Occupational Performance Coaching in Mothers of Children... | NCT02915926

Studies
Occupational Performance Coaching in Mothers of Children With Cerebral Palsy

NCT02915926

Sponsor

University of Social Welfare and Rehabilitation Science

Status

Completed

Last Update Posted

May 5, 2017Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Cerebral Palsy

Interventions

occupational performance coaching
standard OT

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 26, 2016Actual

Primary Completion Date

Jan 19, 2017Actual

Completion Date

Jan 19, 2017Actual

First Submitted Date

Sep 21, 2016

First Submission Date that Met QC Criteria

Sep 26, 2016

First Posted Date

Sep 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2017

Last Update Posted Date

May 5, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

mina ahmadi kahjoogh, principal investigator, University of Social Welfare and Rehabilitation SciencePrincipal Investigator

Lead Sponsor

University of Social Welfare and Rehabilitation ScienceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A single-blind Randomized Controlled Trial will be used to test the efficacy of the OPC on self-efficacy and occupational performance with mothers of children with cerebral palsy. Canadian Occupational Performance Measurement and Sherer general self-efficacy scale will be employed to data collection. The sample size was determined for each group of 15 people. The participants conveniently and according to inclusion and exclusion criteria will be randomized into the groups. Participants in the intervention group will be participated in 10 sessions of OPC. At the end the questionnaires will be completed by both groups.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OT	Active Comparator	standard OT	Behavioral: standard OT
OT+OPC	Experimental	occupational performance coaching	Behavioral: occupational performance coaching Behavioral: standard OT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
occupational performance coaching	Behavioral		OT+OPC
standard OT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Canadian Occupational Performance Measure	It is a questionnaire.	10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Sherer general self-efficacy	It is a questionnaire.	10 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mothers: being literate 25 to 25 caring nobody disabled other than her child children: 5 to 12 cerebral palsy

Exclusion Criteria:

children: others problems that affect on communication

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Mina Ahmadi Kahjoogh		Tehran		0098	Iran

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided