Non-Accidental Traumatic Head Injury to Child Clinical Trial
Official title:
Longitudinal, Multi-Dimensional Assessment of Recovery and Added Benefit of a Behavioral Health Intervention for Children With Abusive Head Trauma
| Verified date | September 2020 |
| Source | University of Colorado, Denver |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Family dynamics and caregiver responses to a child with traumatic brain injury are implicated both as precipitating events as well as factors influencing outcomes of abusive head trauma (AHT). However, no family behavioral health intervention exists to meet the unique needs of families with infants and very young children with AHT. The study was initially designed as a randomized controlled trial (RCT) to assess the efficacy of an evidence-based behavioral intervention to improve outcomes for families and children with AHT. However, rates of recruitment were so low that the investigators and funder amended the study to be intervention only (with IRB approval). At that time, there were five participants and only one had been assigned to the intervention arm. Only one additional family was recruited, and that family did not complete study measures prior to the time at which the intervention would start and did not receive the intervention. The investigators did examine outcomes in multiple dimensions, including clinical, cognitive, family, caregiver, child behavior, and service usage over time but connot compare to patients not receiving the intervention. The investigators were not able to examine characteristics of patients and families best suited for this behavioral health intervention.
| Status | Completed |
| Enrollment | 7 |
| Est. completion date | June 30, 2020 |
| Est. primary completion date | June 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Months to 2 Years |
| Eligibility |
Inclusion Criteria: - Children who have experienced AHT as determined by the CHCO Child Protection Team - Caregivers who speak English - Families who live in the Denver Metro area and, - Child-victim age between 3 months and 2 years of age Exclusion Criteria: - Those with significant disability that would inhibit participation in the intervention, - Those scoring below 6 months on developmental measures will not be eligible. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Hospital of Colorado | Aurora | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| University of Colorado, Denver |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of cognitive scores of children receiving the ABC intervention to those receiving usual care. | Compare the Cognitive scale standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The cognitive scale standard score ranges from 50-150. Higher scores indicate better cognitive functioning. | 6 months | |
| Primary | Evaluation of motor scores of children receiving the ABC intervention to those receiving usual care. | Compare the overall Motor standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The overall Motor score is a combined score from the Gross Motor and Fine Motor Scales of the Bayley III. The overall motor score is a summed value from the Gross Motor and Fine Motor subscales. Subscale scores are added, then standardized (Mean = 100, SD =15). The range of values for the overall Motor standard score is 50-150. Higher values indicate better motor functioning. | 6 months | |
| Primary | Evaluation of socioemotional scores of children receiving the ABC intervention to those receiving care as usual. | Compare scores from the Social-Emotional standard score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The range of values for the Social-Emotional Scale is 50-150. Higher values indicate better social-emotional functioning. | 6 months | |
| Primary | Evaluation of language scores of children receiving the ABC intervention to those receiving care as usual. | Compare scores on the overall language score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The overall language score is the summed score from the Expressive Language and Receptive Language subscales. The summed value is then standardized (mean = 100, SD = 15). The range of values are 50-150. Higher values indicate better language functioning. | 6 months | |
| Primary | Evaluation of depression scores of caregivers receiving the ABC intervention to those receiving care as usual. | Compare caregiver depression scores of those receiving the intervention to those receiving care as usual. Depression is measured using the Center for Epidemiological Depression Scale (CES-D). Values range from 0-60. Higher values indicate greater depressive symptoms. | 6 months | |
| Primary | Evaluation of anxiety scores of caregivers receiving the ABC intervention to those receiving care as usual. | Compare caregiver scores from the Generalized Anxiety scale (GAD) of those receiving the intervention to those receiving care as usual. The range of values is 0 -21. Higher values indicate greater anxiety symptoms. | 6 months | |
| Primary | Evaluation of parenting stress scores of caregivers receiving the ABC intervention to those receiving care as usual. | Compare scores on the Parenting Stress Index-Short Form of those receiving the intervention to those receiving care as usual. Scores on the PSI-SF are a sum of scores from non-duplicate items from the Parental Distress subscale, Parent-child dysfunctional interaction subscale, and the difficult child subscale. Range of values for the total score are 36-180. Higher values indicate greater parental distress. | 6 months | |
| Primary | Evaluation of family functioning of caregivers receiving the ABC intervention to those receiving care as usual. | Compare scores from the General Functioning subscale of the Family Assessment Device of those receiving the intervention to those receiving care as usual. Scores on the General Functioning subscale range from 12 to 48. Higher values indicate greater family dysfunction. | 6 months | |
| Primary | Evaluation of screener scores of child abuse risk of caregivers receiving the ABC intervention to those receiving care as usual. | Compare scores on the Child Abuse Potential Inventory -Brief Version of caregivers receiving the intervention to those receiving care as usual. Scores on the brief version range from 0-34. Higher scores indicate greater potential risk of child abuse. | 6 months | |
| Primary | Evaluation of caregiver reported service utilization for children receiving the ABC intervention to those receiving care as usual. | Compare the utilization of occupational, physical, speech, vision, feeding, or developmental therapy, as well as receipt of nursing care and family psychological services of those families receiving the intervention compared to those receiving care as usual. Service utilization is captured through a project developed measure asking the respondent if his/her child received any service on the list of services since the last interview period. Any endorsement of any service will be coded affirmative. Indicators of use of those receiving the intervention will be compare to those receiving care as usual. | 6 months | |
| Primary | Evaluation of cognitive scores of children receiving the ABC intervention to those receiving usual care. | Compare the Cognitive scale standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The cognitive scale standard score ranges from 50-150. Higher scores indicate better cognitive functioning. | 9 months | |
| Primary | Evaluation of cognitive scores of children receiving the ABC intervention to those receiving usual care. | Compare the Cognitive scale standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The cognitive scale standard score ranges from 50-150. Higher scores indicate better cognitive functioning. | 12 months | |
| Primary | Evaluation of motor scores of children receiving the ABC intervention to those receiving usual care. | Compare the overall Motor standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The overall Motor score is a combined score from the Gross Motor and Fine Motor Scales of the Bayley III. The overall motor score is a summed value from the Gross Motor and Fine Motor subscales. Subscale scores are added, then standardized (Mean = 100, SD =15). The range of values for the overall Motor standard score is 50-150. Higher values indicate better motor functioning. | 9 months | |
| Primary | Evaluation of motor scores of children receiving the ABC intervention to those receiving usual care. | Compare the overall Motor standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The overall Motor score is a combined score from the Gross Motor and Fine Motor Scales of the Bayley III. The overall motor score is a summed value from the Gross Motor and Fine Motor subscales. Subscale scores are added, then standardized (Mean = 100, SD =15). The range of values for the overall Motor standard score is 50-150. Higher values indicate better motor functioning. | 12 months | |
| Primary | Evaluation of socioemotional scores of children receiving the ABC intervention to those receiving care as usual. | Compare scores from the Social-Emotional standard score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The range of values for the Social-Emotional Scale is 50-150. Higher values indicate better social-emotional functioning. | 9 months | |
| Primary | Evaluation of socioemotional scores of children receiving the ABC intervention to those receiving care as usual. | Compare scores from the Social-Emotional standard score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The range of values for the Social-Emotional Scale is 50-150. Higher values indicate better social-emotional functioning. | 12 months | |
| Primary | Evaluation of language scores of children receiving the ABC intervention to those receiving care as usual. | Compare scores on the overall language score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The overall language score is the summed score from the Expressive Language and Receptive Language subscales. The summed value is then standardized (mean = 100, SD = 15). The range of values are 50-150. Higher values indicate better language functioning. | 9 months | |
| Primary | Evaluation of language scores of children receiving the ABC intervention to those receiving care as usual. | Compare scores on the overall language score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual. The overall language score is the summed score from the Expressive Language and Receptive Language subscales. The summed value is then standardized (mean = 100, SD = 15). The range of values are 50-150. Higher values indicate better language functioning. | 12 months | |
| Primary | Evaluation of depression scores of caregivers receiving the ABC intervention to those receiving care as usual. | Compare caregiver depression scores of those receiving the intervention to those receiving care as usual. Depression is measured using the Center for Epidemiological Depression Scale (CES-D). Values range from 0-60. Higher values indicate greater depressive symptoms. | 9 months | |
| Primary | Evaluation of depression scores of caregivers receiving the ABC intervention to those receiving care as usual. | Compare caregiver depression scores of those receiving the intervention to those receiving care as usual. Depression is measured using the Center for Epidemiological Depression Scale (CES-D). Values range from 0-60. Higher values indicate greater depressive symptoms. | 12 months | |
| Primary | Evaluation of anxiety scores of caregivers receiving the ABC intervention to those receiving care as usual. | Compare caregiver scores from the Generalized Anxiety scale (GAD) of those receiving the intervention to those receiving care as usual. The range of values is 0 -21. Higher values indicate greater anxiety symptoms. | 9 months | |
| Primary | Evaluation of anxiety scores of caregivers receiving the ABC intervention to those receiving care as usual. | Compare caregiver scores from the Generalized Anxiety scale (GAD) of those receiving the intervention to those receiving care as usual. The range of values is 0 -21. Higher values indicate greater anxiety symptoms. | 12 months | |
| Primary | Evaluation of parenting stress scores of caregivers receiving the ABC intervention to those receiving care as usual. | Compare scores on the Parenting Stress Index-Short Form of those receiving the intervention to those receiving care as usual. Scores on the PSI-SF are a sum of scores from non-duplicate items from the Parental Distress subscale, Parent-child dysfunctional interaction subscale, and the difficult child subscale. Range of values for the total score are 36-180. Higher values indicate greater parental distress. | 9 months | |
| Primary | Evaluation of parenting stress scores of caregivers receiving the ABC intervention to those receiving care as usual. | Compare scores on the Parenting Stress Index-Short Form of those receiving the intervention to those receiving care as usual. Scores on the PSI-SF are a sum of scores from non-duplicate items from the Parental Distress subscale, Parent-child dysfunctional interaction subscale, and the difficult child subscale. Range of values for the total score are 36-180. Higher values indicate greater parental distress. | 12 months | |
| Primary | Evaluation of family functioning of caregivers receiving the ABC intervention to those receiving care as usual. | Compare scores from the General Functioning subscale of the Family Assessment Device of those receiving the intervention to those receiving care as usual. Scores on the General Functioning subscale range from 12 to 48. Higher values indicate greater family dysfunction. | 9 months | |
| Primary | Evaluation of family functioning of caregivers receiving the ABC intervention to those receiving care as usual. | Compare scores from the General Functioning subscale of the Family Assessment Device of those receiving the intervention to those receiving care as usual. Scores on the General Functioning subscale range from 12 to 48. Higher values indicate greater family dysfunction. | 12 months | |
| Primary | Evaluation of screener scores of child abuse risk of caregivers receiving the ABC intervention to those receiving care as usual. | Compare scores on the Child Abuse Potential Inventory -Brief Version of caregivers receiving the intervention to those receiving care as usual. Scores on the brief version range from 0-34. Higher scores indicate greater potential risk of child abuse. | 9 months | |
| Primary | Evaluation of screener scores of child abuse risk of caregivers receiving the ABC intervention to those receiving care as usual. | Compare scores on the Child Abuse Potential Inventory -Brief Version of caregivers receiving the intervention to those receiving care as usual. Scores on the brief version range from 0-34. Higher scores indicate greater potential risk of child abuse. | 12 months | |
| Primary | Evaluation of caregiver reported service utilization for children receiving the ABC intervention to those receiving care as usual. | Compare the utilization of occupational, physical, speech, vision, feeding, or developmental therapy, as well as receipt of nursing care and family psychological services of those families receiving the intervention compared to those receiving care as usual. Service utilization is captured through a project developed measure asking the respondent if his/her child received any service on the list of services since the last interview period. Any endorsement of any service will be coded affirmative. Indicators of use of those receiving the intervention will be compare to those receiving care as usual. | 9 months | |
| Primary | Evaluation of caregiver reported service utilization for children receiving the ABC intervention to those receiving care as usual. | Compare the utilization of occupational, physical, speech, vision, feeding, or developmental therapy, as well as receipt of nursing care and family psychological services of those families receiving the intervention compared to those receiving care as usual. Service utilization is captured through a project developed measure asking the respondent if his/her child received any service on the list of services since the last interview period. Any endorsement of any service will be coded affirmative. Indicators of use of those receiving the intervention will be compare to those receiving care as usual. | 12 months | |
| Secondary | Evaluation clusters of patient and family characteristics that benefit most from a parenting intervention component | Compare any changes in Demographic, family, and injury data aggregated in a latent class approach to identify which constellations of risk and protective factors were most amenable to the intervention. | 1 month, 3 month, 6 months, 9 months, 12 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06330831 -
Intensive Group Based CIMT for Young Children
|
N/A |