Attention Deficit Hyperactivity DisorderD'SNAPPNCT01684644
A Controlled Study of Parent Training in the Treatment of ADHD in Young Children
A study testing New Forest Parenting Programme and Treatment as usual in people with Attention Deficit Hyperactivity Disorder, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effectiveness of parent training in the treatment of ADHD in young children (ages 3-7) referred to Danish child mental health services. Medication is not recommended as first-line treatment for young children with ADHD. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- New Forest Parenting Programme and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A clinical diagnosis of ADHD, as measured by the DAWBA
- Participants first language must be Danish
Who cannot join
- Children with intellectual disabilities (i.e. IQ < 70), Autism Spectrum Disorders.
- Severe parental psychiatric disorder
- Severe social adversity, as defined by social services involvement due to suspicions of or detected neglect.
- Child receiving medication or other treatment for ADHD symptoms
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for child and adolescent psychiatry
Risskov, Aarhus, 8240
About this study
Official title: Parent Training for Preschool ADHD: A Randomised Controlled, Multicentre Effectiveness Trial of the New Forest Parenting Programme in a Clinical Sample of Danish Children
The purpose of this study is to investigate the effectiveness of parent training in the treatment of ADHD in young children (ages 3-7) referred to Danish child mental health services. Medication is not recommended as first-line treatment for young children with ADHD. Parent training is recommended, but has not been formally introduced or established in Denmark. The study will investigate the effectiveness of a parent training programme specifically developed to target ADHD symptoms in young children; The New Forest Parenting Programme, against Treatment as Usual for children diagnosed with ADHD at two different child mental health clinics in Denmark.
Read the detailed description
Description: A study to: 1) Address the need for non-pharmacological treatment in young children with ADHD and 2) Address the need for the development of evidence-based psychosocial treatment interventions in Danish child mental health services, through the implementation of the New Forest Parenting Programme (NFPP).
Rationale: ADHD is a neuro-developmental disorder with symptoms frequently occurring in early childhood. ADHD is associated with long-term personal, psychosocial sequalae. ADHD presents a considerable societal cost burden, both for mental health services, but also in areas such as education, employment, the criminal justice system. Pharmacological treatment of preschool ADHD is not recommended as first-line treatment, due to a number of reasons, including lack of evidence for efficacy, parental concerns, side effects on growth rates, and the unknown long-term implications for the developing brain. Effective psychosocial treatments for ADHD are therefore of central public priority generally, and for child mental health services, specifically. Currently, psychosocial interventions for ADHD in pre-school children in Danish Child and Adolescent Mental Health Services (CAMHS) are not well described or systematically developed. There is a pressing need to develop evidence-based psycho-social treatments for young children with ADHD in Danish CAMHS.
Design: The study will be a randomised controlled multi-centre effectiveness trial comparing NFPP intervention to a Treatment as Usual control group. The trial will recruit 200 preschool children (aged 3-6) with a diagnosis of ADHD from two Danish outpatient child mental health service sites. Participants will be randomised to either 1) NFPP over a period of 8 weeks or 2) a control group receiving Treatment as Usual (TAU). Outcome: The primary outcome measure will be child ADHD symptoms. Secondary outcomes include parental wellbeing, child quality of life, parent-child interactions. Measures will be collected at three time points to track changes in outcome: T1: Before start of intervention or TAU condition. T2: Directly after the intervention or TAU and T3: 6 month follow-up after T1 for both arms of the trial. The study will perform exploratory moderator and mediator analyses.
Expertise: The study receives external consultation from an international expert team for the planning, execution, NFPP training and supervision. The team consists of research and clinical experts in the treatment and evaluation of interventions for preschool ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- New Forest Parenting Programme, Treatment as usual
- Keywords
- ADHD, Parent Training, RCT, Preschool
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Forest Parenting ProgrammeBehavioural
Treatment as usualBehavioural
Also called Psychoeducation in groups for parents of young children diagnosed with ADHD
| Study group | Role | What they receive |
|---|---|---|
| New Forest Parenting Programme | Experimental | The New Forest Parenting Programme is a parent training programme specifically developed to treat ADHD in preschool children. The programme is delivered as an 8 week intervention for individual parents and their child. Receives: Behavioral: New Forest Parenting Programme |
| Treatment as Usual | Other | Treatment as usual for preschool ADHD consists of psychoeducation groups for parents. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Rating Scale IV-Preschool Version
A screening instrument for the symptoms of AD/HD in the preschool population.
Measured: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Secondary outcomes (6)
Preschool ADHD-RS (Teacher completed) 18 items
screening instrument for the symptoms of AD/HD in the preschool population.
Measured: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Strength and Difficulties Questionnaire (parent version)
A brief measure of prosocial behaviour and and psychopathology of 3-16 year olds that can be completed by parents
Measured: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Strength and Difficulties Questionnaire (teacher completed)
A brief measure of prosocial behaviour and and psychopathology of 3-16 year olds that can be completed by teachers
Measured: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Child solo play - observation measure -
Observation measure: Index of Attention scale assessed from 'time on task'/no. of switches in activity' with high scores representing more attention and less switching
Measured: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Child Health Questionnaire (CHQ-28)
Quality of life measure
Measured: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Family Strain Index 6 items
Short screening instrument for the detection of family strain
Measured: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, TrygFonden, Denmark, Sygekassernes Helsefond
- Responsible party
- Sponsor
- Investigators
- Per Hove Thomsen, MD, Study chair, Børne- og Ungdomspsykiatrisk Center-Risskov, Aarhus Universitetshospital, Skovagervej 2, 8240 Risskov, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684644
- Sponsor's protocol ID
- 7-10-1294
- Other IDs
- 7-10-1294
- Acronym
- D'SNAPP
- Status last verified
- Jun 2017
- First submitted
- 4 Sep 2012
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Larsen LB, Daley D, Lange AM, Sonuga-Barke E, Thomsen PH, Rask CU. Effect of Parent Training on Health-Related Quality of Life in Preschool Children With Attention-Deficit/Hyperactivity Disorder: A Secondary Analysis of Data From a Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2021 Jun;60(6):734-744.e3. doi: 10.1016/j.jaac.2020.04.014. Epub 2020 Jun 4.
PubMed 32505701Lange AM, Daley D, Frydenberg M, Houmann T, Kristensen LJ, Rask C, Sonuga-Barke E, Sondergaard-Baden S, Udupi A, Thomsen PH. Parent Training for Preschool ADHD in Routine, Specialist Care: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2018 Aug;57(8):593-602. doi: 10.1016/j.jaac.2018.04.014. Epub 2018 Jun 18.
PubMed 30071980Lange AM, Daley D, Frydenberg M, Rask CU, Sonuga-Barke E, Thomsen PH. The Effectiveness of Parent Training as a Treatment for Preschool Attention-Deficit/Hyperactivity Disorder: Study Protocol for a Randomized Controlled, Multicenter Trial of the New Forest Parenting Program in Everyday Clinical Practice. JMIR Res Protoc. 2016 Apr 13;5(2):e51. doi: 10.2196/resprot.5319.
PubMed 27076496
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Training for Preschool ADHD: A Randomised Controlled, Multicentre Effectiveness Trial of the New Forest Parenting Programme in a Clinical Sample of Danish Children
- ClinicalTrials.gov ID
- NCT01684644
- Acronym / sponsor ID
- D'SNAPP / 7-10-1294
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Parent Training, RCT, Preschool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, TrygFonden, Denmark, Sygekassernes Helsefond
- Study start
- Sep 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effectiveness of parent training in the treatment of ADHD in young children (ages 3-7) referred to Danish child mental health services. Medication is not recommended as first-line treatment for young children with ADHD. Parent training is recommended, but has not been formally introduced or established in Denmark. The study will investigate the effectiveness of a parent training programme specifically developed to target ADHD symptoms in young children; The New Forest Parenting Programme, against Treatment as Usual for children diagnosed with ADHD at two different child mental health clinics in Denmark.
Detailed description
Description: A study to: 1) Address the need for non-pharmacological treatment in young children with ADHD and 2) Address the need for the development of evidence-based psychosocial treatment interventions in Danish child mental health services, through the implementation of the New Forest Parenting Programme (NFPP).
Rationale: ADHD is a neuro-developmental disorder with symptoms frequently occurring in early childhood. ADHD is associated with long-term personal, psychosocial sequalae. ADHD presents a considerable societal cost burden, both for mental health services, but also in areas such as education, employment, the criminal justice system. Pharmacological treatment of preschool ADHD is not recommended as first-line treatment, due to a number of reasons, including lack of evidence for efficacy, parental concerns, side effects on growth rates, and the unknown long-term implications for the developing brain. Effective psychosocial treatments for ADHD are therefore of central public priority generally, and for child mental health services, specifically. Currently, psychosocial interventions for ADHD in pre-school children in Danish Child and Adolescent Mental Health Services (CAMHS) are not well described or systematically developed. There is a pressing need to develop evidence-based psycho-social treatments for young children with ADHD in Danish CAMHS.
Design: The study will be a randomised controlled multi-centre effectiveness trial comparing NFPP intervention to a Treatment as Usual control group. The trial will recruit 200 preschool children (aged 3-6) with a diagnosis of ADHD from two Danish outpatient child mental health service sites. Participants will be randomised to either 1) NFPP over a period of 8 weeks or 2) a control group receiving Treatment as Usual (TAU). Outcome: The primary outcome measure will be child ADHD symptoms. Secondary outcomes include parental wellbeing, child quality of life, parent-child interactions. Measures will be collected at three time points to track changes in outcome: T1: Before start of intervention or TAU condition. T2: Directly after the intervention or TAU and T3: 6 month follow-up after T1 for both arms of the trial. The study will perform exploratory moderator and mediator analyses.
Expertise: The study receives external consultation from an international expert team for the planning, execution, NFPP training and supervision. The team consists of research and clinical experts in the treatment and evaluation of interventions for preschool ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Forest Parenting Programme | Experimental | Behavioral: New Forest Parenting ProgrammeThe New Forest Parenting Programme is a parent training programme specifically developed to treat ADHD in preschool children. The programme is delivered as an 8 week intervention for individual parents and their child. |
| Treatment as Usual | Other | Behavioral: Treatment as usualTreatment as usual for preschool ADHD consists of psychoeducation groups for parents. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- A clinical diagnosis of ADHD, as measured by the DAWBA
- Participants first language must be Danish
Key exclusion criteria (4 listed)
- Children with intellectual disabilities (i.e. IQ < 70), Autism Spectrum Disorders.
- Severe parental psychiatric disorder
- Severe social adversity, as defined by social services involvement due to suspicions of or detected neglect.
- Child receiving medication or other treatment for ADHD symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Forest Parenting Programme | Behavioural | New Forest Parenting Programme |
| Treatment as usualAlso: Psychoeducation in groups for parents of young children diagnosed with ADHD | Behavioural | Treatment as Usual |
Primary outcome
ADHD Rating Scale IV-Preschool Version
Time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
A screening instrument for the symptoms of AD/HD in the preschool population.
6 secondary outcomes
Preschool ADHD-RS (Teacher completed) 18 items
Time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Strength and Difficulties Questionnaire (parent version)
Time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Strength and Difficulties Questionnaire (teacher completed)
Time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Child solo play - observation measure -
Time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Child Health Questionnaire (CHQ-28)
Time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Family Strain Index 6 items
Time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Derived from this study: PubMed 32505701Larsen LB, Daley D, Lange AM, Sonuga-Barke E, Thomsen PH, Rask CU. Effect of Parent Training on Health-Related Quality of Life in Preschool Children With Attention-Deficit/Hyperactivity Disorder: A Secondary Analysis of Data From a Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2021 Jun;60(6):734-744.e3. doi: 10.1016/j.jaac.2020.04.014. Epub 2020 Jun 4.
- Derived from this study: PubMed 30071980Lange AM, Daley D, Frydenberg M, Houmann T, Kristensen LJ, Rask C, Sonuga-Barke E, Sondergaard-Baden S, Udupi A, Thomsen PH. Parent Training for Preschool ADHD in Routine, Specialist Care: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2018 Aug;57(8):593-602. doi: 10.1016/j.jaac.2018.04.014. Epub 2018 Jun 18.
- Derived from this study: PubMed 27076496Lange AM, Daley D, Frydenberg M, Rask CU, Sonuga-Barke E, Thomsen PH. The Effectiveness of Parent Training as a Treatment for Preschool Attention-Deficit/Hyperactivity Disorder: Study Protocol for a Randomized Controlled, Multicenter Trial of the New Forest Parenting Program in Everyday Clinical Practice. JMIR Res Protoc. 2016 Apr 13;5(2):e51. doi: 10.2196/resprot.5319.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Hove Thomsen, MD study chair
Børne- og Ungdomspsykiatrisk Center-Risskov, Aarhus Universitetshospital, Skovagervej 2, 8240 Risskov, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Forest Parenting Programme and Treatment as usual in people with Attention Deficit Hyperactivity Disorder, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Rating Scale IV-Preschool Version (time frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01684644, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.