A Controlled Study of Parent Training in the Treatment of ADHD in Young Children (D'SNAPP)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
New Forest Parenting Programme
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Parent Training, RCT, Preschool
Eligibility Criteria
Inclusion Criteria:
- A clinical diagnosis of ADHD, as measured by the DAWBA
- Participants first language must be Danish
Exclusion Criteria:
- 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
Sites / Locations
- Center for child and adolescent psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
New Forest Parenting Programme
Treatment as Usual
Arm Description
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.
Treatment as usual for preschool ADHD consists of psychoeducation groups for parents.
Outcomes
Primary Outcome Measures
ADHD Rating Scale IV-Preschool Version
A screening instrument for the symptoms of AD/HD in the preschool population.
Secondary Outcome Measures
Preschool ADHD-RS (Teacher completed) 18 items
screening instrument for the symptoms of AD/HD in the preschool population.
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
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
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
Child Health Questionnaire (CHQ-28)
Quality of life measure
Family Strain Index 6 items
Short screening instrument for the detection of family strain
Full Information
NCT ID
NCT01684644
First Posted
September 4, 2012
Last Updated
June 29, 2017
Sponsor
University of Aarhus
Collaborators
Glostrup University Hospital, Copenhagen, TrygFonden, Denmark, Sygekassernes Helsefond
1. Study Identification
Unique Protocol Identification Number
NCT01684644
Brief Title
A Controlled Study of Parent Training in the Treatment of ADHD in Young Children
Acronym
D'SNAPP
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Glostrup University Hospital, Copenhagen, TrygFonden, Denmark, Sygekassernes Helsefond
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Parent Training, RCT, Preschool
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New Forest Parenting Programme
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Other
Arm Description
Treatment as usual for preschool ADHD consists of psychoeducation groups for parents.
Intervention Type
Behavioral
Intervention Name(s)
New Forest Parenting Programme
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
Psychoeducation in groups for parents of young children diagnosed with ADHD
Primary Outcome Measure Information:
Title
ADHD Rating Scale IV-Preschool Version
Description
A screening instrument for the symptoms of AD/HD in the preschool population.
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Secondary Outcome Measure Information:
Title
Preschool ADHD-RS (Teacher completed) 18 items
Description
screening instrument for the symptoms of AD/HD in the preschool population.
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Title
Strength and Difficulties Questionnaire (parent version)
Description
A brief measure of prosocial behaviour and and psychopathology of 3-16 year olds that can be completed by parents
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Title
Strength and Difficulties Questionnaire (teacher completed)
Description
A brief measure of prosocial behaviour and and psychopathology of 3-16 year olds that can be completed by teachers
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Title
Child solo play - observation measure -
Description
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
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Title
Child Health Questionnaire (CHQ-28)
Description
Quality of life measure
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Title
Family Strain Index 6 items
Description
Short screening instrument for the detection of family strain
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Other Pre-specified Outcome Measures:
Title
Parental report on somatic complaints in preschool children
Description
Parental report on somatic complaints in preschool children (Domenech-Llaberia et al., 2004)
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Title
6. The Adult ADHD self-report scale (ASRS-V1.1) 18 items The Adult ADHD self-report scale (ASRS-V1.1) 18 items
Description
Adult ADHD screening instrument
Time Frame
T1 (Baseline)
Title
Parent sense of competence scale (PSOC) (17 items)
Description
Instrument to assess perceived sense of parenting competence
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Title
Maternal expressed emotion - 5 min speech sample.
Description
A 5-min speech sample obtained from mothers, rated over 6 scales with an overall high score indicating a negative influence on the child.
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Title
GIPCI (Jigsaw/Tidy up/Freeplay) observation measure
Description
GIPCI (Jigsaw/Tidy up/Freeplay) observation measure of parent child interaction with global ratings (0-5) for parent and child behaviours
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Title
General Health Questionnaire (12 item)
Description
Screening instrument to detect psychiatric disorders in adults
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Title
Neuropsychological test battery
Description
Working memory (verbal and visuospatial) measured by Word span Forward and Backward as well as using Finger Windows Forward and Backward.
Inhibition measured using a modified four picture pairs Stroop Task as well as the Head-Toes-Knees-Shoulders task.
Flexibility measured using the Switching, Inhibition, and Flexibility Task as well as the Trails-P.
Delay-related behavior measured with the Cookie Delay Task and the Teddy Delay Task
Simple information processing time measured using the Fish task.
In addition, video recordings of the neuropsychological evaluation will be coded and analyzed (private speech and behavior) after the test session
Time Frame
T1 (at baseline), T2 (twelve weeks from T1)
Title
Behavior Rating Inventory of Executive Function - Preschool Version [BRIEF-P]
Time Frame
T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A clinical diagnosis of ADHD, as measured by the DAWBA
Participants first language must be Danish
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Hove Thomsen, MD
Organizational Affiliation
Børne- og Ungdomspsykiatrisk Center-Risskov, Aarhus Universitetshospital, Skovagervej 2, 8240 Risskov, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Center for child and adolescent psychiatry
City
Risskov,
State/Province
Aarhus
ZIP/Postal Code
8240
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
32505701
Citation
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.
Results Reference
derived
PubMed Identifier
30071980
Citation
Lange 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.
Results Reference
derived
PubMed Identifier
27076496
Citation
Lange 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.
Results Reference
derived
Learn more about this trial
A Controlled Study of Parent Training in the Treatment of ADHD in Young Children
We'll reach out to this number within 24 hrs