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

NCT01684644 | Completed

• 1 other identifier: 7-10-1294
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Parent Training; RCT; Preschool

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Preschool ADHD-RS (Teacher completed) 18 items

  T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)

• Strength and Difficulties Questionnaire (parent version)

  T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)

• Strength and Difficulties Questionnaire (teacher completed)

  T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)

• Child solo play - observation measure -

  T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)

• Child Health Questionnaire (CHQ-28)

  T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)

Other Outcomes (8)

• Parental report on somatic complaints in preschool children

  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)

• Parent sense of competence scale (PSOC) (17 items)

  T1 (at baseline), T2 (twelve weeks from T1), T3 (6 months from T1)

Study Arms (2)

New Forest Parenting Programme

EXPERIMENTAL

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

OTHER

Treatment as usual for preschool ADHD consists of psychoeducation groups for parents.

Behavioral: Treatment as usual

Interventions

New Forest Parenting Programme BEHAVIORAL

New Forest Parenting Programme

Treatment as usual BEHAVIORAL

Also known as: Psychoeducation in groups for parents of young children diagnosed with ADHD

Treatment as Usual

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A clinical diagnosis of ADHD, as measured by the DAWBA
• Participants first language must be Danish

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Glostrup University Hospital, Copenhagen: collaborator
• TrygFonden, Denmark: collaborator
• Sygekassernes Helsefond: collaborator

Study Sites (1)

Center for child and adolescent psychiatry

Risskov, Aarhus, 8240, Denmark

Location

Related Publications (3)

• 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.

  PMID: 32505701 DERIVED

• 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.

  PMID: 30071980 DERIVED

• 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.

  PMID: 27076496 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics; Population Groups

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Per Hove Thomsen, MD

  Børne- og Ungdomspsykiatrisk Center-Risskov, Aarhus Universitetshospital, Skovagervej 2, 8240 Risskov, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 13, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

DK (1)