NCT02093052

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

18.8 years

First QC Date

March 18, 2014

Last Update Submit

November 14, 2020

Conditions

Conduct DisorderADHDDepression

Keywords

ParentingParent child relationsMiddle childhood outcomes

Outcome Measures

Primary Outcomes (9)

  • Inhibitory control

    DB-DOS- children who successfully do not touch forbidden toys

    Child age of 36 months

  • Emotion regulation

    Children will complete emotion regulation tasks (Perfect Circle and Disappointing Gift)

    Child age of 36 months

  • Peer relations

    Social information processing will be assessed through children's responses to videos of peer provocations.

    Child age of 10 years

  • Child diagnosis

    Parents will complete diagnostic interview.

    Child age of 10

  • Child aggression

    Children will complete video game that will allow assessment of reactive and proactive aggression.

    Child age of 10

  • Cortisol production

    Salivary cortisol levels collected at wake-up and bedtime

    Child age of 24 months

  • Cortisol production

    Salivary cortisol levels collected at wake-up and bedtime

    Child age of 8

  • Cortisol production

    Salivary cortisol levels collected at wake-up and bedtime

    Child age of 10

  • Attachment

    Attachment assessed through Strange Situation

    Age 18 months

Secondary Outcomes (16)

  • Parental sensitivity

    Child age of infancy (12-24 months child age)

  • Child attachment security (narrative measure)

    Child age 9

  • Child inhibitory control in middle childhood

    Child age 8

  • Autonomic nervous system activity

    Child age 8

  • Child brain activity

    Child age 9

  • +11 more secondary outcomes

Study Arms (3)

Attachment and Biobehavioral Catch-up

EXPERIMENTAL

Attachment and Biobehavioral Catch-up - 10 session intervention to enhance nurturance and following the lead

Behavioral: Attachment and Biobehavioral Catch-up

Developmental Education for Families

ACTIVE COMPARATOR

Developmental Education for Families - 10 session intervention that targets cognitive development

Behavioral: Developmental Education for Families

Low-risk

NO INTERVENTION

Low-risk comparison group

Interventions

Attachment and Biobehavioral Catch-upBEHAVIORAL

Enhance nurturance and following the lead among parents. In-home intervention with parents and children present.

Attachment and Biobehavioral Catch-up
Developmental Education for FamiliesBEHAVIORAL

Enhance children's cognitive development. In-home intervention with parents and children present.

Developmental Education for Families

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • must have been in earlier randomized clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19711, United States

Location

Related Publications (7)

  • 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.

    PMID: 37385583DERIVED

  • Hubbard 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.

    PMID: 36548042DERIVED

  • Garnett 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.

    PMID: 32781397DERIVED

  • Valadez 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.

    PMID: 32731812DERIVED

  • Zajac 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.

    PMID: 31677152DERIVED

  • Bernard 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.

    PMID: 30659782DERIVED

  • Bernard 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.

    PMID: 25436448DERIVED

MeSH Terms

Conditions

Conduct DisorderAttention Deficit Disorder with HyperactivityDepression

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Mary Dozier, Ph.D.

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 20, 2014

Study Start

March 1, 2005

Primary Completion

January 1, 2024

Study Completion

April 1, 2024

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

US(1)