An interventional study of Attachment and Biobehavioral Catch-up (ABC) in Non-Accidental Traumatic Head Injury to Child, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 3 Months to 2 Years. Per ClinicalTrials.gov, last updated 2020-09-10.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
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Among 95 studies in Craniocerebral Trauma with a site in United States — 12 open to participants now, 17 under way, none of them phase 3. Craniocerebral Trauma · United States.
Among the 95 studies in Craniocerebral Trauma with a site in United States, this one is the 58th largest by enrollment of the 61 interventional ones that give a count, is one of 4 that started in 2018, is one of 50 with no phase, and was the 56th registered.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
Browse Craniocerebral Trauma studies →12 of the 95 studies in Craniocerebral Trauma with a site in United States are open now. Recruiting first, the newest first:
Northern California Institute of Research and Education · Sites in United States
Ages 50–89
Wake Forest University Health Sciences · Sites in United States
Ages up to 18
New York Institute of Technology · Sites in United States
Ages 18–50 · Healthy volunteers
University of California, Davis · Sites in United States
Ages 11–17
VA Office of Research and Development · Sites in United States
Ages 22–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Craniocerebral Trauma studies recruiting now, 8 (32%) set no upper age limit and 14 (56%) stop at 75 or younger; 8 take children under 18; 1 takes healthy volunteers.
This study: 3 Months to 2 Years · all sexes · no healthy volunteers.
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95 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 4 · Phase 3 4 · Phase 4 2
First in 1983; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 7 is below the median of 87 across 133 interventional studies indexed under Craniocerebral Trauma.
Median enrollment 94 across the 61 interventional studies, 192 across the 33 observational. Of the 69 that completed or were terminated, 17 (25%) have results posted.
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9 of 95 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 1 study filed under Craniocerebral Trauma — fewer than ten, so there is no comparison to draw.
3 of the studies in Craniocerebral Trauma with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06632587Thomas Jefferson UniversityTiming Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes | 2026-12-01 |
| NCT06697808Wake Forest University Health SciencesCranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics | 2027-04 |
| NCT05663034Johns Hopkins UniversityCBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms | 2027-06 |
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Among the 95 studies in Craniocerebral Trauma with a site in United States, from their registry updates:
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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.
27 children (ages 3 months to 2 years) and their caregiver referred to the Non-Accidental Brain Injury Care Clinic at the Children's Hospital Colorado (CHCO) were recruited for participation in the study, 7 families consented. One family received the Attachment and Biobehavioral (ABC) intervention. One family discontinued participation. The data collection schedule was 1 month post-injury, 3 months, 6 months, 9 months, and 12 months. Outcomes in multiple dimensions, were assessed including clinical recovery, cognitive, language, and motor functioning, family functioning, caregiver mental health including anxiety, depression, competency, and stress. The investigators also examined service use over time. Analyses will assess trajectories of recovery for both groups using data for all time points.
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Exclusion Criteria:
The investigators will deliver the "Attachment and Biobehavioral Catch-up (ABC)" in the home weekly using live, in-room coaching, to give caregivers feedback as they use targeted skills during interactions with the child. The intervention will last 10 sessions. Study participants in both groups will complete study measures at baseline, 1 month, 3 months, post-intervention, 6 months, and 12 months.
Behavioral: Attachment and Biobehavioral Catch-up (ABC)
Subjects will receive normal standard of care without the "Attachment and Biobehavioral Catch-up (ABC)".
Attachment and Biobehavioral Catch-up (ABC) is an in-home, 10-session, manualized parent-training program for children ages 6 months through 2 years who have experienced early adversity. ABC utilizes parent-child interactions to enhance positive interactions with the child through live coaching with particular focus on nurturing behaviors, following the child's lead, non-frightening behaviors. These behaviors include appropriate soothing and comforting when a child is distressed, responding to or imitating a child in a contingent way, and displaying warmth.
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 9 months
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.
Time frame: 12 months
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.
Time frame: 9 months
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.
Time frame: 12 months
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.
Time frame: 9 months
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.
Time frame: 12 months
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.
Time frame: 9 months
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.
Time frame: 12 months
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.
Time frame: 9 months
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.
Time frame: 12 months
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.
Time frame: 9 months
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.
Time frame: 12 months
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.
Time frame: 9 months
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.
Time frame: 12 months
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.
Time frame: 9 months
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.
Time frame: 12 months
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.
Time frame: 9 months
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.
Time frame: 12 months
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.
Time frame: 9 months
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.
Time frame: 12 months
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.
Time frame: 1 month, 3 month, 6 months, 9 months, 12 months
Plan to share: No
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Ran from Apr 2018 to primary completion in Jun 2020, 26 months.
Of 50 non-industry interventional studies with no phase under Craniocerebral Trauma, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 61. This study's 26 months is close to that.
Counting every sponsor, half of 51 studies reached it within 26 months; a quarter within 11 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →