- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05950672
Development and Evaluation CAT and Youth (CAT)
The Development and Evaluation of a Novel Cat Assisted Training (CAT) Intervention for Youth With Developmental Disabilities and Their Family Cat
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Corvallis, Oregon, United States, 97331
- Oregon State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child with a developmental disability per parental report.
- Family owns a family cat.
Exclusion Criteria:
- Can not follow instructions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CAT Intervention Group
The experimental group will take part in the CAT intervention (Table 1) after baseline assessments.
All cat-training methods will be positive reinforcement based, using owner-approved food, toys and social reinforcers (e.g.
petting).
|
The experimental group will take part in the CAT intervention after baseline assessments.
All cat-training methods will be positive reinforcement based, using owner-approved food, toys and social reinforcers (e.g.
petting).
|
|
No Intervention: CAT Control Group
Control participants will not participate in the CAT intervention.
After the completion of the third assessment (end of proposal-related data collection), control participants will be offered the opportunity to participate in cat training classes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Whose Cats Changed From Insecure to Secure Attachment Classification From T1 to T3
Time Frame: T3 is approximately 14 months after T1 (baseline).
|
Cats in the intervention group participated in a structured three-phase assessment: two minutes in the testing room with their child owner, two minutes alone, and then a reunion phase when the child returns.
All sessions were video recorded.
Two independent raters classified each cat's attachment style using a predefined behavioral ethogram, with primary emphasis on the cat's response during the reunion.
Possible attachment classifications include Secure, Insecure-Ambivalent, Insecure-Avoidant, Insecure-Disorganized.
Data presented describe within-cat change in attachment classification from T1 to T3, specifically the shift from insecure (inclusive of ambivalent, avoidant, and disorganized) to secure attachment.
|
T3 is approximately 14 months after T1 (baseline).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Participated in Walking Their Cat at T2
Time Frame: T2 is approximately 6 weeks after T1 (baseline).
|
The Cat Care Responsibility Inventory "Walk" variable reflected responses to the item, "Usually walks cat."
Children indicated the household member for whom this statement was most true (e.g., self, mother, father, sibling, or other).
For analysis, responses were coded as a binary variable such that s child either participated in walking the cat (alone or with others in the household) or did not.
These binary outcomes were then compared across time points and participant groups.
|
T2 is approximately 6 weeks after T1 (baseline).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NIH Toolbox Emotional Support (Ages 8-17) Fixed Form: Uncorrected Standard T-score at T2
Time Frame: T2 is approximately 6 weeks after T1 (baseline).
|
Participants completed a 7-item Emotional Support survey from the NIH Toolbox (NIH Toolbox Item Bank v2.0), validated for children ages 8-17. The survey uses a five-point Likert scale (Never, Rarely, Sometimes, Usually, Always) to assess children's experiences of emotional support during the past month. Items ask about perceived access to supportive relationships over the preceding month. Sample question: "I have someone who will listen to me when I need to talk." Scoring Process: Each survey is scored using Item Response Theory (IRT). An IRT-derived theta score is generated for each participant, as is an Uncorrected Standard Score (T-score). Interpretation: For the NIH Toolbox Emotional Support Survey, higher scores are indicative of more emotional support. Scores 1 SD or more below the mean (T ≤ 40) suggest low levels of support, and scores 1 SD or more above the mean (T ≥ 60) suggest high levels of support. T-scores ≤ 40 may warrant heightened surveillance or concern. |
T2 is approximately 6 weeks after T1 (baseline).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HE-2022-29
- 1R21HD109853-01 (U.S. NIH Grant/Contract)
- 5R21HD109853-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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