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A Multi-dimensional Program for Parents of Adolescents With High-functioning Autism

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ClinicalTrials.gov Identifier: NCT03361787
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:

The purpose of this pilot study is to examine the initial efficacy of a multi-dimensional coaching intervention ("Parentship") for parents of adolescents with High Functioning Autism (HFASD).

The "Parentship" protocol is a short-term intervention program in occupational therapy that aims to promote parental resilience and enhance adolescents' participation in daily life.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: "Parentship"- a multi dimensional intervention program to improve parental resilience Not Applicable

Detailed Description:

"Parentship" is a structured occupational therapy intervention for promoting parental resilience and enhance adolescents' participation in daily life The Parentship protocol uses OPC (Graham & Rodger, 2010) as the primary treatment approach. Its primary goal is to lead parents into recognition and understanding of their adolescent's multi-dimensional personal profile that includes sensorimotor, cognitive-behavioral, and social-communicative and personal factors, as required by the International Classification of Functioning (ICF) model (WHO, 2007).

The intervention will be administered by occupational therapists on an individual (or both parents) basis, once a week, over 3-4 months.

10-15 families will be recruited through community advertising. Data will be collected at the onset and completion of the intervention. Data will be analysed using quantitative and qualitative methods.

Adverse events, if occur, will be reported to supervising neurologist and the Helsinki Committee.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of a Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : May 14, 2019
Estimated Study Completion Date : December 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parentship coaching intervention Behavioral: "Parentship"- a multi dimensional intervention program to improve parental resilience
"Parentship" is a multi dimensional intervention program to improve parental resilience and adolescent participation using the OPC model.




Primary Outcome Measures :
  1. Canadian Occupational Performance Measure (COPM) [ Time Frame: 3-4 months ]
    structured interview administered by occupational therapist

  2. Autism: Parenting Questionnaire (APQ) [ Time Frame: 3-4 months ]
    7 dimensions (Knowledge About Autism, Communication, Play, Behaviour Management, Confidence, Stress Management, and Family Functioning) are the focus of this questionnaire that serves as a basis for intervention with parents


Secondary Outcome Measures :
  1. Clinical Assessment of Therapeutic Responses (CATR) [ Time Frame: 1.5 months and 3 months ]
    a questionnaire that monitors the abilities of the therapist to create an optimal parent-therapist relationship



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASD diagnosed by certified medical practitioner
  • parent report regarding barriers to occupational performance/participation
  • SP2 or BRIEF-Parent or SSIS scores reflecting at least 1 SD from typical

Exclusion Criteria:

  • Diagnoses of severe neurological or psychiatric health condition.
  • Instability in pharmacological treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361787


Contacts
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Contact: Tal Mazor-Karsenty, PhD +972.54.6387621 tal.mazor-karse@mail.huji.ac.il
Contact: Adina Maeir, Prof. +972-2-5845307 adina.maeir@mail.huji.ac.il

Locations
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Israel
Hadassah medical organization, Jerusalem Israel Recruiting
Jerusalem, Israel
Contact: Itai Berger, MD    +972-2-584-4751    itberg@hadassah.org.il   
Contact: Hadas Lamberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Hebrew University of Jerusalem

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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03361787     History of Changes
Other Study ID Numbers: 0269-17-HMO-CTIL
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hadassah Medical Organization:
adolescents
parents
coaching

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders