Clinical trial NCT01684644: A Controlled Study of Parent Training in the Treatment of ADHD in Young Children
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
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Parent Training
RCT
Preschool
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Glostrup University Hospital, Copenhagen
name: TrygFonden, Denmark
name: Sygekassernes Helsefond
First posted: 2012-09-13
Enrollment: 164
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: ADHD Rating Scale IV-Preschool Version
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Secondary outcomes:
measure: Preschool ADHD-RS (Teacher completed) 18 items
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
measure: Strength and Difficulties Questionnaire (parent version)
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
measure: Strength and Difficulties Questionnaire (teacher completed)
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
measure: Child solo play - observation measure -
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
measure: Child Health Questionnaire (CHQ-28)
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
measure: Family Strain Index 6 items
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Other outcomes:
measure: Parental report on somatic complaints in preschool children
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
measure: 6. The Adult ADHD self-report scale (ASRS-V1.1) 18 items The Adult ADHD self-report scale (ASRS-V1.1) 18 items
timeFrame: T1 (Baseline)
measure: Parent sense of competence scale (PSOC) (17 items)
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
measure: Maternal expressed emotion - 5 min speech sample.
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
measure: GIPCI (Jigsaw/Tidy up/Freeplay) observation measure
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
measure: General Health Questionnaire (12 item)
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
measure: Neuropsychological test battery
timeFrame: T1 (at baseline), T2 (twelve weeks from T1)
measure: Behavior Rating Inventory of Executive Function - Preschool Version [BRIEF-P]
timeFrame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Locations:
city: Risskov,
country: Denmark
facility: Center for child and adolescent psychiatry
state: Aarhus
Study officials:
affiliation: Børne- og Ungdomspsykiatrisk Center-Risskov, Aarhus Universitetshospital, Skovagervej 2, 8240 Risskov, Denmark
name: Per Hove Thomsen, MD
role: STUDY_CHAIR
References:
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.
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.
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.