Infant Mental HealthNCT04273698
What Can be Learnt From a Pilot Project Offering Brief Therapeutic Work to Parents and Infants in a Child and Adolescent Mental Health Service?
A study testing Parent-infant psychotherapy in people with Infant Mental Health, run by University of East London at 1 site in United Kingdom.
Trial summary
Can a method of working therapeutically with parents and children (under the age of five) be made use of in a Child and Adolescent Mental Health team, in which this kind of work does not regularly take place? I hope to understand whether this model of work can be helpful to the children and their families and to look… Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Infant Mental Health
- What is being tested?
- Parent-infant psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2018to 30 Oct 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 Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The participants in this trial were children under the age of five years old, who had been referred to the CAMHS clinic.
- The child could have been experiencing a range of difficulties, including issues with sleeping, feeding or attachment, which were having an impact on their, or their families, functioning and wellbeing.
- The work involved working with the referred child and their parent(s) or carers
Who cannot join
- Families involved in court proceedings
- Families where there were safeguarding concerns
- Families currently experiencing domestic violence
- Families for whom severe parental mental health difficulties were indicated at the point of referral.
- Families who were already been accessing mental health support
- If the child had severe developmental difficulties and would require a specialist service
- Families requiring an interpreter in order to participate, I would have been unable to involve them, owing to the level of complexity this would have added in terms of the communication.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Shelley Clinic, CAMHS team, Dorset NHS
Bournemouth, BH1 4LB
About this study
Official title: What Can be Learnt From Offering Therapeutic Work to Parents and Infants (Under the Age of Five) in a Child and Adolescent Mental Health Service (CAMHS) Clinic That Does Not Routinely Offer This Type of Intervention?
Can a method of working therapeutically with parents and children (under the age of five) be made use of in a Child and Adolescent Mental Health team, in which this kind of work does not regularly take place? I hope to understand whether this model of work can be helpful to the children and their families and to look at how this method was received by the team.
It is hoped that by working with the parents and child together, the families will be able to think about both the child's presenting difficulty, but also the relationship between the parents and their child and how the parents' own experiences and difficulties might impact on the present situation.
Read the detailed description
The primary aim of this research is to trial an under-fives' service, in a Child and Adolescent Mental Health Service (CAMHS) team which has not offered this kind of work specifically before. The project would involve recruiting families, with children under the age of five years old, who are experiencing one or more difficulties, and these families would be offered five sessions, with the option of an additional five sessions, should this be required.
The work will broadly follow the Tavistock's model of parent-infant psychotherapy and the sessions will be centred within a psychodynamic psychotherapeutic framework. I hope that this trial will enable to me to learn more about this model of work, in terms of the processes involves and the themes that emerge. I hope to see how possible it is for this kind of work to be adopted within a generic CAMHS team, and how it is received by the families involved.
Due to this method of working being new to the team, it will be interesting to see how my colleagues respond to the model. It is likely that trying to gather full qualitative or quantitative data in this area would be beyond the scope of this piece of research, but I hope to make some reflections on how the model was received by the team. I hope to present the plan of work to the team prior to the treatment stage, and then share some of the findings from the research, after treatment. I also hope to conduct some form of consultation, with a staff group, following the treatment stage, in order to hear about their experiences of this method.
- Conditions
- Infant Mental Health
- Being tested
- Parent-infant psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-infant psychotherapyBehavioural
Brief psychoanalytic parent-infant psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Clinical intervention | Experimental | The project involved recruiting families, with children under the age of five years old, who were experiencing one or more difficulties, and these families were offered five therapeutic sessions, based on a psychodynamic parent-infant psychotherapy approach. Receives: Behavioral: Parent-infant psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To learn how this method of therapeutic intervention was received by the families involved. The data gathered (in the form of process notes) from the interviews and therapy sessions was analysed using Thematic Analysis (Braun and Clarke, 2006).
The primary aim of this research was to trial an under-fives' service (like that developed at the Tavistock Clinic), in a CAMHS team which had not offered this kind of work specifically before, and to learn about the responses of families. The data gathered (in the form of process notes) from the interviews and therapy sessions was analysed using Thematic Analysis (Braun and Clarke, 2006).
Measured: 6 months
Secondary outcomes (2)
Goal Based Outcomes (GBO) measure
Each family was asked to set a goal which addressed the current problems or difficulties that they wanted to focus on during the therapy sessions. They were asked to rate their goal from zero to ten, zero representing that the goal is currently not being achieved at all, and ten meaning the goal has been entirely met. These goals were set at the start of treatment and reviewed and re-rated at the end.
Measured: 6 months
Experience of Service questionnaire
At the end of the intervention, parents were also asked to complete an ESQ, which is a patient satisfaction measure, assessing their experience of the service, the intervention and clinic.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start30 Apr 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Mental HealthStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Five families were each offered five parent-child psychotherapy sessions, based on the Tavistock Under-Fives model, and data was gathered and analysed from both the clinical intervention and from interviews and standardised outcome measures.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Allender, University of East London
- Investigators
- Margaret Lush, Study director, Tavistock and Portman Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273698
- Sponsor's protocol ID
- 18/SW/0020
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Can be Learnt From Offering Therapeutic Work to Parents and Infants (Under the Age of Five) in a Child and Adolescent Mental Health Service (CAMHS) Clinic That Does Not Routinely Offer This Type of Intervention?
- ClinicalTrials.gov ID
- NCT04273698
- Acronym / sponsor ID
- 18/SW/0020
- Conditions
- Infant Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of East LondonUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 18 Feb 2020 (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.
Can a method of working therapeutically with parents and children (under the age of five) be made use of in a Child and Adolescent Mental Health team, in which this kind of work does not regularly take place? I hope to understand whether this model of work can be helpful to the children and their families and to look at how this method was received by the team.
It is hoped that by working with the parents and child together, the families will be able to think about both the child's presenting difficulty, but also the relationship between the parents and their child and how the parents' own experiences and difficulties might impact on the present situation.
Detailed description
The primary aim of this research is to trial an under-fives' service, in a Child and Adolescent Mental Health Service (CAMHS) team which has not offered this kind of work specifically before. The project would involve recruiting families, with children under the age of five years old, who are experiencing one or more difficulties, and these families would be offered five sessions, with the option of an additional five sessions, should this be required.
The work will broadly follow the Tavistock's model of parent-infant psychotherapy and the sessions will be centred within a psychodynamic psychotherapeutic framework. I hope that this trial will enable to me to learn more about this model of work, in terms of the processes involves and the themes that emerge. I hope to see how possible it is for this kind of work to be adopted within a generic CAMHS team, and how it is received by the families involved.
Due to this method of working being new to the team, it will be interesting to see how my colleagues respond to the model. It is likely that trying to gather full qualitative or quantitative data in this area would be beyond the scope of this piece of research, but I hope to make some reflections on how the model was received by the team. I hope to present the plan of work to the team prior to the treatment stage, and then share some of the findings from the research, after treatment. I also hope to conduct some form of consultation, with a staff group, following the treatment stage, in order to hear about their experiences of this method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Five families were each offered five parent-child psychotherapy sessions, based on the Tavistock Under-Fives model, and data was gathered and analysed from both the clinical intervention and from interviews and standardised outcome measures.
| Arm | Type | Receives |
|---|---|---|
| Clinical intervention | Experimental | Behavioral: Parent-infant psychotherapyThe project involved recruiting families, with children under the age of five years old, who were experiencing one or more difficulties, and these families were offered five therapeutic sessions, based on a psychodynamic parent-infant psychotherapy approach. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The participants in this trial were children under the age of five years old, who had been referred to the CAMHS clinic.
- The child could have been experiencing a range of difficulties, including issues with sleeping, feeding or attachment, which were having an impact on their, or their families, functioning and wellbeing.
- The work involved working with the referred child and their parent(s) or carers
Key exclusion criteria (7 listed)
- Families involved in court proceedings
- Families where there were safeguarding concerns
- Families currently experiencing domestic violence
- Families for whom severe parental mental health difficulties were indicated at the point of referral.
- Families who were already been accessing mental health support
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 |
|---|---|---|
| Parent-infant psychotherapyBrief psychoanalytic parent-infant psychotherapy | Behavioural | Clinical intervention |
Primary outcome
To learn how this method of therapeutic intervention was received by the families involved. The data gathered (in the form of process notes) from the interviews and therapy sessions was analysed using Thematic Analysis (Braun and Clarke, 2006).
Time frame: 6 months
The primary aim of this research was to trial an under-fives' service (like that developed at the Tavistock Clinic), in a CAMHS team which had not offered this kind of work specifically before, and to learn about the responses of families. The data gathered (in the form of process notes) from the interviews and therapy sessions was analysed using Thematic Analysis (Braun and Clarke, 2006).
2 secondary outcomes
Goal Based Outcomes (GBO) measure
Time frame: 6 months
Experience of Service questionnaire
Time frame: 6 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 18 Feb 2020.
- 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.
Margaret Lush study director
Tavistock and Portman Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-infant psychotherapy in people with Infant Mental Health, run by University of East London at 1 site in United Kingdom.
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 3 inclusion and 7 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 18 Feb 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 Kingdom. 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?
To learn how this method of therapeutic intervention was received by the families involved. The data gathered (in the form of process notes) from the interviews and therapy sessions was analysed using Thematic Analysis (Braun and Clarke, 2006). (time frame: 6 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 18 Feb 2020.