Infant DevelopmentNCT02895126
Assessment of the "Appui Parental": A Program of Early Support to Parenthood
A study testing "Appui Parental" program and Regular parental support in people with Infant Development, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In so-called at risk families, the child-parent attachment relationship is more difficult to set up and this can be a barrier to social and emotional development of young children. Read more about this study
- Who is it for?
- Ages 1 month to 20 months
- Conditions the study is for
- Infant Development
- What is being tested?
- "Appui Parental" program and Regular parental support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2014to 18 Oct 2022
- 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 1 month to 20 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- family with child between 1 and 20 months of age and with parents eligible to parental support,
- written informed consent signed by both parents or 1 legal guardian,
- vulnerability criteria with difficulties to meet the needs of their child,
- family affiliated to social security.
Who cannot join
- mother having delusional psychosis,
- family whose child is in danger and needs an immediate protective measure,
- ongoing justice procedure for the child,
- family with impossibility to follow-up during 18 months,
- non French-speaking parents.
Trial locations and contacts
1 site in 1 country.
About this study
In so-called at risk families, the child-parent attachment relationship is more difficult to set up and this can be a barrier to social and emotional development of young children. To help parents build and sustain this relationship, and to prevent child development disorders, many parenting programs have been created, usually with frequent home visits by early childhood professionals. In France, therapeutic interventions at home are little used and they are not evaluated.
In Montpellier, an action of this type has been conducted since 2001 by the "Conseil Départemental de l'Hérault" in collaboration with the University Hospital of Montpellier including, in addition to home visits, supervision of professionals: the Appui Parental Program.
Read more
Before extending this action to other areas of Herault, the "Conseil Départemental de l'Hérault", the "Abri Languedocien" and the University Hospital of Montpellier are conducting an assessment to know the effectiveness of the program for families under care.
This 3-year multicenter prospective study includes 88 children aged 1 to 20 months from families meeting vulnerability criteria previously defined, 44 benefiting Appui Parental program (experimental group) and 44 benefiting a regular support (control group).
A paediatric examination on the basis of the Denver scale, parental questionnaires, questionnaires to professionals and an a video of infant-parent interactions are used. The data, collected at baseline and 18 months later, will be compared.
Read the detailed description
Objective: the main objective of this study is to determine the efficiency of Appui Parental program by evaluating its impact on the development of children aged from 0 to 3 years. The secondary objectives are to study the effects of the intervention on: the mother-child interactions, the degree of therapeutic alliance between parent and professionals, the parenting skills feeling, perceived social support, anxiety and depression of parents, frequency of legal interventions (placements, educational measures). An assessment of stress among professionals involved in the study and evaluation of the therapeutic alliance with families will also be conducted to assess the effectiveness of the supervision included in the program.
Hypothesis: Scores on Symptom Check List after 18 months of follow up will be significantly higher in subjects who benefited the Appui Parental program compared to subjects with conventional parental support. Similarly, it is expected that other developmental assessments of children have the best results in the Appui Parental Program group than in the control group. Finally, it is assumed that the mother-child interactions, the parenting skills feeling, and the therapeutic alliance between parent and professional are better in the Appui Parental program than in the control group.
- Conditions
- Infant Development
- Being tested
- "Appui Parental" program, Regular parental support
- Keywords
- vulnerable family
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Appui Parental" programBehavioural
Regular parental supportBehavioural
| Study group | Role | What they receive |
|---|---|---|
| "Appui Parental" program (44 cases) | Experimental | Not described Receives: Behavioral: "Appui Parental" program |
| Regular parental support (44 cases) | Other | Usual intervention Receives: Behavioral: Regular parental support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Check-List (SCL) score variation
Measured: up to 18 months
Secondary outcomes (1)
Child Behavior Check-List (CBCL) score variation
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start4 Apr 2014
- Primary completion18 Oct 2022
- Study completion18 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895126
- Sponsor's protocol ID
- 9237
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2016
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the "Appui Parental": A Program of Early Support to Parenthood
- ClinicalTrials.gov ID
- NCT02895126
- Acronym / sponsor ID
- 9237
- Conditions
- Infant Development
- Keywords
- vulnerable family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 4 Apr 2014 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 9 Sep 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.
In so-called at risk families, the child-parent attachment relationship is more difficult to set up and this can be a barrier to social and emotional development of young children. To help parents build and sustain this relationship, and to prevent child development disorders, many parenting programs have been created, usually with frequent home visits by early childhood professionals. In France, therapeutic interventions at home are little used and they are not evaluated.
In Montpellier, an action of this type has been conducted since 2001 by the "Conseil Départemental de l'Hérault" in collaboration with the University Hospital of Montpellier including, in addition to home visits, supervision of professionals: the Appui Parental Program.
Before extending this action to other areas of Herault, the "Conseil Départemental de l'Hérault", the "Abri Languedocien" and the University Hospital of Montpellier are conducting an assessment to know the effectiveness of the program for families under care.
This 3-year multicenter prospective study includes 88 children aged 1 to 20 months from families meeting vulnerability criteria previously defined, 44 benefiting Appui Parental program (experimental group) and 44 benefiting a regular support (control group).
A paediatric examination on the basis of the Denver scale, parental questionnaires, questionnaires to professionals and an a video of infant-parent interactions are used. The data, collected at baseline and 18 months later, will be compared.
Detailed description
Objective: the main objective of this study is to determine the efficiency of Appui Parental program by evaluating its impact on the development of children aged from 0 to 3 years. The secondary objectives are to study the effects of the intervention on: the mother-child interactions, the degree of therapeutic alliance between parent and professionals, the parenting skills feeling, perceived social support, anxiety and depression of parents, frequency of legal interventions (placements, educational measures). An assessment of stress among professionals involved in the study and evaluation of the therapeutic alliance with families will also be conducted to assess the effectiveness of the supervision included in the program.
Hypothesis: Scores on Symptom Check List after 18 months of follow up will be significantly higher in subjects who benefited the Appui Parental program compared to subjects with conventional parental support. Similarly, it is expected that other developmental assessments of children have the best results in the Appui Parental Program group than in the control group. Finally, it is assumed that the mother-child interactions, the parenting skills feeling, and the therapeutic alliance between parent and professional are better in the Appui Parental program than in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Appui Parental" program (44 cases) | Experimental | Behavioral: "Appui Parental" program |
| Regular parental support (44 cases) | Other | Behavioral: Regular parental supportUsual intervention |
Who may qualify
- Ages
- 1 month to 20 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- family with child between 1 and 20 months of age and with parents eligible to parental support,
- written informed consent signed by both parents or 1 legal guardian,
- vulnerability criteria with difficulties to meet the needs of their child,
- family affiliated to social security.
Key exclusion criteria (5 listed)
- mother having delusional psychosis,
- family whose child is in danger and needs an immediate protective measure,
- ongoing justice procedure for the child,
- family with impossibility to follow-up during 18 months,
- non French-speaking parents.
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 |
|---|---|---|
| "Appui Parental" program | Behavioural | "Appui Parental" program (44 cases) |
| Regular parental support | Behavioural | Regular parental support (44 cases) |
Primary outcome
Symptom Check-List (SCL) score variation
Time frame: up to 18 months
1 secondary outcome
Child Behavior Check-List (CBCL) score variation
Time frame: up to 18 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 21 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Appui Parental" program and Regular parental support in people with Infant Development, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 5 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 21 Sep 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 France. 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?
Symptom Check-List (SCL) score variation (time frame: up to 18 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 21 Sep 2023.