Effectiveness of a Cognitive-functional (Cog-Fun) Intervention for Children With ADHD

NCT01792921 | Completed

• 1 other identifier: HMO-0576-12
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Scientific Rationale: Many children with ADHD have serious difficulties in participation in daily occupations in their ecological settings. These difficulties have a pervasive negative impact on their everyday functioning and quality of life (QoL). Although pharmacological treatment has been proven effective in treating ADHD symptoms in many children, as have psychosocial interventions such as parent training, there is little evidence for integrative approaches that address the cognitive, volitional and social-environmental barriers to participation with this population. Although preliminary positive effects of a cognitive-function (Cog-Fun) treatment in occupational therapy on this population have been demonstrated, additional evidence is needed to confirm these initial findings. Methods: Initial results of our pilot study (N=17 children with ADHD) demonstrated significant moderate to large effects of Cog-Fun treatment, which targeted participation and executive functions in daily life. Significant effects were also found for a measure of self-efficacy and neuropsychological measures of attention, planning and organization. Parent ratings showed significant reduction of ADHD symptoms and improved QoL. The purpose of the current study is to replicate the pilot study findings in a randomized controlled trial. The study will be a randomized controlled trial with a crossover design, including 2 groups of children with ADHD attending elementary school and their parents. The research group (Group A, n=50) will receive three months of the Cog-Fun treatment, designed for a parent/child dyad and the control group (Group B, n=50) will be wait-listed and receive treatment after three months. Outcomes will include measures of participation, executive functions in daily life, child and parental self-efficacy, ADHD symptoms and QoL. The investigators expect to find a significant main effect of time (pre-post intervention), group (research vs. control) and a significant interaction effect (group x time) on executive and occupational outcome measures.

Conditions

ADHD

Keywords

Age 7-10 years old; regular education system; no moderate or severe neurological and/or psychiatric disorders

Outcome Measures

Primary Outcomes (1)

• Change in ADHD parameters

  Using Brief Questionnaire

  Three assessment points - at recruitment, after 3 months and after 6 months.

Study Arms (1)

control waitlist

Behavioral: COG - FUN

Interventions

COG - FUN BEHAVIORAL

control waitlist

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children age 7-10 years diagnosed with ADHD

You may qualify if:

• diagnosis of ADHD
• years old
• regular education system
• no moderate or severe neurological and/or psychiatric disorders

You may not qualify if:

• moderate or severe neurological and/or psychiatric disorders

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91240, Israel

Location

Related Publications (1)

• Hahn-Markowitz J, Manor I, Maeir A. Effectiveness of cognitive-functional (Cog-Fun) intervention with children with attention deficit hyperactivity disorder: a pilot study. Am J Occup Ther. 2011 Jul-Aug;65(4):384-92. doi: 10.5014/ajot.2011.000901.

  PMID: 21834453 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neurocognitive Center HMO

Study Record Dates

• First Submitted: January 27, 2013
• First Posted: February 15, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

IL (1)