Behavior ProblemNCT02970565
Family Nurture Intervention, A Group Model in Connecticut
A study testing Family Nurture Intervention and Nutrition and Play 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 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, Development Delay, Emotional Disturbance
- What is being tested?
- Family Nurture Intervention and Nutrition and Play Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to May 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 54 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is a singleton
- Mother can speak in English or Spanish
- Child is between the ages of 2 to 4 ½ years at date of enrollment
- Mother is 18 years of age or older at the time of consent
- Child demonstrates developmental deficit as measured by the SDQ (cutoff of 13 or more on the total score excluding the pro-social questions; OR 4 or less on the pro-social questions, which are reverse scored i.e. higher is better)
- Child must reside 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
- 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 has any current involvement with Child Protective Services (Department of Children and Families)
- Mother is pregnant
- Mother and/or infant has a medical condition or contagion that precludes intervention components
Trial locations and contacts
1 site in 1 country.
United States1 site
Norwalk Housing Authority
Cos Cob, Connecticut, 06807
About this study
Official title: Family Nurture Intervention, A Group Model: Short and Long Term Effects on Behavior and Development of Preschool Aged Children
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
- Family Nurture Intervention, Nutrition and Play Intervention
- Keywords
- Family Nurture Intervention, Martha G. Welch MD, Randomized Control Trial, Pre-school Intervention, Preschool 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.
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 through sustained physical contact, comfort touch, soothing words, and eye contact.
Nutrition and Play InterventionBehavioural
Also called NPI
Mothers and children in the Play and Nutrition group will play educational and nutrition-focused games.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and Play Intervention | Experimental | 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 | Experimental | 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.
Change in Childhood Behavior Checklist (CBCL) Score
The Childhood Behavior Checklist (CBCL) is a device by which parents or other individuals who know the child well rate a child's problem behaviors and competencies. This instrument can either be self-administered or administered through an interview. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The first section of this questionnaire consists of 20 competence items and the second section consists of 120 items on behavior or emotional problems.
Measured: Baseline, 6 months
Secondary outcomes (3)
Co-regulation of Vagal Tone
Using ECG data obtained during each follow-up visit, the investigators will characterize various parameters of cardiac function and regulation including assessments of parasympathetic modulation of heart rate. Long term individual differences in attention and emotional regulation are correlated with these parameters. Heart rate and respiration obtained from analogue outputs from standard clinical monitors or from specially designed hardware utilized routinely in the studies of human infants. The digitized recordings of ECG and respiration will be processed using software designed specifically for displaying, marking, and analyzing data from these records.
Measured: Up to 12 months
Change in Maternal Anxiety and Depressive Symptoms
Mothers will complete various questionnaires measuring their mood and state.
Measured: Up to 12 months
Changes in Welch Emotional Connection Scale
This is a clinical tool to assess the emotional connectedness of a mother-child dyad. The aim of the WECS is to assess behaviors observed during mother-child interaction, and score these behavioral observations across four domains to better inform health professionals of a dyad's interventional need. This scale will be completed by study staff.
Measured: Up to 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 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2019
- Study completionMay 2019
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 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha G Welch, Columbia University
- Investigators
- Martha G Welch, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970565
- Sponsor's protocol ID
- AAAQ9547
- Status last verified
- Feb 2023
- First submitted
- 18 Nov 2016
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Welch MG, Ludwig RJ, Hane AA, Austin J, Markowitz ES, Jaffe ME, Myers MM. Preschool-based mother-child emotional preparation program improves emotional connection, behavior regulation in the home and classroom: a randomized controlled trial. Front Child Adolesc Psychiatry. 2023 Oct 20;2:1232515. doi: 10.3389/frcha.2023.1232515. eCollection 2023.
PubMed 39816857
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Nurture Intervention, A Group Model: Short and Long Term Effects on Behavior and Development of Preschool Aged Children
- ClinicalTrials.gov ID
- NCT02970565
- Acronym / sponsor ID
- AAAQ9547
- Keywords
- Family Nurture Intervention, Martha G. Welch MD, Randomized Control Trial, Pre-school Intervention, Preschool Intervention, Multiple Family Group Intervention, Emotional Connection, Co-regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 22 Nov 2016 (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.
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 | Experimental | Behavioral: Nutrition and Play InterventionMother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group. |
| Family Nurture Intervention | Experimental | Behavioral: Family Nurture InterventionMother-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 (6 listed)
- Child is a singleton
- Mother can speak in English or Spanish
- Child is between the ages of 2 to 4 ½ years at date of enrollment
- Mother is 18 years of age or older at the time of consent
- Child demonstrates developmental deficit as measured by the SDQ (cutoff of 13 or more on the total score excluding the pro-social questions; OR 4 or less on the pro-social questions, which are reverse scored i.e. higher is better)
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
- 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 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 through sustained physical contact, comfort touch, soothing words, and eye contact. | Behavioural | Family Nurture Intervention |
| Nutrition and Play InterventionAlso: NPIMothers and children in the Play and Nutrition group will play educational and nutrition-focused games. | Behavioural | Nutrition and Play Intervention |
Primary outcome
Change in Childhood Behavior Checklist (CBCL) Score
Time frame: Baseline, 6 months
The Childhood Behavior Checklist (CBCL) is a device by which parents or other individuals who know the child well rate a child's problem behaviors and competencies. This instrument can either be self-administered or administered through an interview. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The first section of this questionnaire consists of 20 competence items and the second section consists of 120 items on behavior or emotional problems.
3 secondary outcomes
Co-regulation of Vagal Tone
Time frame: Up to 12 months
Change in Maternal Anxiety and Depressive Symptoms
Time frame: Up to 12 months
Changes in Welch Emotional Connection Scale
Time frame: Up to 12 months
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 15 Feb 2023.
- Derived from this study: PubMed 39816857Welch MG, Ludwig RJ, Hane AA, Austin J, Markowitz ES, Jaffe ME, Myers MM. Preschool-based mother-child emotional preparation program improves emotional connection, behavior regulation in the home and classroom: a randomized controlled trial. Front Child Adolesc Psychiatry. 2023 Oct 20;2:1232515. doi: 10.3389/frcha.2023.1232515. eCollection 2023.
- 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.
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 Family Nurture Intervention and Nutrition and Play 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 6 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 15 Feb 2023. 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?
Change in Childhood Behavior Checklist (CBCL) Score (time frame: Baseline, 6 months). 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 NCT02970565, 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 15 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.