A Controlled Study of Parent Training in the Treatment of ADHD in Young Children (D'SNAPP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Aarhus
Sponsor:
Collaborators:
Glostrup University Hospital, Copenhagen
TrygFonden, Denmark
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01684644
First received: September 4, 2012
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder
Behavioral: New Forest Parenting Programme
Behavioral: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • ADHD Rating Scale IV-Preschool Version [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    A screening instrument for the symptoms of AD/HD in the preschool population.


Secondary Outcome Measures:
  • Preschool ADHD-RS (Teacher completed) 18 items [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    screening instrument for the symptoms of AD/HD in the preschool population.

  • Strength and Difficulties Questionnaire (parent version) [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    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) [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    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 - [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    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) [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    Quality of life measure

  • Family Strain Index 6 items [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    Short screening instrument for the detection of family strain


Other Outcome Measures:
  • Parental report on somatic complaints in preschool children [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    Parental report on somatic complaints in preschool children (Domenech-Llaberia et al., 2004)

  • 6. The Adult ADHD self-report scale (ASRS-V1.1) 18 items The Adult ADHD self-report scale (ASRS-V1.1) 18 items [ Time Frame: T1 (Baseline) ] [ Designated as safety issue: No ]
    Adult ADHD screening instrument

  • Parent sense of competence scale (PSOC) (17 items) [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    Instrument to assess perceived sense of parenting competence

  • Maternal expressed emotion - 5 min speech sample. [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    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 [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    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) [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1) ] [ Designated as safety issue: No ]
    Screening instrument to detect psychiatric disorders in adults

  • Neuropsychological test battery [ Time Frame: T1 (at baseline), T2 (twelve weeks from T1) ] [ Designated as safety issue: No ]

    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


  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New Forest Parenting Programme
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.
Behavioral: New Forest Parenting Programme
Treatment as Usual
Treatment as usual for preschool ADHD consists of psychoeducation groups for parents.
Behavioral: Treatment as usual
Other Name: Psychoeducation in groups for parents of young children diagnosed with ADHD

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

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 80), Autism Spectrum Disorders, severe auditory or visual sensory disorder.
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684644

Contacts
Contact: Anne-Mette Lange, MSc ClinPsych 0045 28771566 annelang@rm.dk
Contact: Per Hove Thomsen, MD perhth@rm.dk

Locations
Denmark
Center for child and adolescent psychiatry Recruiting
Risskov,, Aarhus, Denmark, 8240
Contact: Anne-Mette Lange, MSc Clinical Psychology    004528771566    annelang@rm.dk   
Principal Investigator: Anne-Mette Lange, MScClinical Pschology         
Sponsors and Collaborators
University of Aarhus
Glostrup University Hospital, Copenhagen
TrygFonden, Denmark
Investigators
Study Chair: Per Hove Thomsen, MD Børne- og Ungdomspsykiatrisk Center-Risskov, Aarhus Universitetshospital, Skovagervej 2, 8240 Risskov, Denmark
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01684644     History of Changes
Other Study ID Numbers: 7-10-1294, 7-10-1294
Study First Received: September 4, 2012
Last Updated: September 12, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
ADHD
Parent Training
RCT
Preschool

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014