Behavior ProblemsPhase 1NCT01261806
Mental Health Services for Toddlers in Foster Care
A Phase 1 study testing Attachment and Biobehavioral Catch-up and Developmental Education for Families in people with Behavior Problems, run by University of Delaware at 1 site in United States.
Trial summary
Toddlers (2- to 3-year-old children) in foster care often have difficulty regulating behavior and biology, and are at risk for a host of mental health problems. Critical issues for toddlers straddle the challenges of infancy and preschool years. Read more about this study
- Who is it for?
- Ages 2 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problems
- 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
- Apr 2010to Dec 2016
- Phase
- Phase 1
- 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 2 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2 -3 years of age, in foster care
Who cannot join
- Not in foster care
Trial locations and contacts
1 site in 1 country.
About this study
Toddlers (2- to 3-year-old children) in foster care often have difficulty regulating behavior and biology, and are at risk for a host of mental health problems. Critical issues for toddlers straddle the challenges of infancy and preschool years. In particular, toddlers in foster care face significant challenges in forming new attachment relationships and developing behavioral and biological regulatory capabilities. This project will assess the effectiveness of an intervention that targets these issues. Attachment and Biobehavioral Catch-up for Toddlers in Foster Care (ABC-T) was developed to help parents: provide nurturing care so that children develop secure, trusting relationships; and supporting children when they become overwhelmed that enhance children's ability to regulate behavior and biology. This intervention's effectiveness will be assessed in a randomized clinical trial.
Read the detailed description
This study assesses the efficacy of a 10-session intervention for young children in the foster care system. Children are randomly assigned to the experimental condition (ABC-T) or to a treatment control (DEF). In the Attachment and Biobehavioral Catch-up for Toddlers (ABC-T) condition, children's foster parents receive an intervention that focuses on nurturance, following children's lead, and helping children settle when they become overwhelmed. In the Developmental Education for Families (DEF) intervention, children's foster parents receive an intervention that focuses on enhancing children's cognitive and motor skills. Both of the interventions are provided in families' homes for 10 sessions of about 60 minutes duration. Outcomes include attachment (assessed in the Preschool Strange Situation), cortisol production (assessed diurnally), child behavior problems (assessed through laboratory procedures that stress children), and through psychiatric interviews.
- Conditions
- Behavior Problems
- Being tested
- Attachment and Biobehavioral Catch-up, Developmental Education for Families
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment and Biobehavioral Catch-upBehavioural
Also called ABC, ABC-T, Attachment and Biobehavioral Catch-up for Foster Toddlers
Enhances nurturance, following the lead, and calming behaviors
Developmental Education for FamiliesBehavioural
Also called DEF, Occupational Therapy/Physical Therapy
Attention control: Enhances parents understanding of developmental milestones
| Study group | Role | What they receive |
|---|---|---|
| Attachment and Biobehavioral Catch-up | Experimental | Attachment and Biobehavioral Catch-up: 10 session intervention in foster families' homes designed to enhance parental nurturance, synchrony, and provide skills such that parents can help children calm down when overwhelmed. Receives: Behavioral: Attachment and Biobehavioral Catch-up |
| Developmental Education for Families | Active comparator | 10 session intervention in foster families' homes that targets cognitive and motor skills of children Receives: Behavioral: Developmental Education for Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
Problem behaviors
Assessed through laboratory measures of child behavior problems. (Disruptive Behavior Diagnostic Observation Schedule)
Measured: Annual
Secondary outcomes (1)
Attachment
Assessed through Preschool Strange Situation
Measured: Once at post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior ProblemsStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, 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
- NCT01261806
- Sponsor's protocol ID
- NIH R01 MH052135
- Status last verified
- Dec 2016
- First submitted
- 14 Dec 2010
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Raby KL, Freedman E, Yarger HA, Lind T, Dozier M. Enhancing the language development of toddlers in foster care by promoting foster parents' sensitivity: Results from a randomized controlled trial. Dev Sci. 2019 Mar;22(2):e12753. doi: 10.1111/desc.12753. Epub 2018 Oct 3.
PubMed 30230658
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Services for Toddlers in Foster Care
- ClinicalTrials.gov ID
- NCT01261806
- Acronym / sponsor ID
- NIH R01 MH052135
- Conditions
- Behavior Problems
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Dec 2010 (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.
Toddlers (2- to 3-year-old children) in foster care often have difficulty regulating behavior and biology, and are at risk for a host of mental health problems. Critical issues for toddlers straddle the challenges of infancy and preschool years. In particular, toddlers in foster care face significant challenges in forming new attachment relationships and developing behavioral and biological regulatory capabilities. This project will assess the effectiveness of an intervention that targets these issues. Attachment and Biobehavioral Catch-up for Toddlers in Foster Care (ABC-T) was developed to help parents: provide nurturing care so that children develop secure, trusting relationships; and supporting children when they become overwhelmed that enhance children's ability to regulate behavior and biology. This intervention's effectiveness will be assessed in a randomized clinical trial.
Detailed description
This study assesses the efficacy of a 10-session intervention for young children in the foster care system. Children are randomly assigned to the experimental condition (ABC-T) or to a treatment control (DEF). In the Attachment and Biobehavioral Catch-up for Toddlers (ABC-T) condition, children's foster parents receive an intervention that focuses on nurturance, following children's lead, and helping children settle when they become overwhelmed. In the Developmental Education for Families (DEF) intervention, children's foster parents receive an intervention that focuses on enhancing children's cognitive and motor skills. Both of the interventions are provided in families' homes for 10 sessions of about 60 minutes duration. Outcomes include attachment (assessed in the Preschool Strange Situation), cortisol production (assessed diurnally), child behavior problems (assessed through laboratory procedures that stress children), and through psychiatric interviews.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attachment and Biobehavioral Catch-up | Experimental | Behavioral: Attachment and Biobehavioral Catch-upAttachment and Biobehavioral Catch-up: 10 session intervention in foster families' homes designed to enhance parental nurturance, synchrony, and provide skills such that parents can help children calm down when overwhelmed. |
| Developmental Education for Families | Active comparator | Behavioral: Developmental Education for Families10 session intervention in foster families' homes that targets cognitive and motor skills of children |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 2 -3 years of age, in foster care
Key exclusion criteria (1 listed)
- Not in foster care
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-upAlso: ABC, ABC-T, Attachment and Biobehavioral Catch-up for Foster ToddlersEnhances nurturance, following the lead, and calming behaviors | Behavioural | Attachment and Biobehavioral Catch-up |
| Developmental Education for FamiliesAlso: DEF, Occupational Therapy/Physical TherapyAttention control: Enhances parents understanding of developmental milestones | Behavioural | Developmental Education for Families |
Primary outcome
Problem behaviors
Time frame: Annual
Assessed through laboratory measures of child behavior problems. (Disruptive Behavior Diagnostic Observation Schedule)
1 secondary outcome
Attachment
Time frame: Once at post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Derived from this study: PubMed 30230658Raby KL, Freedman E, Yarger HA, Lind T, Dozier M. Enhancing the language development of toddlers in foster care by promoting foster parents' sensitivity: Results from a randomized controlled trial. Dev Sci. 2019 Mar;22(2):e12753. doi: 10.1111/desc.12753. Epub 2018 Oct 3.
- Individual participant dataSharing planned: No
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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 study testing Attachment and Biobehavioral Catch-up and Developmental Education for Families in people with Behavior Problems, 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: finished, as of the sponsor's last update on 20 Dec 2016. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Problem behaviors (time frame: Annual). 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 NCT01261806, which also lists 1 linked publication.
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 20 Dec 2016.