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A feasibility study of the Parents under Pressure programme for improving outcomes for children and families affected by opioid-dependent fathers

Improving outcomes for children and families affected by paternal substance misuse: a feasibility study of the Parents under Pressure (PuP) programme for fathers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN43209618
Enrollment
24
Registered
2016-12-19
Start date
2017-04-01
Completion date
Unknown
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parental substance misuse and its effects on children and families Mental and Behavioural Disorders Parental substance misuse and its effects on children and families

Interventions

The Parents under Pressure (PuP) programme is an intensive manual-based home-visiting parenting intervention, delivered over a 24-week period by accredited PuP practitioners. In this study, PuP will b
Circle, a 3rd sector community-based early years' and family support service designed for the most disadvantaged families, especially those affected by parental substance misuse. Measures will be admi

Sponsors

University of Stirling
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Fathers who meet ICD-10 diagnostic criteria for opioid dependence who are prescribed opioid substitution therapy e.g. methadone, buprenorphine 2. Fathers with opioid dependence who also use other types of psychoactive substances (e.g. benzodiazepine, cocaine, cannabis or alcohol) are eligible for inclusion in this study, in recognition that poly-drug use is the norm 3. Mothers/partners of fathers recruited into the study are eligible to take part whether or not they have a diagnosis of substance dependence themselves 4. Each family will have at least one ‘index’ child aged 0-5 years old 5. Target children included in the study can be biological or non-biological children of the included father 6. Fathers must be involved in the day-to-day care of the index child 7. Fathers must have been in a relationship with the mother/partner for at least 6 months

Exclusion criteria

Exclusion criteria: 1. Either parent has a serious mental illness (e.g. active psychosis) which prevents them from fully participating in the programme 2. Families where domestic abuse or child abuse has resulted in the father being prohibited from contact with the target child or family 3. Families where the father is facing an imminent prison sentence of longer than 6 months, or a criminal justice order of longer than 6 months which would prohibit their active involvement in the programme 4. Either parent is under the age of 16 years and/or NOT officially resident in Lothian region

Design outcomes

Primary

MeasureTime frame
As this is a feasibility study, the main study outcome is whether the study meets pre-set progression criteria. However, the study will also test a range of outcome measures for acceptability and sensitivity to change for use in a subsequent trial. Feasibility outcomes: 1. Recruitment rate, recorded as the number of eligible families who consent to participate in the study by 12 months 2. Retention rates, recorded as the number of eligible families who complete the parenting programme and the number of families that remain in the study until the follow-up at 6 months 3. Acceptability of the intervention, assessed by parent (on completion or drop out of the programme), practitioner and referrer feedback (over the 12 month implementation phase), including analysis of barriers/facilitators to recruitment and retention 4. Successful implementation of the intervention in non-NHS settings, measured by the number of PuP practitioners trained to accreditation level who are retained in each delivery site, and continuing provision of the intervention in both delivery sites by the end of the study 5. Fidelity of intervention delivery, measured by a parent-reported bespoke PuP fidelity measure (on completion or drop out of the programme) 6. Acceptability and appropriateness of all outcome measures, measured by questionnaire completion rates and rates of missing data per questionnaire (at baseline, end-of-treatment, and 6 month follow-up)

Secondary

MeasureTime frame
Outcome measures for the family are assessed at baseline (pre-intervention), end-of-treatment (post-intervention) and at 6 months follow-up: 1. Child behaviour, measured by father and mother reported SDQ and BITSEA 2. Child protection outcomes, measured by father and mother reported B-CAPI and child protection 'at-risk' registrations, de-registrations and out-of-home placements (retrospective continuous data obtained from Social Work Scotland records at 6 month follow-up) 3. Quality of caregiving, measured by the Emotional Availability Scales (EAS) 4. Parenting knowledge, skills and competence, measured by the Parenting Sense of Competence Scale (PSCS) 5. Parental affect regulation, measured by the Difficulties in Emotion Regulation Scale (DERS) 6. Couple relationship functioning, measured by the Revised Conflict Tactics Scale (CTS2) 7. Substance use, measured by the Treatment Outcome Profile (TOP) and prescribed opioid substitution therapy (OST) daily dose (retrospective continuous data obtained from prescribing records at 6 month follow-up) 8. Health utility, measured by the EQ-5D-5L 9. Acceptability of health economics measures, assessed by father and mother feedback (via qualitative data at end-of treatment interview) and completion rates of service use questionnaires 10. Clinically significant change in outcomes for individual families, measured using the Reliable Change Index. This will determine whether there has been a reliable improvement in each of the key domains for both fathers and mothers on: DERS, EAS and B-CAPI (from baseline to end-of-treatment and 6 month follow-up)

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026