NCT02915926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

September 21, 2016

Last Update Submit

May 2, 2017

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Canadian Occupational Performance Measure

    It is a questionnaire.

    10 weeks

Secondary Outcomes (1)

  • Sherer general self-efficacy

    10 weeks

Study Arms (2)

OT

ACTIVE COMPARATOR

standard OT

Behavioral: standard OT

OT+OPC

EXPERIMENTAL

occupational performance coaching

Behavioral: occupational performance coachingBehavioral: standard OT

Interventions

occupational performance coachingBEHAVIORAL
OT+OPC
standard OTBEHAVIORAL
OTOT+OPC

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • children: others problems that affect on communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mina Ahmadi Kahjoogh

Tehran, 0098, Iran

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 27, 2016

Study Start

July 26, 2016

Primary Completion

January 19, 2017

Study Completion

January 19, 2017

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

IR(1)