Trial Outcomes & Findings for The Pediatric Intermed: A New Clinical Decision Making Tool (NCT NCT01781481)

Last Updated: 2016-07-26

Results Overview

34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action). Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains: Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity). Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity). Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity). Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity). Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity).

Recruitment status

COMPLETED

Target enrollment

148 participants

Primary outcome timeframe

Time of Study Participation (Completion of Pediatric INTERMED tool)

Results posted on

2016-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	Children and Youth With IBD Children/youth (ages 8-17) with confirmed diagnoses of Inflammatory Bowel Disease (IBD).
Overall Study STARTED	148
Overall Study COMPLETED	148
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Pediatric Intermed: A New Clinical Decision Making Tool

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Age, Continuous	14.00 years n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants
Region of Enrollment Canada	148 participants n=5 Participants

PRIMARY outcome

Timeframe: Time of Study Participation (Completion of Pediatric INTERMED tool)

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Pediatric INTERMED- Complexity Index Total Complexity Index	24 scores on a scale Interval 8.25 to 39.75	—	—	—	—	—	—
Pediatric INTERMED- Complexity Index Pediatric INTERMED Biological Domain Score	9.0 scores on a scale Interval 6.0 to 12.0	—	—	—	—	—	—
Pediatric INTERMED- Complexity Index Pediatric INTERMED Psychological Domain Score	4.0 scores on a scale Interval 0.0 to 10.0	—	—	—	—	—	—
Pediatric INTERMED- Complexity Index Pediatric INTERMED Social Domain Score	4.0 scores on a scale Interval 0.0 to 9.0	—	—	—	—	—	—
Pediatric INTERMED- Complexity Index Pediatric INTERMED Caregiver/Family Domain Score	4.0 scores on a scale Interval 0.0 to 8.0	—	—	—	—	—	—
Pediatric INTERMED- Complexity Index Pediatric INTERMED Health Service Domain Score	3.0 scores on a scale Interval 1.0 to 5.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Pediatric INTERMED scores at time of study participation

Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological n=148 Participants Sum of Psychological Domain Item Scores	Social n=148 Participants Sum of Social Domain Item Scores	Family/Caregiver n=148 Participants Sum of Family/Caregiver Domain Item Scores	Health Service n=148 Participants Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Correlations Between Pediatric INTERMED Domain Scores Biological	1 Correlation Coefficient	.29 Correlation Coefficient	.34 Correlation Coefficient	.32 Correlation Coefficient	.19 Correlation Coefficient	—	—
Correlations Between Pediatric INTERMED Domain Scores Psychological	.29 Correlation Coefficient	1 Correlation Coefficient	.65 Correlation Coefficient	.64 Correlation Coefficient	.42 Correlation Coefficient	—	—
Correlations Between Pediatric INTERMED Domain Scores Social	.34 Correlation Coefficient	.65 Correlation Coefficient	1 Correlation Coefficient	.63 Correlation Coefficient	.41 Correlation Coefficient	—	—
Correlations Between Pediatric INTERMED Domain Scores Caregiver/Family	.32 Correlation Coefficient	.64 Correlation Coefficient	.63 Correlation Coefficient	1 Correlation Coefficient	.53 Correlation Coefficient	—	—
Correlations Between Pediatric INTERMED Domain Scores Health Service	.19 Correlation Coefficient	.42 Correlation Coefficient	.41 Correlation Coefficient	.53 Correlation Coefficient	1 Correlation Coefficient	—	—

PRIMARY outcome

Timeframe: Day 1 (At time of Pediatric Intermed Interview)

Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological n=148 Participants Sum of Psychological Domain Item Scores	Social n=148 Participants Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Pediatric INTERMED Items Health System: Treatment Experience	51.4 Percentage of participants	43.2 Percentage of participants	5.4 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Biological: Chronicity	.7 Percentage of participants	1.4 Percentage of participants	98 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Biological: Diagnostic Dilemma	.7 Percentage of participants	20.9 Percentage of participants	78.4 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Biological: Symptom Severity	26.4 Percentage of participants	46.6 Percentage of participants	27 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Biological: Diagnostic Challenge	60.8 Percentage of participants	20.9 Percentage of participants	18.2 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Biological: Therapeutic Complexity	2.7 Percentage of participants	6.1 Percentage of participants	91.2 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Biological: Complications and Life Threat	2.7 Percentage of participants	73.6 Percentage of participants	23.7 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Psychological: Barriers to Coping	37.8 Percentage of participants	45.9 Percentage of participants	16.2 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Psychological: Resiliency	43.9 Percentage of participants	43.2 Percentage of participants	12.8 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Psychological: Mental Health History	51.4 Percentage of participants	30.4 Percentage of participants	18.2 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Psychological: Cogntive/Intellectual Development	79.7 Percentage of participants	17.6 Percentage of participants	2.7 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Psychological: Adverse Developmental Events	84.5 Percentage of participants	12.8 Percentage of participants	2.7 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Psychological: Resistance to Treatment	49.3 Percentage of participants	41.9 Percentage of participants	8.8 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Psychological: Mental Health Symptoms	36.5 Percentage of participants	53.4 Percentage of participants	10.2 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Psychological: Cogntive/Functinonal Impairment	96.6 Percentage of participants	2.7 Percentage of participants	.7 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Psychological: Mental Health/Cognitive Threat	31.8 Percentage of participants	58.1 Percentage of participants	10.1 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Social: School Functionning	36.5 Percentage of participants	43.9 Percentage of participants	19.6 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Social: Social Functioning	63.5 Percentage of participants	24.3 Percentage of participants	12.2 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Social: Child/Youth Supports	77.7 Percentage of participants	21.6 Percentage of participants	.7 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Social: School Attendance	55.4 Percentage of participants	25 Percentage of participants	19.6 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Social: Educational NEeds	54.1 Percentage of participants	27.7 Percentage of participants	18.3 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Social: Community Participation	61.5 Percentage of participants	28.4 Percentage of participants	10.2 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Social System Vulnerability	37.8 Percentage of participants	52 Percentage of participants	10.2 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Family: Family Relationships	58.8 Percentage of participants	33.1 Percentage of participants	8.1 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Family: Caregiver Health/Function	45.3 Percentage of participants	43.9 Percentage of participants	10.8 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Family: Residential Stability	60.1 Percentage of participants	33.8 Percentage of participants	6.1 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Family: Caregiver/Family Support	61.5 Percentage of participants	25.7 Percentage of participants	12.8 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Family: Family Stress	14.9 Percentage of participants	66.9 Percentage of participants	18.2 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Family: Parental Skills	62.8 Percentage of participants	34.5 Percentage of participants	2.7 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Family/Caregiver System Vulnerability	39.2 Percentage of participants	55.4 Percentage of participants	5.4 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Health System: Access to Health Care	57.4 Percentage of participants	38.5 Percentage of participants	4.1 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Health System: Organization of Care	2 Percentage of participants	81.1 Percentage of participants	16.9 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Health System: Coordination of Care	70.9 Percentage of participants	25 Percentage of participants	4.1 Percentage of participants	—	—	—	—
Pediatric INTERMED Items Health System Impediments	34.5 Percentage of participants	61.5 Percentage of participants	4.1 Percentage of participants	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Date of patient's participation in the Pediatric Intermed interview).

IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological n=148 Participants Sum of Psychological Domain Item Scores	Social n=148 Participants Sum of Social Domain Item Scores	Family/Caregiver n=148 Participants Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
IBD Disease Severity Disease Severity at Pediatric INTERMED Interview	62.8 percentage of participants	25.7 percentage of participants	8.1 percentage of participants	3.4 percentage of participants	—	—	—
IBD Disease Severity Disease Severity at Diagnosis	4.3 percentage of participants	25.7 percentage of participants	32.1 percentage of participants	37.9 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: Data collected through chart review at time of Pediatric INTERMED interview.

Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in "months since date of diagnosis", with a range from 1 - 131 months.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological n=148 Participants Sum of Psychological Domain Item Scores	Social n=148 Participants Sum of Social Domain Item Scores	Family/Caregiver n=148 Participants Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Time Since IBD Diagnosis	15.5 Percentage of Participants	34.5 Percentage of Participants	32.4 Percentage of Participants	17.6 Percentage of Participants	—	—	—

PRIMARY outcome

Timeframe: Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)

Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Disease Course and Treatment Number of Hospitalizations since Diagnosis	1 number of times it occurred Interval 0.0 to 11.0	—	—	—	—	—	—
Disease Course and Treatment Number of Surgeries Since Diagnosis	0 number of times it occurred Interval 0.0 to 4.0	—	—	—	—	—	—
Disease Course and Treatment Number of Courses of Prednisone	1 number of times it occurred Interval 0.0 to 5.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).

Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2).

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
IBD Treatment With Immunomodulators or Anti-TNFa Medications Use of Immunomodulators	55.4 Percentage of participants treated	—	—	—	—	—	—
IBD Treatment With Immunomodulators or Anti-TNFa Medications Use of anti-TNFa Medications	42.6 Percentage of participants treated	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Functional Disability Inventory: (FDI); Walker \& Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) "no trouble" to "(4) "impossible". The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p\<.001) between the FDI and an objective index of disability (Walker \& Greene, 1991).

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=145 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Functional Disability Inventory FDI - Child Report	4 units on a scale Interval 0.0 to 45.0	—	—	—	—	—	—
Functional Disability Inventory FDI- Parent Report	2 units on a scale Interval 0.0 to 44.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (At time of Pediatric Intermed Interview)

Population: The number of participants was lower due to some missing data for this indicator, due to a few participants not completing this questionnaire.

35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=142 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease. Impact III: Emotional Functioning	45 units on a scale Interval 35.75 to 54.25	—	—	—	—	—	—
Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease. Impact III: Social Interactions	22 units on a scale Interval 18.0 to 26.0	—	—	—	—	—	—
Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease. Impact III: General Well-Being	57 units on a scale Interval 43.5 to 70.5	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Population: The number of participants was lower due to some missing data for this indicator, as a result of a few parents not having completed this questionnaire.

Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=136 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Child Behaviour Checklist CBCL Internalizing	54 Units on a Scale - T Scores Interval 39.0 to 69.0	—	—	—	—	—	—
Child Behaviour Checklist CBCL Externalizing	46 Units on a Scale - T Scores Interval 32.0 to 50.0	—	—	—	—	—	—
Child Behaviour Checklist CBCL Social Competence	45 Units on a Scale - T Scores Interval 34.5 to 55.5	—	—	—	—	—	—
Child Behaviour Checklist CBCL Activities Competence	48 Units on a Scale - T Scores Interval 34.0 to 62.0	—	—	—	—	—	—
Child Behaviour Checklist CBCL Academic Competence	50 Units on a Scale - T Scores Interval 38.5 to 51.5	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Administered at study entry

Population: The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.

27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=143 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Children's Depression Inventory	42 Units on a Scale - T Scores Interval 34.0 to 50.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Population: The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.

Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) "never true about me" to (3) "often true about me". Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=145 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Multidimensional Anxiety Scale for Children	50.00 units on a scale- T scores Interval 36.5 to 63.5	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Population: The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.

Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater "perceived difficulty".

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=133 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Pediatric Inventory for Parents- Difficulty Score	82 units on a scale Interval 42.5 to 121.5	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Population: The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.

Family Inventory of Life Events and Changes (FILE): (McCubbin \& Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=139 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Family Inventory of Life Events and Changes	7 units on a scale Interval 0.0 to 14.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Population: The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.

Family Inventory of Resources for Management (FIRM): (McCubbin \& Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=133 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Family Inventory of Resources for Management Firm: Total Score	127 units on a scale Interval 99.0 to 155.0	—	—	—	—	—	—
Family Inventory of Resources for Management FIRM: Financial Well-being Scale	36 units on a scale Interval 24.5 to 37.5	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis

Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological n=148 Participants Sum of Psychological Domain Item Scores	Social n=148 Participants Sum of Social Domain Item Scores	Family/Caregiver n=148 Participants Sum of Family/Caregiver Domain Item Scores	Health Service n=148 Participants Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity n=148 Participants This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat n=148 Participants This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning Number of Courses of Prednisone since Diagnosis	.10 Correlation Coefficients	.08 Correlation Coefficients	.06 Correlation Coefficients	-.01 Correlation Coefficients	-.10 Correlation Coefficients	.18 Correlation Coefficients	-.07 Correlation Coefficients
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning Impact III: General Well-Being Scale	-.45 Correlation Coefficients	-.05 Correlation Coefficients	.03 Correlation Coefficients	-.65 Correlation Coefficients	-.24 Correlation Coefficients	-.01 Correlation Coefficients	-.17 Correlation Coefficients
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning Number of Surgeries since Diagnosis	.00 Correlation Coefficients	.10 Correlation Coefficients	.15 Correlation Coefficients	.02 Correlation Coefficients	.09 Correlation Coefficients	-.14 Correlation Coefficients	.13 Correlation Coefficients
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning Disease Severity at Diagnosis	-.06 Correlation Coefficients	.06 Correlation Coefficients	-.12 Correlation Coefficients	.09 Correlation Coefficients	-.15 Correlation Coefficients	.04 Correlation Coefficients	-.02 Correlation Coefficients
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning Disease Severity at Study Enrolment	.36 Correlation Coefficients	.01 Correlation Coefficients	-.08 Correlation Coefficients	.53 Correlation Coefficients	.20 Correlation Coefficients	.17 Correlation Coefficients	.18 Correlation Coefficients
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning Functional Disability Index- Child Rating	.50 Correlation Coefficients	.16 Correlation Coefficients	.00 Correlation Coefficients	.56 Correlation Coefficients	.20 Correlation Coefficients	.03 Correlation Coefficients	.23 Correlation Coefficients
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning Functional Disability Index - Parent Rating	.52 Correlation Coefficients	.27 Correlation Coefficients	-.10 Correlation Coefficients	.51 Correlation Coefficients	.14 Correlation Coefficients	.09 Correlation Coefficients	.27 Correlation Coefficients
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning Use of Chemical Immunomodulators since Diagnosis	-.11 Correlation Coefficients	-.18 Correlation Coefficients	-.11 Correlation Coefficients	.16 Correlation Coefficients	.07 Correlation Coefficients	-.42 Correlation Coefficients	-.20 Correlation Coefficients
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning Use of Biological Immunodulators Since Diagnosis	-.09 Correlation Coefficients	.13 Correlation Coefficients	-.04 Correlation Coefficients	-.09 Correlation Coefficients	.12 Correlation Coefficients	-.32 Correlation Coefficients	-.06 Correlation Coefficients

PRIMARY outcome

Timeframe: Day 1 (Time of Study Participation)

Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=133 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological n=133 Participants Sum of Psychological Domain Item Scores	Social n=133 Participants Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. CBCL Internalizing Score	.56 Pearson Correlation Coefficient	.46 Pearson Correlation Coefficient	.46 Pearson Correlation Coefficient	—	—	—	—
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. CBCL Externalizing Score	.52 Pearson Correlation Coefficient	.42 Pearson Correlation Coefficient	.38 Pearson Correlation Coefficient	—	—	—	—
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. Children's Depression Inventory	.41 Pearson Correlation Coefficient	.46 Pearson Correlation Coefficient	.38 Pearson Correlation Coefficient	—	—	—	—
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. Multidimensional Anxiety Scale for Children	.24 Pearson Correlation Coefficient	.19 Pearson Correlation Coefficient	.14 Pearson Correlation Coefficient	—	—	—	—
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. Impact III: Emotional Functioning	-.35 Pearson Correlation Coefficient	-.30 Pearson Correlation Coefficient	-.33 Pearson Correlation Coefficient	—	—	—	—
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. CBCL Social Competence	-.32 Pearson Correlation Coefficient	-.38 Pearson Correlation Coefficient	-.29 Pearson Correlation Coefficient	—	—	—	—
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. CBCL Activities Competence	-.18 Pearson Correlation Coefficient	-.23 Pearson Correlation Coefficient	-.27 Pearson Correlation Coefficient	—	—	—	—
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. CBCL Academic Competence	-.50 Pearson Correlation Coefficient	-.59 Pearson Correlation Coefficient	-.35 Pearson Correlation Coefficient	—	—	—	—
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. Impact III: Social Interactions	.40 Pearson Correlation Coefficient	-.38 Pearson Correlation Coefficient	-.37 Pearson Correlation Coefficient	—	—	—	—
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. PIP Difficulty Score	.22 Pearson Correlation Coefficient	.41 Pearson Correlation Coefficient	.39 Pearson Correlation Coefficient	—	—	—	—
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. Family Inventory of Life Events	.31 Pearson Correlation Coefficient	.36 Pearson Correlation Coefficient	.41 Pearson Correlation Coefficient	—	—	—	—
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. Family Inventory of Resources for Management	-.26 Pearson Correlation Coefficient	-.28 Pearson Correlation Coefficient	-.46 Pearson Correlation Coefficient	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (At time of Pediatric Intermed Interview)

Population: The number of participants was lower due to some missing data for the MASC measure, due to fewer participants completing this questionnaire.

This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=145 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological n=145 Participants Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range. Mental Health/Cognitive Vulnerability Need	4 participants	10 participants	—	—	—	—	—
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range. No Mental Health/Cognitive Vulnerability	6 participants	125 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (At time of Pediatric Intermed Interview)

Population: The number of participants was lower due to some missing data for the CDI measure, due to fewer participants completing this questionnaire.

This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=143 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological n=143 Participants Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range. Mental Health/Cognitive Vulnerability Need	3 participants	11 participants	—	—	—	—	—
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range. No Mental Health/Cognitive Vulnerability	4 participants	125 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (At time of Pediatric Intermed Interview)

Population: The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.

This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=135 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological n=135 Participants Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range. Mental Health/Cognitive Vulnerability Need	8 participants	5 participants	—	—	—	—	—
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range. No Mental Health/Cognitive Vulnerability	22 participants	100 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (At time of Pediatric Intermed Interview)

Population: The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.

This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=135 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological n=135 Participants Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range. Mental Health/Cognitive Vulnerability Need	5 participants	8 participants	—	—	—	—	—
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range. No Mental Health/Cognitive Vulnerability	3 participants	119 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis

Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological n=148 Participants Sum of Psychological Domain Item Scores	Social n=148 Participants Sum of Social Domain Item Scores	Family/Caregiver n=148 Participants Sum of Family/Caregiver Domain Item Scores	Health Service n=148 Participants Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity n=148 Participants This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators FIRM: Financial Well Being Scale	-.32 Correlation Coefficients	-.34 Correlation Coefficients	-.13 Correlation Coefficients	-.03 Correlation Coefficients	-.15 Correlation Coefficients	-.36 Correlation Coefficients	—
Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators Number of Services involved in Child's Care	.26 Correlation Coefficients	.08 Correlation Coefficients	.25 Correlation Coefficients	.37 Correlation Coefficients	.20 Correlation Coefficients	.15 Correlation Coefficients	—
Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators Number of Hospitalizations since Diagnosis	.34 Correlation Coefficients	.36 Correlation Coefficients	.14 Correlation Coefficients	.11 Correlation Coefficients	.09 Correlation Coefficients	.23 Correlation Coefficients	—
Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators Numbers of Surgeries since Hospitalization	.22 Correlation Coefficients	.25 Correlation Coefficients	.10 Correlation Coefficients	.08 Correlation Coefficients	.13 Correlation Coefficients	.11 Correlation Coefficients	—

PRIMARY outcome

Timeframe: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)

Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Total Number of Hospital Services Involved in Child's Care.	2.00 R Square change statistic Interval 0.0 to 5.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)

Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Number of Calls to IBD Nurse	0 Number of calls Interval 0.0 to 15.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)

Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Number of Extra Appointments With the IBD Team	0 Number of appointments Interval 0.0 to 4.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)

Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Number of Visits to the Hospital Emergency Department	0 Emergency Department Visits Interval 0.0 to 5.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)

Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.

Outcome measures

Outcome measures
Measure	Children and Youth With IBD n=148 Participants Children/youth (ages 8-17) with confirmed diagnoses of IBD.	Psychological Sum of Psychological Domain Item Scores	Social Sum of Social Domain Item Scores	Family/Caregiver Sum of Family/Caregiver Domain Item Scores	Health Service Sum of Health Service Domain Item Scores	Current Biological Item: Therapeutic Complexity This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	Vulnerability Biological Item: Complications and Life Threat This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Number of Inpatient Hospital Admissions	0 Number of hospital admissions Interval 0.0 to 3.0	—	—	—	—	—	—

Adverse Events

Children and Youth With IBD

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. Janice Cohen

Children's HOspital of Eastern Ontario

Phone: 613-737-7600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place