualized treatment will receive 14-16 weekly home-visits spread over four months and additional telephone sessions with their therapist twice a week. This treatment involves a fully manualized behavioral treatment. The families in the CAU-condition will receive home based treatment which is variable in content, length, and frequency of home-visits. The waiting-list-condition will have a duration of four months, in line with the regular waiting list, after which families will be allocated to home-based treatment. Other ongoing treatments will be allowed across all study arms.

Main study parameters:
Parent reported disruptive behavior problems. Main secondary study parameters are children’s internalizing problems, parent reported impairment of the child, and parenting skills.
- Main changes (audit trail)
- RECORD11-aug-2011 - 18-sep-2011


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