Conduct DisorderPhase 1/2NCT02093052
Intervening Early With Neglected Children
A Phase 1/2 study testing Attachment and Biobehavioral Catch-up and Developmental Education for Families in people with Conduct Disorder and ADHD, run by University of Delaware at 1 site in United States.
Trial summary
This study will assess early and middle childhood outcomes of an intervention for neglecting parents that was implemented in the children's infancy. We expect that parents who received the Attachment and Biobehavioral Catch-up Intervention in infancy will be more nurturing and will follow children's lead more than… Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Conduct Disorder, ADHD, Depression
- What is being tested?
- Attachment and Biobehavioral Catch-up and Developmental Education for Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Apr 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- must have been in earlier randomized clinical trial
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervening Early With Neglected Children: Key Childhood Outcomes
This study will assess early and middle childhood outcomes of an intervention for neglecting parents that was implemented in the children's infancy. We expect that parents who received the Attachment and Biobehavioral Catch-up Intervention in infancy will be more nurturing and will follow children's lead more than parents who received a control intervention, and that children will show better outcomes in attachment, inhibitory control, emotion regulation, and peer relations than children of parents who received the control intervention.
Read the detailed description
Children were randomly assigned to receive the ABC intervention or a control intervention (DEF) in infancy. These two groups, plus a group of low-risk children, will be studied in early and middle childhood. Of interest will be differences in parent and child outcomes that result from the intervention.
Hypothesis 1: Neglected children whose parents received the ABC intervention and low-risk comparison children will show better inhibitory control than neglected children whose parents received the DEF intervention.
Hypothesis 2: Children in the ABC intervention condition and low-risk comparison children will show better emotion regulation than children in the DEF condition.
Hypothesis 3: Children in the ABC intervention condition and comparison children will show less reactive aggression and less hostile attributional bias than children in the DEF condition.
Hypothesis 4: Children in the ABC condition and comparison children will show more normative cortisol production than children in the DEF condition.
Although we expect that sustained changes in parenting are critical for sustained changes in child behaviors, several alternative models will be tested. First, it is possible that when parents change as a result of the intervention in a child's infancy, there are positive outcomes for children regardless of whether the changes in parenting are sustained. If this is the case, early parenting will mediate the effects of the intervention when controlling for later parenting. Second, if concurrent parenting is what is critical to child functioning, current parenting will mediate intervention effects on child outcomes when controlling for early parenting. Third, longitudinal modeling of both parent and child behaviors allows for analysis of cross-lagged associations using structural equation modeling. Such modeling can examine concurrent and transactional associations between parent and child. We can also examine associations between change at behavioral and biological levels.
Longitudinal modeling will be used to examine models of change in parenting behaviors and how those influence child outcomes.
- Conditions
- Conduct Disorder, ADHD, Depression
- Being tested
- Attachment and Biobehavioral Catch-up, Developmental Education for Families
- Keywords
- Parenting, Parent child relations, Middle childhood outcomes
- Medical subject headings
- Conduct Disorder, Attention Deficit Disorder with Hyperactivity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment and Biobehavioral Catch-upBehavioural
Enhance nurturance and following the lead among parents. In-home intervention with parents and children present.
Developmental Education for FamiliesBehavioural
Enhance children's cognitive development. In-home intervention with parents and children present.
| Study group | Role | What they receive |
|---|---|---|
| Attachment and Biobehavioral Catch-up | Experimental | Attachment and Biobehavioral Catch-up - 10 session intervention to enhance nurturance and following the lead Receives: Behavioral: Attachment and Biobehavioral Catch-up |
| Developmental Education for Families | Active comparator | Developmental Education for Families - 10 session intervention that targets cognitive development Receives: Behavioral: Developmental Education for Families |
| Low-risk | No intervention | Low-risk comparison group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibitory control
DB-DOS- children who successfully do not touch forbidden toys
Measured: Child age of 36 months
Emotion regulation
Children will complete emotion regulation tasks (Perfect Circle and Disappointing Gift)
Measured: Child age of 36 months
Peer relations
Social information processing will be assessed through children's responses to videos of peer provocations.
Measured: Child age of 10 years
Child diagnosis
Parents will complete diagnostic interview.
Measured: Child age of 10
Child aggression
Children will complete video game that will allow assessment of reactive and proactive aggression.
Measured: Child age of 10
Cortisol production
Salivary cortisol levels collected at wake-up and bedtime
Measured: Child age of 24 months
Cortisol production
Salivary cortisol levels collected at wake-up and bedtime
Measured: Child age of 8
Cortisol production
Salivary cortisol levels collected at wake-up and bedtime
Measured: Child age of 10
Attachment
Attachment assessed through Strange Situation
Measured: Age 18 months
Secondary outcomes (16)
Parental sensitivity
Parental sensitivity will be assessed through parent-child interactions.
Measured: Child age of infancy (12-24 months child age)
Child attachment security (narrative measure)
Children's score on Attachment Script Assessment, a narrative technique
Measured: Child age 9
Child inhibitory control in middle childhood
Delay task (Flanker). ERP data will be collected.
Measured: Child age 8
Autonomic nervous system activity
Child heart rate and respiratory sinus arrhythmia
Measured: Child age 8
Child brain activity
Child brain activation assessed in fMRI
Measured: Child age 9
Parent Attachment Script Knowledge
Parents' score on Attachment Script Assessment, a narrative technique
Measured: Child age of 9
Parental sensitivity using Parent-Child Interaction Coding System
Extent to which parent is responsive and attuned in support discussion (coded behaviorally)
Measured: Child age 9
Autonomic nervous system activity
Child Respiratory Sinus Arrhythmia (RSA)
Measured: Child age 10
Alpha and theta wave
Alpha and theta wave activity in resting state EEG
Measured: Child age 9
Round Robin Assessment of Peer Rejection
Play groups of unknown peers constituted and video recorded; videos coded at microanalytic level for indices of peer rejection
Measured: Child age 9
Parent neural activity assessed through event related potentials
Negative 170 ms. (N170: negative deflection 170 ms. after onset of stimulus) in task discriminating infant affect
Measured: Child age 4
Parent neural activity assessed through event related potentials
Late positive potential - 350-600 ms after onset of stimulus (LPP) in task discriminating infant affect
Measured: Child age 4
Child attachment security (self-reported on Kerns' Attachment Inventory)
Self-report from child of extent to which he or she can rely on parent
Measured: Child age 9
Child attachment security (self-reported on Kerns' Attachment Inventory)
Self-report from child of extent to which he or she can rely on parent
Measured: Child age 10
Body mass index
Proportion of height to weight
Measured: Age 3
Body mass index
Proportion of height to weight
Measured: Age 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMar 2005
- Primary completionJan 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Dozier, University of Delaware
- Investigators
- Mary Dozier, Ph.D., Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093052
- Sponsor's protocol ID
- NIH R01 74374
- Status last verified
- Nov 2020
- First submitted
- 18 Mar 2014
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Valadez EA, Tottenham N, Korom M, Tabachnick AR, Pine DS, Dozier M. A Randomized Controlled Trial of a Parenting Intervention During Infancy Alters Amygdala-Prefrontal Circuitry in Middle Childhood. J Am Acad Child Adolesc Psychiatry. 2024 Jan;63(1):29-38. doi: 10.1016/j.jaac.2023.06.015. Epub 2023 Jun 27.
PubMed 37385583Hubbard JA, Bookhout MK, Zajac L, Moore CC, Dozier M. Children's social information processing predicts both their own and peers' conversational remarks. Dev Psychol. 2023 Jun;59(6):1153-1165. doi: 10.1037/dev0001510. Epub 2022 Dec 22.
PubMed 36548042Garnett M, Bernard K, Hoye J, Zajac L, Dozier M. Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial. Psychoneuroendocrinology. 2020 Nov;121:104809. doi: 10.1016/j.psyneuen.2020.104809. Epub 2020 Jul 24.
PubMed 32781397Valadez EA, Tottenham N, Tabachnick AR, Dozier M. Early Parenting Intervention Effects on Brain Responses to Maternal Cues Among High-Risk Children. Am J Psychiatry. 2020 Sep 1;177(9):818-826. doi: 10.1176/appi.ajp.2020.20010011. Epub 2020 Jul 31.
PubMed 32731812Zajac L, Raby KL, Dozier M. Sustained effects on attachment security in middle childhood: results from a randomized clinical trial of the Attachment and Biobehavioral Catch-up (ABC) intervention. J Child Psychol Psychiatry. 2020 Apr;61(4):417-424. doi: 10.1111/jcpp.13146. Epub 2019 Nov 1.
PubMed 31677152Bernard K, Frost A, Jelinek C, Dozier M. Secure attachment predicts lower body mass index in young children with histories of child protective services involvement. Pediatr Obes. 2019 Jul;14(7):e12510. doi: 10.1111/ijpo.12510. Epub 2019 Jan 18.
PubMed 30659782Bernard K, Hostinar CE, Dozier M. Intervention effects on diurnal cortisol rhythms of Child Protective Services-referred infants in early childhood: preschool follow-up results of a randomized clinical trial. JAMA Pediatr. 2015 Feb;169(2):112-9. doi: 10.1001/jamapediatrics.2014.2369.
PubMed 25436448
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening Early With Neglected Children: Key Childhood Outcomes
- ClinicalTrials.gov ID
- NCT02093052
- Acronym / sponsor ID
- NIH R01 74374
- Conditions
- Conduct Disorder, ADHD, Depression
- Keywords
- Parenting, Parent child relations, Middle childhood outcomes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess early and middle childhood outcomes of an intervention for neglecting parents that was implemented in the children's infancy. We expect that parents who received the Attachment and Biobehavioral Catch-up Intervention in infancy will be more nurturing and will follow children's lead more than parents who received a control intervention, and that children will show better outcomes in attachment, inhibitory control, emotion regulation, and peer relations than children of parents who received the control intervention.
Detailed description
Children were randomly assigned to receive the ABC intervention or a control intervention (DEF) in infancy. These two groups, plus a group of low-risk children, will be studied in early and middle childhood. Of interest will be differences in parent and child outcomes that result from the intervention.
Hypothesis 1: Neglected children whose parents received the ABC intervention and low-risk comparison children will show better inhibitory control than neglected children whose parents received the DEF intervention.
Hypothesis 2: Children in the ABC intervention condition and low-risk comparison children will show better emotion regulation than children in the DEF condition.
Hypothesis 3: Children in the ABC intervention condition and comparison children will show less reactive aggression and less hostile attributional bias than children in the DEF condition.
Hypothesis 4: Children in the ABC condition and comparison children will show more normative cortisol production than children in the DEF condition.
Although we expect that sustained changes in parenting are critical for sustained changes in child behaviors, several alternative models will be tested. First, it is possible that when parents change as a result of the intervention in a child's infancy, there are positive outcomes for children regardless of whether the changes in parenting are sustained. If this is the case, early parenting will mediate the effects of the intervention when controlling for later parenting. Second, if concurrent parenting is what is critical to child functioning, current parenting will mediate intervention effects on child outcomes when controlling for early parenting. Third, longitudinal modeling of both parent and child behaviors allows for analysis of cross-lagged associations using structural equation modeling. Such modeling can examine concurrent and transactional associations between parent and child. We can also examine associations between change at behavioral and biological levels.
Longitudinal modeling will be used to examine models of change in parenting behaviors and how those influence child outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Attachment and Biobehavioral Catch-up | Experimental | Behavioral: Attachment and Biobehavioral Catch-upAttachment and Biobehavioral Catch-up - 10 session intervention to enhance nurturance and following the lead |
| Developmental Education for Families | Active comparator | Behavioral: Developmental Education for FamiliesDevelopmental Education for Families - 10 session intervention that targets cognitive development |
| Low-risk | No intervention | –Low-risk comparison group |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- must have been in earlier randomized clinical trial
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attachment and Biobehavioral Catch-upEnhance nurturance and following the lead among parents. In-home intervention with parents and children present. | Behavioural | Attachment and Biobehavioral Catch-up |
| Developmental Education for FamiliesEnhance children's cognitive development. In-home intervention with parents and children present. | Behavioural | Developmental Education for Families |
Primary outcome
Inhibitory control
Time frame: Child age of 36 months
DB-DOS- children who successfully do not touch forbidden toys
Emotion regulation
Time frame: Child age of 36 months
Children will complete emotion regulation tasks (Perfect Circle and Disappointing Gift)
Peer relations
Time frame: Child age of 10 years
Social information processing will be assessed through children's responses to videos of peer provocations.
Child diagnosis
Time frame: Child age of 10
Parents will complete diagnostic interview.
Child aggression
Time frame: Child age of 10
Children will complete video game that will allow assessment of reactive and proactive aggression.
Cortisol production
Time frame: Child age of 24 months
Salivary cortisol levels collected at wake-up and bedtime
Cortisol production
Time frame: Child age of 8
Salivary cortisol levels collected at wake-up and bedtime
Cortisol production
Time frame: Child age of 10
Salivary cortisol levels collected at wake-up and bedtime
Attachment
Time frame: Age 18 months
Attachment assessed through Strange Situation
16 secondary outcomes
Parental sensitivity
Time frame: Child age of infancy (12-24 months child age)
Child attachment security (narrative measure)
Time frame: Child age 9
Child inhibitory control in middle childhood
Time frame: Child age 8
Autonomic nervous system activity
Time frame: Child age 8
Child brain activity
Time frame: Child age 9
Parent Attachment Script Knowledge
Time frame: Child age of 9
Parental sensitivity using Parent-Child Interaction Coding System
Time frame: Child age 9
Autonomic nervous system activity
Time frame: Child age 10
Alpha and theta wave
Time frame: Child age 9
Round Robin Assessment of Peer Rejection
Time frame: Child age 9
Parent neural activity assessed through event related potentials
Time frame: Child age 4
Parent neural activity assessed through event related potentials
Time frame: Child age 4
Child attachment security (self-reported on Kerns' Attachment Inventory)
Time frame: Child age 9
Child attachment security (self-reported on Kerns' Attachment Inventory)
Time frame: Child age 10
Body mass index
Time frame: Age 3
Body mass index
Time frame: Age 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Derived from this study: PubMed 37385583Valadez EA, Tottenham N, Korom M, Tabachnick AR, Pine DS, Dozier M. A Randomized Controlled Trial of a Parenting Intervention During Infancy Alters Amygdala-Prefrontal Circuitry in Middle Childhood. J Am Acad Child Adolesc Psychiatry. 2024 Jan;63(1):29-38. doi: 10.1016/j.jaac.2023.06.015. Epub 2023 Jun 27.
- Derived from this study: PubMed 36548042Hubbard JA, Bookhout MK, Zajac L, Moore CC, Dozier M. Children's social information processing predicts both their own and peers' conversational remarks. Dev Psychol. 2023 Jun;59(6):1153-1165. doi: 10.1037/dev0001510. Epub 2022 Dec 22.
- Derived from this study: PubMed 32781397Garnett M, Bernard K, Hoye J, Zajac L, Dozier M. Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial. Psychoneuroendocrinology. 2020 Nov;121:104809. doi: 10.1016/j.psyneuen.2020.104809. Epub 2020 Jul 24.
- Derived from this study: PubMed 32731812Valadez EA, Tottenham N, Tabachnick AR, Dozier M. Early Parenting Intervention Effects on Brain Responses to Maternal Cues Among High-Risk Children. Am J Psychiatry. 2020 Sep 1;177(9):818-826. doi: 10.1176/appi.ajp.2020.20010011. Epub 2020 Jul 31.
- Derived from this study: PubMed 31677152Zajac L, Raby KL, Dozier M. Sustained effects on attachment security in middle childhood: results from a randomized clinical trial of the Attachment and Biobehavioral Catch-up (ABC) intervention. J Child Psychol Psychiatry. 2020 Apr;61(4):417-424. doi: 10.1111/jcpp.13146. Epub 2019 Nov 1.
- Derived from this study: PubMed 30659782Bernard K, Frost A, Jelinek C, Dozier M. Secure attachment predicts lower body mass index in young children with histories of child protective services involvement. Pediatr Obes. 2019 Jul;14(7):e12510. doi: 10.1111/ijpo.12510. Epub 2019 Jan 18.
- Derived from this study: PubMed 25436448Bernard K, Hostinar CE, Dozier M. Intervention effects on diurnal cortisol rhythms of Child Protective Services-referred infants in early childhood: preschool follow-up results of a randomized clinical trial. JAMA Pediatr. 2015 Feb;169(2):112-9. doi: 10.1001/jamapediatrics.2014.2369.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Dozier, Ph.D. principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Attachment and Biobehavioral Catch-up and Developmental Education for Families in people with Conduct Disorder and ADHD, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibitory control (time frame: Child age of 36 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02093052, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.