Behavior ProblemNCT03442439
Stamford Group Family Nurture Intervention
A study testing Nutrition and Play Intervention and Family Nurture Intervention in people with Behavior Problem and Developmental Delay, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional… Read more about this study
- Who is it for?
- Ages 24 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problem, Developmental Delay, Emotional Disturbances
- What is being tested?
- Nutrition and Play Intervention and Family Nurture Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 25 Nov 2018
- 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 54 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is a singleton
- Mother can speak, read and write in English or Spanish
- Child is between the ages of 2-4 1/2 years at date of enrollment
- Mother is 18 years of age or older at the time of consent
- Child resides with mother
- Child demonstrates developmental deficit as measured by the Strengths and Difficulties Questionnaire (13 or higher on behavioral questions or 4 or less on prosocial questions)
- Mother and child deemed "emotionally unconnected" using the Welch Emotional Connection Scale (WECS) to score their five minute Welch Lap Test video
- Mother is able to commit to study schedule
Who cannot join
- The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral palsy
- Child has a motor disability
- Mother sees or hears things that other people do not seem to see or hear
- Mother has trouble distinguishing whether something is real or part of imagination or dreams
- Mother is currently taking antipsychotic medications
- Mother or child have any medical conditions that might prevent them from participating in block play, mother holding child, or child sitting on mother's lap
Show all 10Show fewer
- Mother has any current drug and/or alcohol abuse
- Mother is more than 4 months pregnant
- Mother is currently involved with Department of Children and Families
- The child has a diagnosis of Autism
Trial locations and contacts
1 site in 1 country.
United States1 site
Stamford Childrens Learning Center
Stamford, Connecticut, 06902
About this study
The purpose of this current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral, and developmental disorders. The investigator hypothesizes that the children who are treated with Family Nurture Intervention (FNI), which incorporates interactive touch with vocal soothing, and family practice in comforting, will show increased emotional connection and mother child co-regulation with better results in the outcome measures in the short term and long term.
Read the detailed description
There are several early intervention programs that are available for children with emotional, behavioral and developmental disorders, ranging from behavioral treatment and sensory exposure therapy to pharmaceutical treatments. Although improvements in behavior have resulted from these interventions, they are limited in numerous ways. They are usually time-consuming, both for the child and the teacher or clinician providing the intervention. In order to see an effect of the intervention, most children must engage in the intervention procedure for several years. Moreover, the effects of most current intervention procedures are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable side effects that may modulate behavior, emotion, and physiological functions. The behavioral, neurobiological, and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders.
- Being tested
- Nutrition and Play Intervention, Family Nurture Intervention
- Keywords
- Family Nurture Intervention, Martha G. Welch MD, Randomized Controlled Trial, Preschool Intervention, Pre-school Intervention, Multiple Family Group Intervention, Emotional Connection, Co-regulation
- 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.
Nutrition and Play InterventionBehavioural
Also called NPI
Mothers and children in the Nutrition and Play group will play educational and nutrition-focused games.
Family Nurture InterventionBehavioural
Also called FNI
The mother-child pair will be asked to talk and play with each other as they customarily do. 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 though sustained physical contact; comfort touch, soothing words, and eye contact.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and Play Intervention (NPI) | Active comparator | Half of the mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group. Receives: Behavioral: Nutrition and Play Intervention |
| Family Nurture Intervention (FNI) | Experimental | Half of the mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group. Receives: Behavioral: Family Nurture Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Welch Emotional Connection Scale (WECS) Score
This is designed to measure emotional connection. Children will be asked to sit on their mother's lap for five minutes. This interaction will be video taped, and will be behaviorally coded using the Welch Emotional Connection Scale (WECS) and using a paradigm evaluated in Noldus coding software.
The Welch Emotional Connection Scale (WECS) construct is emotional connection between mother and child, which we 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. At or below 2.25 on any individual item, or a total score below 9 means that the mother-child pair is not emotionally connected. 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: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start31 Jan 2018
- Primary completion25 Nov 2018
- Study completion25 Nov 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha G. Welch, MD, Columbia University
- Investigators
- Martha G Welch, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442439
- Sponsor's protocol ID
- AAAR5518
- Status last verified
- Apr 2019
- First submitted
- 2 Feb 2018
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stamford Group Family Nurture Intervention
- ClinicalTrials.gov ID
- NCT03442439
- Acronym / sponsor ID
- AAAR5518
- Keywords
- Family Nurture Intervention, Martha G. Welch MD, Randomized Controlled Trial, Preschool Intervention, Pre-school Intervention, Multiple Family Group Intervention, Emotional Connection, Co-regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 25 Nov 2018 (actual)
- Study completion
- 25 Nov 2018 (actual)
- First posted
- 22 Feb 2018 (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 current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral, and developmental disorders. The investigator hypothesizes that the children who are treated with Family Nurture Intervention (FNI), which incorporates interactive touch with vocal soothing, and family practice in comforting, will show increased emotional connection and mother child co-regulation with better results in the outcome measures in the short term and long term.
Detailed description
There are several early intervention programs that are available for children with emotional, behavioral and developmental disorders, ranging from behavioral treatment and sensory exposure therapy to pharmaceutical treatments. Although improvements in behavior have resulted from these interventions, they are limited in numerous ways. They are usually time-consuming, both for the child and the teacher or clinician providing the intervention. In order to see an effect of the intervention, most children must engage in the intervention procedure for several years. Moreover, the effects of most current intervention procedures are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable side effects that may modulate behavior, emotion, and physiological functions. The behavioral, neurobiological, and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition and Play Intervention (NPI) | Active comparator | Behavioral: Nutrition and Play InterventionHalf of the mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group. |
| Family Nurture Intervention (FNI) | Experimental | Behavioral: Family Nurture InterventionHalf of the mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group. |
Who may qualify
- Ages
- 24 to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child is a singleton
- Mother can speak, read and write in English or Spanish
- Child is between the ages of 2-4 1/2 years at date of enrollment
- Mother is 18 years of age or older at the time of consent
- Child resides with mother
Key exclusion criteria (10 listed)
- The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral palsy
- Child has a motor disability
- Mother sees or hears things that other people do not seem to see or hear
- Mother has trouble distinguishing whether something is real or part of imagination or dreams
- Mother is currently taking antipsychotic medications
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 |
|---|---|---|
| Nutrition and Play InterventionAlso: NPIMothers and children in the Nutrition and Play group will play educational and nutrition-focused games. | Behavioural | Nutrition and Play Intervention (NPI) |
| Family Nurture InterventionAlso: FNIThe mother-child pair will be asked to talk and play with each other as they customarily do. 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 though sustained physical contact; comfort touch, soothing words, and eye contact. | Behavioural | Family Nurture Intervention (FNI) |
Primary outcome
Welch Emotional Connection Scale (WECS) Score
Time frame: 12 months
This is designed to measure emotional connection. Children will be asked to sit on their mother's lap for five minutes. This interaction will be video taped, and will be behaviorally coded using the Welch Emotional Connection Scale (WECS) and using a paradigm evaluated in Noldus coding software. The Welch Emotional Connection Scale (WECS) construct is emotional connection between mother and child, which we 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. At or below 2.25 on any individual item, or a total score below 9 means that the mother-child pair is not emotionally connected. 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 8 Apr 2019.
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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.
Martha G 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 Nutrition and Play Intervention and Family Nurture Intervention in people with Behavior Problem and Developmental 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 8 inclusion and 10 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 8 Apr 2019. 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?
Welch Emotional Connection Scale (WECS) Score (time frame: 12 months). 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 8 Apr 2019.