Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, Parent Training, RCT, Preschool
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.
Interventions
BEHAVIORALNew Forest Parenting Programme
BEHAVIORALTreatment as usual
Sponsors
Glostrup University Hospital, Copenhagen
TrygFonden, Denmark
Sygekassernes Helsefond
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
1. A clinical diagnosis of ADHD, as measured by the DAWBA 2. Participants first language must be Danish
Exclusion criteria
1. Children with intellectual disabilities (i.e. IQ \< 70), Autism Spectrum Disorders. 2. Severe parental psychiatric disorder 3. Severe social adversity, as defined by social services involvement due to suspicions of or detected neglect. 4. Child receiving medication or other treatment for ADHD symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADHD Rating Scale IV-Preschool Version | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Strength and Difficulties Questionnaire (parent version) | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | 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) | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | A brief measure of prosocial behaviour and and psychopathology of 3-16 year olds that can be completed by teachers |
| Preschool ADHD-RS (Teacher completed) 18 items | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | screening instrument for the symptoms of AD/HD in the preschool population. |
| Child Health Questionnaire (CHQ-28) | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | Quality of life measure |
| Family Strain Index 6 items | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | Short screening instrument for the detection of family strain |
| Child solo play - observation measure - | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Parental report on somatic complaints in preschool children | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | Parental report on somatic complaints in preschool children (Domenech-Llaberia et al., 2004) |
| Behavior Rating Inventory of Executive Function - Preschool Version [BRIEF-P] | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | — |
| 6. The Adult ADHD self-report scale (ASRS-V1.1) 18 items The Adult ADHD self-report scale (ASRS-V1.1) 18 items | T1 (Baseline) | Adult ADHD screening instrument |
| Parent sense of competence scale (PSOC) (17 items) | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | Instrument to assess perceived sense of parenting competence |
| Maternal expressed emotion - 5 min speech sample. | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | A 5-min speech sample obtained from mothers, rated over 6 scales with an overall high score indicating a negative influence on the child. |
| GIPCI (Jigsaw/Tidy up/Freeplay) observation measure | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | GIPCI (Jigsaw/Tidy up/Freeplay) observation measure of parent child interaction with global ratings (0-5) for parent and child behaviours |
| General Health Questionnaire (12 item) | T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) | Screening instrument to detect psychiatric disorders in adults |
| Neuropsychological test battery | T1 (at baseline), T2 (twelve weeks from T1) | 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 |
Countries
Denmark
Outcome results
None listed