Trial Outcomes & Findings for The Effectiveness of Participation-focused Interventions on Body Functions of Youth With Physical Disabilities (NCT NCT03851107)

Last Updated: 2021-12-14

Results Overview

The Behavioral Assessment System for Children, Third Edition is a valid and reliable 2-point and 4-point scale for evaluating 18 subscales of global mental and emotional functions. Subscales (e.g. anxiety, attention) include 7 to 13 items. T scores calculated using Pearson's Q-global testing system ranged from 0 to 120, with lower scores indicating higher cognitive and affective functions. Six subscales measuring attention problems, hyperactivity, anxiety, sense of inadequacy, self-esteem, somatization were measured. For each subscale, we plotted the repeated T scores and fitted it into a regression line to represent the average change across the 7 participants. We report the results of the two-level hierarchical models estimating the overall intervention effect size for each of the 6 cognitive and affective outcomes.

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

This outcome will be assessed repeatedly throughout the phases of the study of a period of 22 weeks: baseline (up to 11time-points; up to 11wks) intervention (8 time-points; 8wks) and follow-up (2-points, 4wks). A regression line fitted 22 observations.

Results posted on

2021-12-14

Participant Flow

To reach our sample size, we anticipated that there would be potential withdrawals. Hence, we approached 9 participants.

Participant milestones

Participant milestones
Measure	Community-based Activity Program Engagement in 8-week community-based activity program Engagement in 8-week community-based activity program: Participants engage in a 8-week community-based activity program of their choice. In order to engage in the selected activity, an Occupational Therapist (OT) will meet with each youth in their home. Using the PREP 5 steps (Make goals; Map out a plan; Make it happen; Measure the process and outcomes; Move forward) the youth will choose a community program. The OT will then search for the appropriate program, identify and remove potential environmental barriers for participation in that activity (e.g., accessibility, equipment) and educate program instructors regarding the youth's specific needs. This process, which includes up to 12 hours of working with the OT, will set the stage for enrolment of the youth in a community program for a period of 8 weeks - the actual intervention phase.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Community-based Activity Program n=7 Participants A 22-week individual-based interrupted time series design with multiple baselines was used (Clinical Trials identifier NCT03851107). The time-point in which the intervention, that is engagement in a chosen 8-week activity, was introduced varied. This resulted in different lengths of baselines, of 6 to 11 weeks, across participants.
Age, Continuous	18 years n=7 Participants
Sex: Female, Male Female	3 Participants n=7 Participants
Sex: Female, Male Male	4 Participants n=7 Participants
Region of Enrollment Canada	7 participants n=7 Participants
Functional Issues	3.7 Number of checked items n=7 Participants

PRIMARY outcome

Timeframe: This outcome will be assessed repeatedly throughout the phases of the study of a period of 22 weeks: baseline (up to 11time-points; up to 11wks) intervention (8 time-points; 8wks) and follow-up (2-points, 4wks). A regression line fitted 22 observations.

Outcome measures

Outcome measures
Measure	Change in Behavioural Assessment System for Children n=7 Participants Six subscales from the Behavioral Assessment System for Children (anxiety, attention problems, hyperactivity, self-esteem, somatization, sense of inadequacy) was measured repeatedly (weekly up to 22 weeks) throughout the phases of the study: baseline (up to 11time-points; up to 11 wks) intervention (8 time-points; 8 wks) and follow-up (2-points, 4 wks).
Change in Behavioral Assessment System for Children Anxiety Subscale Baseline	54.73 fixed effects estimate Interval 41.91 to 67.55
Change in Behavioral Assessment System for Children Anxiety Subscale Change at Intervention	-3.35 fixed effects estimate Interval -7.82 to 1.11
Change in Behavioral Assessment System for Children Anxiety Subscale Intervention Trend	-0.05 fixed effects estimate Interval -0.4 to 0.3
Change in Behavioral Assessment System for Children Somatization Subscale Baseline	64.38 fixed effects estimate Interval 41.94 to 86.83
Change in Behavioral Assessment System for Children Somatization Subscale Change at Intervention	0.69 fixed effects estimate Interval -2.68 to 4.07
Change in Behavioral Assessment System for Children Somatization Subscale Intervention trend	-0.01 fixed effects estimate Interval -0.3 to 0.28
Change in Behavioral Assessment System for Children Self-esteem Subscale Baseline	62.89 fixed effects estimate Interval 48.14 to 77.64
Change in Behavioral Assessment System for Children Self-esteem Subscale intervention trend	-0.03 fixed effects estimate Interval -0.27 to 0.21
Change in Behavioral Assessment System for Children Sense of inadequacy Subscale Baseline	56.64 fixed effects estimate Interval 47.18 to 66.11
Change in Behavioral Assessment System for Children Sense of inadequacy Subscale Change at intervention	-1.63 fixed effects estimate Interval -4.55 to 1.29
Change in Behavioral Assessment System for Children Sense of inadequacy Subscale Intervention trend	-0.11 fixed effects estimate Interval -0.5 to 0.28
Change in Behavioral Assessment System for Children Attention problems Subscale Change at intervention	-2.15 fixed effects estimate Interval -5.64 to 1.33
Change in Behavioral Assessment System for Children Hyperactivity Subscale Change at intervention	-4.15 fixed effects estimate Interval -9.94 to 1.63
Change in Behavioral Assessment System for Children Hyperactivity Subscale Intervention trend	-0.49 fixed effects estimate Interval -0.95 to -0.02
Change in Behavioral Assessment System for Children Self-esteem Subscale Change at intervention	-0.83 fixed effects estimate Interval -3.02 to 1.36
Change in Behavioral Assessment System for Children Attention problems Subscale Baseline	47.53 fixed effects estimate Interval 40.27 to 54.8
Change in Behavioral Assessment System for Children Attention problems Subscale Intervention trend	-0.30 fixed effects estimate Interval -0.59 to -0.01
Change in Behavioral Assessment System for Children Hyperactivity Subscale Baseline	56.71 fixed effects estimate Interval 51.77 to 61.64

PRIMARY outcome

Timeframe: This outcome will be assessed biweekly during the study (22 weeks): baseline (up to 6 time-points; up to 11wks) intervention (4 time-points; 8wks) and follow-up (1-point, 4wks). A regression line fitted all motor-related trajectories outcomes.

Measures motor body functions in terms of active/passive range of motion of lower and upper extremities. A score between 0 and 4 is calculated, with 4 being the most severe limitation in range of motion. The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

Outcome measures

Outcome measures
Measure	Change in Behavioural Assessment System for Children n=7 Participants Six subscales from the Behavioral Assessment System for Children (anxiety, attention problems, hyperactivity, self-esteem, somatization, sense of inadequacy) was measured repeatedly (weekly up to 22 weeks) throughout the phases of the study: baseline (up to 11time-points; up to 11 wks) intervention (8 time-points; 8 wks) and follow-up (2-points, 4 wks).
Change in Range of Motion Measure	NA Participants The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

PRIMARY outcome

Assesses trunk control and includes 3 sub-scales; static sitting balance, dynamic sitting balance and coordination. It contains 17 items rated on a 2-, 3- or 4-point scale. Total score Measure motor body functions in terms of trunk control. Total score ranges from 0 (low performance) to 23 (high performance). The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

Outcome measures

Outcome measures
Measure	Change in Behavioural Assessment System for Children n=7 Participants Six subscales from the Behavioral Assessment System for Children (anxiety, attention problems, hyperactivity, self-esteem, somatization, sense of inadequacy) was measured repeatedly (weekly up to 22 weeks) throughout the phases of the study: baseline (up to 11time-points; up to 11 wks) intervention (8 time-points; 8 wks) and follow-up (2-points, 4 wks).
Change in Trunk Impairment Scale	NA Participants The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

PRIMARY outcome

Assesses motor body functions in terms of reaching. The maximum distance in inches the participant can reach forward while standing/sitting in a fixed position is measured: units: inches. The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

Outcome measures

Outcome measures
Measure	Change in Behavioural Assessment System for Children n=7 Participants Six subscales from the Behavioral Assessment System for Children (anxiety, attention problems, hyperactivity, self-esteem, somatization, sense of inadequacy) was measured repeatedly (weekly up to 22 weeks) throughout the phases of the study: baseline (up to 11time-points; up to 11 wks) intervention (8 time-points; 8 wks) and follow-up (2-points, 4 wks).
Change in Functional Reach Test	NA Participants The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

PRIMARY outcome

Measures motor body functions in terns of maximal grip strength; units: pounds of force. Scores range from 0 to 200 pounds. The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

Outcome measures

Outcome measures
Measure	Change in Behavioural Assessment System for Children n=7 Participants Six subscales from the Behavioral Assessment System for Children (anxiety, attention problems, hyperactivity, self-esteem, somatization, sense of inadequacy) was measured repeatedly (weekly up to 22 weeks) throughout the phases of the study: baseline (up to 11time-points; up to 11 wks) intervention (8 time-points; 8 wks) and follow-up (2-points, 4 wks).
Change in Jamar Dynamometer Strength Test	NA Participants The raw motor scores obtained from this assessment was not analyzed separately. Instead, we converted all the motor-related scores to standardized scores to create an index for motor measures. To describe the change observed more accurately we combined the trajectories of all motor scores into a regression line to represent the average change for all motor measures. The results of this analysis are presented in primary outcome 7.

PRIMARY outcome

Timeframe: This outcome will be assessed repeatedly throughout the phases of the study over a period of 18-weeks: baseline (8 time-points; 8 wks) intervention (6 time-points; 6 wks) and follow-up (2-points, 4 wks) resulting in a total of 16 data-points.

Canadian Occupational Performance Measure is a 10-point scale that measures activity performance. Score ranges from 1(unable to perform) to 10 (perform extremely well). A higher score represents higher perceived activity performance levels. A regression line was fitted to represent the average change for the 7 participants for performance (up to 22 observations).

Outcome measures

Outcome measures
Measure	Change in Behavioural Assessment System for Children n=7 Participants Six subscales from the Behavioral Assessment System for Children (anxiety, attention problems, hyperactivity, self-esteem, somatization, sense of inadequacy) was measured repeatedly (weekly up to 22 weeks) throughout the phases of the study: baseline (up to 11time-points; up to 11 wks) intervention (8 time-points; 8 wks) and follow-up (2-points, 4 wks).
Change in Canadian Occupational Performance Measure Canadian Occupational Performance Measure Baseline	2.59 fixed effects estimate Interval 1.83 to 3.36
Change in Canadian Occupational Performance Measure Canadian Occupational Performance Measure Change at Intervention	2.73 fixed effects estimate Interval 0.81 to 4.65
Change in Canadian Occupational Performance Measure Canadian Occupational Performance Measure Intervention trend	-0.49 fixed effects estimate Interval -0.95 to -0.02

PRIMARY outcome

Timeframe: This outcome will be assessed repeatedly throughout the phases of the study: baseline (up to 6 time-points; up to 11 wks) intervention (4 time-points; 8 wks) and follow-up (1-points, 4 wks; ).

Change in motor outcomes was determined by changes in scores (converted to standardized scores according to participant's baseline values) of range of motion (ROM), trunk impairment scale (TIS), functional reach test and Jamar dynamometer strength test (description of each outcome and its scores are presented in outcomes 2-5). We combined all motor-related trajectories outcomes into a regression line to represent the average change for all motor measures. A three-level hierarchical model was ﬁtted, with observations nested within outcomes nested within participants. The results of the combined trajectories are presented (rather than the raw motor scores) as they are more suited to describe the change observed.

Outcome measures

Outcome measures
Measure	Change in Behavioural Assessment System for Children n=6 Participants Six subscales from the Behavioral Assessment System for Children (anxiety, attention problems, hyperactivity, self-esteem, somatization, sense of inadequacy) was measured repeatedly (weekly up to 22 weeks) throughout the phases of the study: baseline (up to 11time-points; up to 11 wks) intervention (8 time-points; 8 wks) and follow-up (2-points, 4 wks).
Change in Motor Outcomes Combined intervention effect	3.71 fixed effects estimate Interval -0.25 to 7.66
Change in Motor Outcomes Change at intervention	1.57 fixed effects estimate Interval -0.69 to 3.83
Change in Motor Outcomes Intervention trend	0.26 fixed effects estimate Interval 0.03 to 0.49

Adverse Events

Community-based Activity Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dana Anaby

McGill University

Phone: 15143984400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place