Behavior ProblemNCT04048720
Norwalk Feasibility Study
A study testing Family Nurture Intervention in people with Behavior Problem and Development Delay, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is two-fold: 1) to examine the feasibility of the Drop-In model of Family Nurture Intervention (FNI); and 2) to collect pilot data concerning the mother's response to the Drop-In model of FNI and short term effects of participation. Read more about this study
- Who is it for?
- Ages 24 to 78 monthsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problem, Development Delay, Emotional Disturbances
- What is being tested?
- Family Nurture Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 1 Oct 2019
- Phase
- Interventional
- 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 24 to 78 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother is fluent in English or Spanish
- Mother is 18 years of age or older at the time of consent
- Mother-child pair does not demonstrate emotional connection as measured by the WECS
- Child is between the ages of 2 to 4½ years at date of enrollment (child must be younger than 4 years and 9 months at baseline assessment) or between 2 to 4½ at date of enrollment in study AAAQ9547
- Child resides with mother
Who cannot join
- The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy
- The child has a diagnosis of Autism Spectrum Disorder
- The child has severe motor or physical disability
- Mother currently presents with psychosis or is currently taking antipsychotic medication
- Current maternal drug and/or alcohol abuse
- Mother is more than four months pregnant
- Mother and/or infant has a medical condition or contagion that precludes intervention components
- Mother is unable to commit to study schedule
Trial locations and contacts
1 site in 1 country.
United States1 site
Norwalk Housing Authority
Norwalk, Connecticut, 06854
About this study
Official title: Norwalk Drop-In Family Nurture Intervention
The purpose of this study is two-fold: 1) to examine the feasibility of the Drop-In model of Family Nurture Intervention (FNI); and 2) to collect pilot data concerning the mother's response to the Drop-In model of FNI and short term effects of participation. Feasibility of the Program will be measured through costs, staffing, space availability, and uptake. Participation in the Drop-In entails weekly visits for FNI. The investigators hypothesize that the Family Nurture Intervention will show feasibility through attendance and positive response to the Drop-In format. The investigators also expect the Family Nurture Intervention to improve mother's perceived well-being and mother-child emotional connection.
Read the detailed description
Family Nurture Intervention (FNI) is a novel family-based program that facilitates mother-child emotional connection and co-regulation. Many current interventions aim at helping the child to self-regulate with or without the mother's help. However, the ability of the mother-child dyad to promote optimal development is dependent on their ability to co-regulate. The interactive co-regulation between the mother and the child shapes the behavior of both the mother and the child.
This study aims to investigate the feasibility and short term effects of participation in the Family Nurture Intervention for preschool aged children with developmental and behavior problems. Mothers and children will be engaged by Nurture Specialists in comforting and calming interactions to co-regulate with each other during weekly group sessions with the support of study staff. Intervention sessions will occur over the course of eight weeks, and each mother will decide how many sessions to attend.
- Conditions
- Behavior Problem, Development Delay, Emotional Disturbances, Family Conflict, Relation, Mother-Child
- Being tested
- Family Nurture Intervention
- Keywords
- Family Nurture Intervention, Martha G. Welch MD, Feasibility Study, Preschool intervention, Co-regulation, Emotional Connection, Multiple Family Group Intervention
- Medical subject headings
- Mental Disorders, Learning Disabilities, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Nurture InterventionBehavioural
Also called FNI
The mother-child pair will be asked to talk and play with each other as the pair customarily does. If the child becomes restless and dysregulated, the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comforting touch, soothing words and eye contact. Each dyad will be offered eight group FNI sessions.
| Study group | Role | What they receive |
|---|---|---|
| Family Nurture Intervention (FNI) | Experimental | FNI sessions will be held once a week in the afternoon for eight weeks. Participants will take part in FNI group therapy with their child alongside other mother-child pairs. One to two staff members will lead FNI sessions. Receives: Behavioral: Family Nurture Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-child session interest
Study staff will track interest level and engagement with FNI through weekly forms and notes; mothers will be asked to give feedback on their experience of the study at the completion of eight weeks.
Measured: 8 weeks
Change in videotaped Welch Lap Test
Mother-child 5-minute videotaped interactions, recorded weekly after each session, will be assessed for social engagement and emotional connection via the Welch Emotional Connection Screen (WECS).
The Welch Emotional Connection Scale (WECS) construct is emotional connection between mother and child, which the investigators hypothesize predicts optimal development. There are four items on the WECS: Mutual Attraction, Mutual Vocal Exchange, Mutual Facial Engagement, and Mutual Sensitivity/Reciprocity. Each item is rated on a scale from 1 to 3 in 0.25 increments with a score of 3 considered optimal. There is also a binary question to the rater asking if the pair is emotionally connected - yes or no. The mother and child are scored as a pair, not individually.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start5 Jul 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior ProblemStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Norwalk Housing Authority (NHA)
- Responsible party
- Sponsor
- Investigators
- Martha Welch, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048720
- Sponsor's protocol ID
- AAAS0112
- Status last verified
- Nov 2020
- First submitted
- 6 Aug 2019
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwalk Drop-In Family Nurture Intervention
- ClinicalTrials.gov ID
- NCT04048720
- Acronym / sponsor ID
- AAAS0112
- Conditions
- Behavior Problem, Development Delay, Emotional Disturbances, Family Conflict, Relation, Mother-Child
- Keywords
- Family Nurture Intervention, Martha G. Welch MD, Feasibility Study, Preschool intervention, Co-regulation, Emotional Connection, Multiple Family Group Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Norwalk Housing Authority (NHA)
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 7 Aug 2019 (actual)
- 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.
The purpose of this study is two-fold: 1) to examine the feasibility of the Drop-In model of Family Nurture Intervention (FNI); and 2) to collect pilot data concerning the mother's response to the Drop-In model of FNI and short term effects of participation. Feasibility of the Program will be measured through costs, staffing, space availability, and uptake. Participation in the Drop-In entails weekly visits for FNI. The investigators hypothesize that the Family Nurture Intervention will show feasibility through attendance and positive response to the Drop-In format. The investigators also expect the Family Nurture Intervention to improve mother's perceived well-being and mother-child emotional connection.
Detailed description
Family Nurture Intervention (FNI) is a novel family-based program that facilitates mother-child emotional connection and co-regulation. Many current interventions aim at helping the child to self-regulate with or without the mother's help. However, the ability of the mother-child dyad to promote optimal development is dependent on their ability to co-regulate. The interactive co-regulation between the mother and the child shapes the behavior of both the mother and the child.
This study aims to investigate the feasibility and short term effects of participation in the Family Nurture Intervention for preschool aged children with developmental and behavior problems. Mothers and children will be engaged by Nurture Specialists in comforting and calming interactions to co-regulate with each other during weekly group sessions with the support of study staff. Intervention sessions will occur over the course of eight weeks, and each mother will decide how many sessions to attend.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family Nurture Intervention (FNI) | Experimental | Behavioral: Family Nurture InterventionFNI sessions will be held once a week in the afternoon for eight weeks. Participants will take part in FNI group therapy with their child alongside other mother-child pairs. One to two staff members will lead FNI sessions. |
Who may qualify
- Ages
- 24 to 78 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Mother is fluent in English or Spanish
- Mother is 18 years of age or older at the time of consent
- Mother-child pair does not demonstrate emotional connection as measured by the WECS
- Child is between the ages of 2 to 4½ years at date of enrollment (child must be younger than 4 years and 9 months at baseline assessment) or between 2 to 4½ at date of enrollment in study AAAQ9547
- Child resides with mother
Key exclusion criteria (8 listed)
- The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy
- The child has a diagnosis of Autism Spectrum Disorder
- The child has severe motor or physical disability
- Mother currently presents with psychosis or is currently taking antipsychotic medication
- Current maternal drug and/or alcohol abuse
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 |
|---|---|---|
| Family Nurture InterventionAlso: FNIThe mother-child pair will be asked to talk and play with each other as the pair customarily does. If the child becomes restless and dysregulated, the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comforting touch, soothing words and eye contact. Each dyad will be offered eight group FNI sessions. | Behavioural | Family Nurture Intervention (FNI) |
Primary outcome
Mother-child session interest
Time frame: 8 weeks
Study staff will track interest level and engagement with FNI through weekly forms and notes; mothers will be asked to give feedback on their experience of the study at the completion of eight weeks.
Change in videotaped Welch Lap Test
Time frame: 8 weeks
Mother-child 5-minute videotaped interactions, recorded weekly after each session, will be assessed for social engagement and emotional connection via the Welch Emotional Connection Screen (WECS). The Welch Emotional Connection Scale (WECS) construct is emotional connection between mother and child, which the investigators hypothesize predicts optimal development. There are four items on the WECS: Mutual Attraction, Mutual Vocal Exchange, Mutual Facial Engagement, and Mutual Sensitivity/Reciprocity. Each item is rated on a scale from 1 to 3 in 0.25 increments with a score of 3 considered optimal. There is also a binary question to the rater asking if the pair is emotionally connected - yes or no. The mother and child are scored as a pair, not individually.
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 9 Nov 2020.
Related trials for Behavior Problem
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Recruiting
Online Feeding Education for Fathers of Children With Feeding Problems
Feeding Problems, Parent Training
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
Not yet recruiting
Hybrid Pilot of Personalized Parent-Child Interaction Therapy
Disruptive Behaviors
Not yet recruiting
Self-Concept Reinforcement for Early School Readiness
Child Behavior, Child Behavior Problem
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.
Martha Welch, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Nurture Intervention in people with Behavior Problem and Development Delay, run by Columbia University 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 5 inclusion and 8 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 9 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.
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?
Mother-child session interest (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 9 Nov 2020.