Problem BehaviorsPhase 1NCT00056303
Mental Health Services for Foster and Adopted Children
A Phase 1 study testing Attachment and Biobehavioral Catch-up and Developmental Education for Families in people with Problem Behaviors and Attention Deficit Hyperactivity Disorder, run by University of Delaware at 1 site in United States.
Trial summary
This study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care. Read more about this study
- Who is it for?
- Ages 20 to 36 months
- Conditions the study is for
- Problem Behaviors, Attention Deficit Hyperactivity Disorder, 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
- Dec 2002to 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 20 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Toddler placed into foster care
- Resident of Delaware and surrounding counties in Pennsylvania and Maryland
Who cannot join
- Significant medical problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specialized Mental Health Services for Foster Infants
This study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.
Read the detailed description
Infants and toddlers who are placed into foster or adoptive care often exhibit a number of behavioral, emotional, and physiological problems. In the absence of specialized services, problems in the relationship between caregiver and child may develop; problems in the child's functioning often persist and are exacerbated. This study will attempt to alleviate the attachment and regulatory difficulties that affect many young children placed into care.
Children are randomly assigned to either an experimental group or to a treatment control group for 3 years. The experimental group focuses on relational issues; the control group focuses on cognitive development. Caregivers receiving the relational intervention are trained to provide nurturing care, and to help children learn to develop adequate regulatory skills. Caregivers in the treatment control group receive training designed to enhance children's cognitive development. Caregivers in both groups will receive 10 home visits. Observations of children and parents are used to assess participants.
- Being tested
- Attachment and Biobehavioral Catch-up, Developmental Education for Families
- Keywords
- Attachment, Intervention, Prevention
- Medical subject headings
- Problem Behavior, 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
Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.
Developmental Education for FamiliesBehavioural
Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.
| Study group | Role | What they receive |
|---|---|---|
| Attachment and Biobehavioral Catch-up | Experimental | Attachment and Biobehavioral Catch-up targets nurturance, synchrony, and non-frightening behavior, as well as providing caregivers with help calming toddlers. Receives: Behavioral: Attachment and Biobehavioral Catch-up |
| Developmental Education for Families | Active comparator | Developmental Education for Families targets providing cognitive stimulation to their children. Receives: Behavioral: Developmental Education for Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attachment
The Preschool Strange Situation is conducted annually.
Measured: Annually
Secondary outcomes (2)
Executive Functioning
Disruptive Behaviors-Diagnostic Observation Schedule (DB-DOS) is used to assess problem behaviors. The DB-DOS consists of a series of challenging tasks that ask the child to inhibit prepotent behaviors and regulate emotions.
Measured: Annually
Diurnal production of cortisol
Three days of saliva sampling at wake-up and bedtime.
Measured: Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2003 (estimated)
- Study startDec 2002
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem BehaviorsStudies 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
- Collaborators
- National Institute of Mental Health (NIMH)
- 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
- NCT00056303
- Sponsor's protocol ID
- R01MH052135
- Other IDs
- R01MH052135, DSIR 84-CTCT
- Status last verified
- Dec 2016
- First submitted
- 10 Mar 2003
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
- Specialized Mental Health Services for Foster Infants
- ClinicalTrials.gov ID
- NCT00056303
- Acronym / sponsor ID
- R01MH052135
- Keywords
- Attachment, Intervention, Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2002
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Mar 2003 (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 determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.
Detailed description
Infants and toddlers who are placed into foster or adoptive care often exhibit a number of behavioral, emotional, and physiological problems. In the absence of specialized services, problems in the relationship between caregiver and child may develop; problems in the child's functioning often persist and are exacerbated. This study will attempt to alleviate the attachment and regulatory difficulties that affect many young children placed into care.
Children are randomly assigned to either an experimental group or to a treatment control group for 3 years. The experimental group focuses on relational issues; the control group focuses on cognitive development. Caregivers receiving the relational intervention are trained to provide nurturing care, and to help children learn to develop adequate regulatory skills. Caregivers in the treatment control group receive training designed to enhance children's cognitive development. Caregivers in both groups will receive 10 home visits. Observations of children and parents are used to assess participants.
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 targets nurturance, synchrony, and non-frightening behavior, as well as providing caregivers with help calming toddlers. |
| Developmental Education for Families | Active comparator | Behavioral: Developmental Education for FamiliesDevelopmental Education for Families targets providing cognitive stimulation to their children. |
Who may qualify
- Ages
- 20 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Toddler placed into foster care
- Resident of Delaware and surrounding counties in Pennsylvania and Maryland
Key exclusion criteria (1 listed)
- Significant medical problems
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-upAttachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior. | Behavioural | Attachment and Biobehavioral Catch-up |
| Developmental Education for FamiliesDevelopmental Education for Families is a 10-session in home intervention that targets children's cognitive development. | Behavioural | Developmental Education for Families |
Primary outcome
Attachment
Time frame: Annually
The Preschool Strange Situation is conducted annually.
2 secondary outcomes
Executive Functioning
Time frame: Annually
Diurnal production of cortisol
Time frame: Annually
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.
- 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 Problem Behaviors and Attention Deficit Hyperactivity Disorder, 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 2 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?
Attachment (time frame: Annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.