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

Completed

• Conditions: ADHD
• Interventions: Behavioral: COG - FUN

• Registration Number: NCT01792921
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-27
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Study Start: 2013-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• diagnosis of ADHD
• 7-10 years old
• regular education system
• no moderate or severe neurological and/or psychiatric disorders

Exclusion Criteria

• moderate or severe neurological and/or psychiatric disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control waitlist	COG - FUN	-

Primary Outcome Measures

Name	Time	Method
Change in ADHD parameters	Three assessment points - at recruitment, after 3 months and after 6 months.	Using Brief Questionnaire

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel