Autism Spectrum DisorderNCT03361787
A Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
A study testing "Parentship"- a multi dimensional intervention program to improve parental resilience in people with Autism Spectrum Disorder, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- "Parentship"- a multi dimensional intervention program to improve parental resilience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jan 2018to 24 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Diagnoses of severe neurological or psychiatric health condition.
- Instability in pharmacological treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- "Parentship"- a multi dimensional intervention program to improve parental resilience
- Keywords
- adolescents, parents, coaching
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Parentship"- a multi dimensional intervention program to improve parental resilienceBehavioural
"Parentship" is a multi dimensional intervention program to improve parental resilience and adolescent participation using the OPC model.
| Study group | Role | What they receive |
|---|---|---|
| Parentship coaching intervention | Experimental | Not described Receives: Behavioral: "Parentship"- a multi dimensional intervention program to improve parental resilience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
structured interview administered by occupational therapist
Measured: 3-4 months
Autism: Parenting Questionnaire (APQ)
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
Measured: 3-4 months
Secondary outcomes (1)
Clinical Assessment of Therapeutic Responses (CATR)
a questionnaire that monitors the abilities of the therapist to create an optimal parent-therapist relationship
Measured: 1.5 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start15 Jan 2018
- Primary completion15 Aug 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361787
- Sponsor's protocol ID
- 0269-17-HMO-CTIL
- Status last verified
- Sep 2019
- First submitted
- 29 Nov 2017
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
- ClinicalTrials.gov ID
- NCT03361787
- Acronym / sponsor ID
- 0269-17-HMO-CTIL
- Conditions
- Autism Spectrum Disorder
- Keywords
- adolescents, parents, coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parentship coaching intervention | Experimental | Behavioral: "Parentship"- a multi dimensional intervention program to improve parental resilience |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnoses of severe neurological or psychiatric health condition.
- Instability in pharmacological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Behavioural | Parentship coaching intervention |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: 3-4 months
structured interview administered by occupational therapist
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
1 secondary outcome
Clinical Assessment of Therapeutic Responses (CATR)
Time frame: 1.5 months and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Parentship"- a multi dimensional intervention program to improve parental resilience in people with Autism Spectrum Disorder, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: 3-4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.