A Controlled Study of Parent Training in the Treatment of ADHD in Young Children

Attention Deficit Hyperactivity Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684644
• Other study ID #: 7-10-1294
• Secondary ID: 7-10-1294
• Status: Completed
• Phase: N/A
• First received: September 4, 2012
• Last updated: June 29, 2017
• Start date: September 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Behavioral:
• New Forest Parenting Programme

• Treatment as usual

Locations

Country	Name	City	State
Denmark	Center for child and adolescent psychiatry	Risskov,	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Glostrup University Hospital, Copenhagen, Sygekassernes Helsefond, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental report on somatic complaints in preschool children	Parental report on somatic complaints in preschool children (Domenech-Llaberia et al., 2004)	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Other	6. The Adult ADHD self-report scale (ASRS-V1.1) 18 items The Adult ADHD self-report scale (ASRS-V1.1) 18 items	Adult ADHD screening instrument	T1 (Baseline)
Other	Parent sense of competence scale (PSOC) (17 items)	Instrument to assess perceived sense of parenting competence	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Other	Maternal expressed emotion - 5 min speech sample.	A 5-min speech sample obtained from mothers, rated over 6 scales with an overall high score indicating a negative influence on the child.	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Other	GIPCI (Jigsaw/Tidy up/Freeplay) observation measure	GIPCI (Jigsaw/Tidy up/Freeplay) observation measure of parent child interaction with global ratings (0-5) for parent and child behaviours	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Other	General Health Questionnaire (12 item)	Screening instrument to detect psychiatric disorders in adults	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Other	Neuropsychological test battery	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	T1 (at baseline), T2 (twelve weeks from T1)
Other	Behavior Rating Inventory of Executive Function - Preschool Version [BRIEF-P]		T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Primary	ADHD Rating Scale IV-Preschool Version	A screening instrument for the symptoms of AD/HD in the preschool population.	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Secondary	Preschool ADHD-RS (Teacher completed) 18 items	screening instrument for the symptoms of AD/HD in the preschool population.	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Secondary	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	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Secondary	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	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Secondary	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	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Secondary	Child Health Questionnaire (CHQ-28)	Quality of life measure	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)
Secondary	Family Strain Index 6 items	Short screening instrument for the detection of family strain	T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)