Completed

COG FUN Intervention for ADHD

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Behavioral Data

Collected from today forward - Prospective
Behavioral
Who is being recruted

Mental Disorders+1

+ Attention Deficit and Disruptive Behavior Disorders

+ Neurodevelopmental Disorders

From 7 to 10 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Crossover

Comparing exposures during disease occurrence and non-occurrence in order to assess the short-term effects of triggers.
Observational
Study Start: April 2013
See protocol details

Summary

Principal SponsorHadassah Medical Organization
Last updated: February 28, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorHadassah Medical Organization
Last updated: February 28, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

107 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Crossover

In this design, participants serve as their own control. Researchers compare a person's exposures just before a health event with exposures at other times, helping identify short-term triggers or risk factors.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 7 to 10 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersAttention Deficit Disorder with Hyperactivity

Criteria

4 inclusion criteria required to participate
7-10 years old

diagnosis of ADHD

no moderate or severe neurological and/or psychiatric disorders

regular education system

1 exclusion criteria prevent from participating
moderate or severe neurological and/or psychiatric disorders

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hadassah Medical Organization

Jerusalem, IsraelOpen Hadassah Medical Organization in Google Maps
CompletedOne Study Center